Hormone · Profile

Exemestane

Aromasin · Steroidal AI

Hormone ManagementZugelassen

MW: 296.4g/mol
Formula: C20H24O2

Exemestan ist ein steroidaler Aromatasehemmer, der hauptsächlich in den Nebennieren produziert wird und eine entscheidende Rolle in der Biosynthese von Östrogenen spielt. Forscher untersuchen Exemestan hauptsächlich hinsichtlich seiner Wirksamkeit bei der Behandlung von östrogenrezeptor-positivem Brustkrebs, insbesondere bei postmenopausalen Frauen. Wichtige Ergebnisse aus aktuellen Studien zeigen, dass Exemestan, wenn es mit dem mTOR-Hemmer Everolimus kombiniert wird, die progressionsfreie Überlebenszeit im Vergleich zu Exemestan allein signifikant verbessert, was auf eine erhöhte therapeutische Wirksamkeit bei Patienten mit Resistenzen gegen frühere Behandlungen hinweist. Darüber hinaus zeigen klinische Beweise, dass die Kombination von Exemestan mit anderen Wirkstoffen, wie Entinostat, die progressionsfreie Überlebenszeit bei fortgeschrittenen Brustkrebssettings weiter verlängern kann. Aktuelle Forschungen untersuchen weiterhin die optimale Verwendung von Exemestan in verschiedenen Behandlungsregimen und heben seine Relevanz im fortwährenden Kampf gegen hormonsensitive Malignome hervor.

Overview

Übersicht

Exemestan ist eine synthetische steroidale Verbindung, die als Aromatasehemmer klassifiziert wird. Es wird hauptsächlich zur Behandlung von hormonsensitivem Brustkrebs eingesetzt. Exemestan ist chemisch mit dem natürlichen Substrat Androstendion verwandt und wird synthetisch für therapeutische Zwecke hergestellt. Als Mitglied der Klasse der steroidalen Aromatasehemmer unterscheidet es sich von nicht-steroidalen Hemmstoffen wie Letrozol und Anastrozol. Forscher haben sich auf die Rolle von Exemestan bei der Reduzierung der Östrogenspiegel bei postmenopausalen Frauen konzentriert, was entscheidend für die Behandlung von östrogenrezeptor-positivem Brustkrebs ist. Es wird auch in Kombinationstherapien, wie mit mTOR-Hemmern wie Everolimus, untersucht, um Resistenzen gegen endokrine Therapien zu überwinden. Exemestan wirkt, indem es irreversibel an das Aromataseenzym bindet und dieses hemmt, welches für die Umwandlung von Androgenen in Östrogene in peripheren Geweben verantwortlich ist. Diese Hemmung führt zu einer signifikanten Reduktion der zirkulierenden Östrogenspiegel, wodurch das Wachstum östrogenabhängiger Tumoren verlangsamt wird. Pharmakokinetisch hat Exemestan eine Halbwertszeit von etwa 24 Stunden, was eine einmal tägliche orale Einnahme ermöglicht. Es wird hauptsächlich in der Leber durch Oxidation und Reduktion metabolisiert, und seine Bioverfügbarkeit wird erhöht, wenn es mit Nahrung eingenommen wird. Klinisch ist Exemestan für die Anwendung bei postmenopausalen Frauen mit fortgeschrittenem Brustkrebs zugelassen, insbesondere nach dem Fortschreiten der Erkrankung nach nicht-steroidalen Aromatasehemmern. Es wird von Regulierungsbehörden weltweit, einschließlich der FDA, für seine Wirksamkeit in diesem Kontext anerkannt.

Chemical profile

Chemische Struktur

Formel	C20H24O2
Molekulargewicht	296.4g/mol
CAS-Nummer	107868-30-4
PubChem CID	60198

Mechanism

Wirkmechanismus

Exemestan wirkt auf das Aromataseenzym, was zur irreversiblen Hemmung der Östrogenbiosynthese führt. Diese Reduktion der Östrogenspiegel führt zu einer verringerten Stimulation von östrogenrezeptor-positiven Brustkrebszellen, wodurch das Tumorwachstum gehemmt wird.

Mechanism

Signalweg

Exemestan ist ein steroidaler Aromatasehemmer, der irreversibel an das Aromataseenzym bindet und die Umwandlung von Androgenen in Östrogene in peripheren Geweben hemmt, wodurch die Östrogenspiegel gesenkt werden. Diese Wirkung betrifft hauptsächlich östrogenrezeptor-positive (ER+) Brustkrebszellen, was zu einer verringerten Aktivierung der Signalwege des Östrogenrezeptors und folglich zu einer Hemmung der Zellproliferation und des Tumorwachstums führt. Der vollständige Wirkmechanismus ist nicht vollständig verstanden, insbesondere hinsichtlich der nachgelagerten Effekte auf verschiedene Signalwege, die an Krebsresistenz und -progression beteiligt sind.

Solubility

Löslichkeit

Exemestan ist in Wasser schlecht löslich, aber in Ethanol und organischen Lösungsmitteln löslich.

Rechtlicher Status

🇩🇪DE

Verschreibungspflichtig; keine kontrollierte Substanz gemäß BtMG.

🇺🇸US

FDA-zugelassen für die Verschreibung; keine kontrollierte Substanz.

🇦🇺AU

TGA Schedule 4 (verschreibungspflichtiges Medikament).

🇬🇧UK

Verschreibungspflichtiges Medikament (POM) gemäß MHRA-Vorschriften.

Informationen zum rechtlichen Status dienen nur der allgemeinen Orientierung und spiegeln möglicherweise nicht die aktuellsten regulatorischen Änderungen wider. Überprüfe immer die offiziellen behördlichen Quellen, bevor du Entscheidungen triffst.

Open Questions

Offene Forschungsfragen

Aktuelle Beweise sind begrenzt hinsichtlich der langfristigen Wirksamkeit und Sicherheit von Exemestan in Kombination mit mTOR-Hemmern, insbesondere in unterschiedlichen Populationen und bei Patienten mit verschiedenen Stadien von Brustkrebs. Darüber hinaus heben widersprüchliche Ergebnisse zur Wirksamkeit von Exemestan im Vergleich zu anderen Aromatasehemmern, wie Letrozol, bei der Behandlung von Erkrankungen wie Endometriose die Notwendigkeit größerer randomisierter kontrollierter Studien hervor, um diese Unterschiede zu klären. Weitere Forschung ist erforderlich, um die spezifischen Mechanismen der Resistenz gegen Exemestan und die Rolle von Biomarkern, wie der Acetylierung von Lysin-Proteinen, bei der Vorhersage von Behandlungsergebnissen zu untersuchen.

159 Forschungspublikationen

4,470

Zitierungen gesamt

Human/RCT

3.3

Ø Einfluss

2020

Neueste

Sortierung

Filter

01Top

#01

Adjuvantes Exemestan mit ovarialer Suppression bei prämenopausalem Brustkrebs.

Pagani Olivia, et al. · The New England journal of medicine · 2014

HumanInfluence31.0

712

Forscher beobachteten, dass die adjuvante Behandlung mit Exemestan plus ovarialer Suppression das krankheitsfreie Überleben im Vergleich zu Tamoxifen plus ovarialer Suppression bei prämenopausalen Frauen mit hormonrezeptor-positivem frühem Brustkrebs signifikant verbesserte.

Key findings

01Exemestan plus ovarialer Suppression reduzierte signifikant das Risiko eines Krebsrezidivs im Vergleich zu Tamoxifen plus ovarialer Suppression.
02Die 5-Jahres-krankheitsfreie Überlebensrate betrug 91,1% für die Exemestan-Gruppe.
03Die Gesamtüberlebensraten waren zwischen den beiden Behandlungsgruppen ähnlich.

PubMed

02Top

#02

Anpassung der adjuvanten endokrinen Therapie bei prämenopausalen Brustkrebspatientinnen.

Francis Prudence A, et al. · The New England journal of medicine · 2018

HumanInfluence34.0

580

Forscher beobachteten, dass prämenopausale Frauen, die Exemestan plus ovarielle Suppression erhielten, signifikant niedrigere Rückfallraten aufwiesen im Vergleich zu denen, die Tamoxifen plus ovarielle Suppression erhielten, was einen Vorteil des ersteren Behandlungsregimes anzeigt.

Key findings

01Exemestan plus ovarielle Suppression führte zu niedrigeren Rückfallraten als Tamoxifen plus ovarielle Suppression.
02Tamoxifen plus ovarielle Suppression verbesserte die Überlebensraten im Vergleich zu Tamoxifen allein.
03Höhere Raten von Nebenwirkungen wurden in Gruppen beobachtet, die ovarielle Suppression erhielten.

PubMed

03Top

#03

Adjuvante Tamoxifen und Exemestan bei frühem Brustkrebs (TEAM): eine randomisierte Phase-3-Studie.

HumanInfluence17.0

373

Die Studie zeigte keinen signifikanten Unterschied in der krankheitsfreien Überlebenszeit zwischen der Exemestan-Monotherapie und der sequenziellen Behandlung mit Tamoxifen gefolgt von Exemestan bei postmenopausalen Frauen mit hormonrezeptor-positivem frühem Brustkrebs.

PubMed

#04

Verbesserung der oralen Bioverfügbarkeit von Exemestan durch ein selbstmikroemulgierendes Arzneimittelabgabesystem (SMEDDS).

AnimalInfluence4.0

161

Forscher beobachteten, dass ein selbstmikroemulgierendes Arzneimittelabgabesystem die orale Bioverfügbarkeit von Exemestan bei weiblichen Wistar-Ratten signifikant verbesserte.

PubMed

#05

Adjuvante Exemestan mit Ovarialunterdrückung bei prämenopausalen Brustkrebspatientinnen: Langzeitnachbeobachtung der kombinierten TEXT- und SOFT-Studien.

HumanInfluence9.0

137

Die Studie zeigte, dass adjuvante Exemestan plus Ovarialfunktionsunterdrückung das krankheitsfreie Überleben und das distant recurrence-free interval im Vergleich zu Tamoxifen plus Ovarialfunktionsunterdrückung bei prämenopausalen Frauen mit Brustkrebs nach 13 Jahren Nachbeobachtung signifikant verbesserte.

PubMed

#06

Die BOLERO-2-Studie: Die Hinzufügung von Everolimus zu Exemestan bei der Behandlung von postmenopausalem, hormonrezeptor-positivem, fortgeschrittenem Brustkrebs.

HumanInfluence3.0

123

Forscher beobachteten, dass die Hinzufügung von Everolimus zu Exemestan die progressionsfreie Überlebenszeit bei postmenopausalen Frauen mit hormonrezeptor-positivem, fortgeschrittenem Brustkrebs signifikant verbessert.

PubMed

#07

ESR1-Mutationen und Gesamtüberleben bei Fulvestrant versus Exemestan bei fortgeschrittenem hormonrezeptor-positivem Brustkrebs: Eine kombinierte Analyse der Phase-III-Studien SoFEA und EFECT.

Turner Nicholas C, et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2020

HumanInfluence5.0

121

Die Studie zeigte, dass Patienten mit ESR1-Mutationen ein schlechteres progressionsfreies und Gesamtüberleben hatten, wenn sie mit Exemestan im Vergleich zu Fulvestrant bei fortgeschrittenem hormonrezeptor-positivem Brustkrebs behandelt wurden.

Key findings

01Fulvestrant und Exemestan wurden bei Patienten verglichen, die auf vorherige Therapien fortgeschritten waren.
02Die Studie umfasste die Analyse von Serum- und Plasmaproben von Hunderten von Patienten.
03Die Studien zielten darauf ab, die Behandlungsoptionen für metastasierenden Brustkrebs zu verbessern.

PubMed

#08

Aromatasehemmer: Gibt es Unterschiede zwischen steroidalen und nicht-steroidalen Aromatasehemmern und sind sie relevant?

ReviewInfluence3.0

115

Die Studie zeigte, dass steroidale Aromatasehemmer wie Exemestan unterschiedliche Wechselwirkungen und klinische Implikationen im Vergleich zu nicht-steroidalen Aromatasehemmern bei der Behandlung von Brustkrebs haben können.

PubMed

#09

Exemestan (FCE 24304), ein neuer steroidaler Aromatasehemmer.

HumanInfluence1.0

Forscher beobachteten, dass Exemestan ein potenter irreversibler Aromatasehemmer mit einem günstigen Sicherheitsprofil und signifikanter Östrogensuppression bei postmenopausalen Frauen ist.

PubMed

#10

Endokrine und klinische Endpunkte von Exemestan als neoadjuvante Therapie.

ReviewInfluence1.0

Forscher beobachteten, dass Exemestan die Aromatisierung und das Tumorvolumen bei postmenopausalen Frauen mit östrogenrezeptorreichen Tumoren während der neoadjuvanten Therapie signifikant reduzierte.

PubMed

Klinische Studien (134)

Preclinical

Phase I

Phase II

Phase III

Approved

134

Studien gesamt

99,281

Teilnehmer gesamt

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole

NCT05635357COMPLETED

Sponsor

Brigham and Women's Hospital

Teilnehmer

16,989

Beginn

2022

Primärer Endpunkt

Time to dementia onset

Breast Cancer

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

NCT04852081UNKNOWN

Sponsor

Blokhin's Russian Cancer Research Center

Teilnehmer

1,000

Beginn

2021

Primärer Endpunkt

To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow

Breast Cancer Stage IV

Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)

NCT01050634COMPLETED

Sponsor

Pfizer

Teilnehmer

980

Beginn

2005

Primärer Endpunkt

Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores

Post Menopausal Women With Early Breast Cancer

Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

NCT00932165COMPLETED

Sponsor

Pfizer

Teilnehmer

451

Beginn

2004

Primärer Endpunkt

Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane

Breast Neoplasms

Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy

NCT02753686COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

440

Beginn

2016

Primärer Endpunkt

Duration on Treatment

HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

NCT01305239TERMINATED

Sponsor

Pfizer

Teilnehmer

398

Beginn

2008

Primärer Endpunkt

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Breast Cancer

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

NCT01121549TERMINATED

Sponsor

Pfizer

Teilnehmer

378

Beginn

2010

Primärer Endpunkt

Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity

Invasive Early Breast Cancer

Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

NCT04389424UNKNOWN

Sponsor

Instituto Jalisciense de Cancerologia

Teilnehmer

300

Beginn

2017

Primärer Endpunkt

Hidroxy Vitamin D Concentration

Breast CancerEndocrine TherapyEndocrine Therapy Adverse ReactionVitamin D DeficiencyNutrition DisordersObesity

Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane

NCT02109913UNKNOWN

Sponsor

Amsterdam UMC, location VUmc

Teilnehmer

175

Beginn

2014

Primärer Endpunkt

Biomarker Evaluation from Primary Tumor Tissue, New Tumor Biopsies and Blood Samples

Hormone Receptor Positive Malignant Neoplasm of BreastMetastatic Breast Cancer

Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer

NCT00066586COMPLETED

Sponsor

NCIC Clinical Trials Group

Teilnehmer

Beginn

2001

Primärer Endpunkt

Change in breast density as measured by Boyd Scale at 1 year

Breast Cancer

Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

NCT01814397COMPLETED

Sponsor

University of Michigan Rogel Cancer Center

Teilnehmer

Beginn

2009

Primärer Endpunkt

Mean Pain50 Assessed at Baseline, 3 Months and 6 Months

Breast CancerPainArthralgia

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

NCT01239745TERMINATED

Sponsor

Pfizer

Teilnehmer

Beginn

2011

Primärer Endpunkt

Number of Participants With Adverse Events (AEs)

Breast Neoplasms

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

NCT01720602COMPLETED

Sponsor

University of Washington

Teilnehmer

Beginn

2012

Primärer Endpunkt

Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease

NCT00200174COMPLETED

Sponsor

Memorial Sloan Kettering Cancer Center

Teilnehmer

Beginn

1999

Primärer Endpunkt

To evaluate the clinical safety and toxicity of raloxifene in combination with exemestane in postmenopausal women with a hx of AJCC Stage 0, I, II, or III breast cancer, who have no clinical evidence of disease, after completion of all planned adjuvant

Breast Cancer

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy

NCT01153672COMPLETED

Sponsor

University of Washington

Teilnehmer

Beginn

2010

Primärer Endpunkt

Rate of Clinical Benefit According to RECIST

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

NCT02023359COMPLETED

Sponsor

Novartis Healthcare A/S

Teilnehmer

Beginn

2013

Primärer Endpunkt

Adverse Events

Breast Cancer

A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

NCT00649090Phase 4COMPLETED

Sponsor

Pfizer

Teilnehmer

1,549

Beginn

2005

Primärer Endpunkt

Assess for serious adverse events

Breast Neoplasms

Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

NCT01176916Phase 4COMPLETED

Sponsor

Pfizer

Teilnehmer

564

Beginn

2011

Primärer Endpunkt

Time-to-Event

Breast Neoplasms

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

NCT00036270Phase 3COMPLETED

Sponsor

Pfizer

Teilnehmer

9,779

Beginn

2001

Primärer Endpunkt

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

Breast Neoplasms

Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

NCT00279448Phase 3COMPLETED

Sponsor

Pfizer

Teilnehmer

9,779

Beginn

2002

Primärer Endpunkt

To compare recurrence free survival between two treatment groups.

Breast Neoplasms

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

NCT00066573Phase 3COMPLETED

Sponsor

NCIC Clinical Trials Group

Teilnehmer

7,576

Beginn

2003

Primärer Endpunkt

Event-free Survival

Breast Cancer

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

NCT00038467Phase 3COMPLETED

Sponsor

Pfizer

Teilnehmer

4,740

Beginn

1998

Primärer Endpunkt

Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study

Breast Neoplasms

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer

NCT00003418Phase 3UNKNOWN

Sponsor

International Collaborative Cancer Group

Teilnehmer

4,400

Beginn

1998

Breast Cancer

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

NCT00032136Phase 3COMPLETED

Sponsor

Cancer Research Campaign Clinical Trials Centre

Teilnehmer

4,400

Beginn

2001

Primärer Endpunkt

Relapse-free survival

Breast Cancer

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

NCT06492616Phase 3RECRUITING

Sponsor

Stemline Therapeutics, Inc.

Teilnehmer

4,220

Beginn

2024

Primärer Endpunkt

Invasive Breast Cancer-Free Survival (IBCFS)

Breast Cancer

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

NCT06223698Phase 3NOT_YET_RECRUITING

Sponsor

Region Örebro County

Teilnehmer

3,832

Beginn

2025

Primärer Endpunkt

Overall survival

Breast Cancer

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066690Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Teilnehmer

3,066

Beginn

2003

Primärer Endpunkt

Disease-free Survival

Estrogen Receptor Positive Breast CancerProgesterone Receptor Positive TumorRecurrent Breast CarcinomaStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast Cancer

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066703Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Teilnehmer

2,672

Beginn

2003

Primärer Endpunkt

Disease-free Survival

Breast Cancer

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

NCT07391774Phase 3RECRUITING

Sponsor

National Cancer Institute (NCI)

Teilnehmer

1,978

Beginn

2026

Primärer Endpunkt

Invasive breast cancer-free survival (iBCFS)

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast Carcinoma

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

NCT04852887Phase 3RECRUITING

Sponsor

NRG Oncology

Teilnehmer

1,670

Beginn

2021

Primärer Endpunkt

Time to invasive or noninvasive IBTR.

Stage I Breast Cancer

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

NCT05827081Phase 3RECRUITING

Sponsor

Novartis Pharmaceuticals

Teilnehmer

1,400

Beginn

2024

Primärer Endpunkt

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years

Early Breast Cancer

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

NCT04975308Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Eli Lilly and Company

Teilnehmer

874

Beginn

2021

Primärer Endpunkt

Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)

Breast NeoplasmsNeoplasm Metastasis

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

NCT05891093Phase 3RECRUITING

Sponsor

Fudan University

Teilnehmer

766

Beginn

2023

Primärer Endpunkt

invasive disease free survival (iDFS)

Breast Cancer

Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer

NCT02404051Phase 3UNKNOWN

Sponsor

Consorzio Oncotech

Teilnehmer

745

Beginn

2015

Primärer Endpunkt

Progression-free survival (PFS1)

Metastatic Breast CancerBreast CancerHormone Receptor Positive TumorHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastLocally Advanced Malignant Neoplasm

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

NCT00863655Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

724

Beginn

2009

Primärer Endpunkt

Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.

Breast Cancer

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

NCT00065325Phase 3COMPLETED

Sponsor

AstraZeneca

Teilnehmer

694

Beginn

2003

Primärer Endpunkt

Time to disease progression (TTP)

Locally Advanced Breast CancerMetastatic Breast Cancer

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

NCT02028507Phase 3COMPLETED

Sponsor

Spanish Breast Cancer Research Group

Teilnehmer

693

Beginn

2014

Primärer Endpunkt

Progression-Free Survival (PFS)

Metastatic Breast Cancer

Study of Exemestane After Anastrozole or Letrozole Treatment of Postmenopausal Women With Hormone Responsive Breast Cancer

NCT00902954Phase 3UNKNOWN

Sponsor

Fudan University

Teilnehmer

540

Beginn

2008

Primärer Endpunkt

disease free survival

Breast Cancer

Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

NCT07061717Phase 3NOT_YET_RECRUITING

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Teilnehmer

474

Beginn

2025

Primärer Endpunkt

Progression-Free Survival (PFS) as Assessed by the Investigator

Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

NCT07062965Phase 3RECRUITING

Sponsor

Pfizer

Teilnehmer

400

Beginn

2025

Primärer Endpunkt

Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Breast Cancer

Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

NCT03538171Phase 3UNKNOWN

Sponsor

Taizhou EOC Pharma Co., Ltd.

Teilnehmer

375

Beginn

2018

Primärer Endpunkt

PFS (The Randomized Double-blinded Part)

Advanced Breast Cancer

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

NCT05306340Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Genentech, Inc.

Teilnehmer

373

Beginn

2022

Primärer Endpunkt

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer

Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02482753Phase 3COMPLETED

Sponsor

Chipscreen Biosciences, Ltd.

Teilnehmer

365

Beginn

2015

Primärer Endpunkt

progression-free survival (PFS), double-blinded period

Breast Cancer

Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

NCT00002777Phase 3COMPLETED

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Teilnehmer

342

Beginn

1996

Breast Cancer

4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer

NCT01626222Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

301

Beginn

2012

Primärer Endpunkt

Overall Response Rate (ORR) after 24 weeks of treatment

Metastatic Breast Cancer

A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

NCT03137368Phase 3UNKNOWN

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Teilnehmer

300

Beginn

2018

Primärer Endpunkt

Disease free survival (DFS)

CYP2D6 Polymorphism

Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

NCT00143390Phase 3COMPLETED

Sponsor

Pfizer

Teilnehmer

298

Beginn

2005

Primärer Endpunkt

Time to Progression (TTP) - Expert Evaluation Committee Assessment

Breast Neoplasms

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

NCT07024173Phase 3RECRUITING

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Teilnehmer

240

Beginn

2025

Primärer Endpunkt

Progression free survival (PFS) evaluated by the blinded independent central review (BICR).

Locally Advanced Breast CancerMetastatic Breast Cancer

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT03176238Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

235

Beginn

2013

Primärer Endpunkt

Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades

Post Menopausal Breast Cancer

PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

NCT04584853Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Institute of Cancer Research, United Kingdom

Teilnehmer

123

Beginn

2020

Primärer Endpunkt

Time to tumour (local or distant disease) recurrence

Breast Cancer Female

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

NCT02995772Phase 3COMPLETED

Sponsor

Dharmais National Cancer Center Hospital

Teilnehmer

122

Beginn

2011

Primärer Endpunkt

Overall survival

Breast Cancer

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

NCT01303679Phase 3TERMINATED

Sponsor

ARCAGY/ GINECO GROUP

Teilnehmer

117

Beginn

2010

Primärer Endpunkt

Primary free survival

First Line Metastatic Breast Cancer

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

NCT00659373Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Teilnehmer

Beginn

2007

Primärer Endpunkt

Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)

Breast CancerFatigueSleep Disorders

Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

NCT01237327Phase 3COMPLETED

Sponsor

Pfizer

Teilnehmer

Beginn

2001

Primärer Endpunkt

Overall Survival

Metastatic Breast Cancer

Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

NCT04869943Phase 3TERMINATED

Sponsor

Veru Inc.

Teilnehmer

Beginn

2021

Primärer Endpunkt

To demonstrate the efficacy of Enobosarm in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

Metastatic Breast Cancer

Premenopausal Endocrine Responsive Chemotherapy Trial

NCT00066807Phase 3TERMINATED

Sponsor

ETOP IBCSG Partners Foundation

Teilnehmer

Beginn

2003

Primärer Endpunkt

Disease-free Survival

Breast Cancer

Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

NCT00944918Phase 3COMPLETED

Sponsor

AstraZeneca

Teilnehmer

Beginn

2008

Primärer Endpunkt

Progression-free survival

Progression-free Survival

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

NCT05065411Phase 3TERMINATED

Sponsor

Veru Inc.

Teilnehmer

Beginn

2022

Primärer Endpunkt

Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria

Metastatic Breast Cancer

Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

NCT05253066Phase 2/3UNKNOWN

Sponsor

Shengjing Hospital

Teilnehmer

130

Beginn

2022

Primärer Endpunkt

ORR

Breast Neoplasms

Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

NCT06009627Phase 2/3COMPLETED

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Teilnehmer

119

Beginn

2023

Primärer Endpunkt

Objective response rate (ORR) for treatment

Breast Cancer

Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

NCT00684216Phase 2/3TERMINATED

Sponsor

The Netherlands Cancer Institute

Teilnehmer

Beginn

2008

Primärer Endpunkt

Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30

Breast Cancer

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

NCT04059484Phase 2TERMINATED

Sponsor

Sanofi

Teilnehmer

367

Beginn

2019

Primärer Endpunkt

Progression Free Survival (PFS)

Breast Cancer Metastatic

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

NCT06105632Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Pfizer

Teilnehmer

333

Beginn

2024

Primärer Endpunkt

Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Advanced or Metastatic Breast Cancer

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

NCT07179939Phase 2NOT_YET_RECRUITING

Sponsor

Fudan University

Teilnehmer

288

Beginn

2025

Primärer Endpunkt

PFS

HER2-positive Breast Cancer

Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients

NCT03272477Phase 2COMPLETED

Sponsor

Palleos Healthcare GmbH

Teilnehmer

257

Beginn

2017

Primärer Endpunkt

Pathological complete response (pCR)

Breast Neoplasms

Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02007512Phase 2COMPLETED

Sponsor

Pfizer

Teilnehmer

247

Beginn

2013

Primärer Endpunkt

Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)

Breast Cancer

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

NCT02676986Phase 2COMPLETED

Sponsor

Queen Mary University of London

Teilnehmer

221

Beginn

2015

Primärer Endpunkt

Determine the difference in geometric mean change in Ki67 expression between the two treatment groups of patients in the ER+ Cohort

Primary Breast Cancer ER+vePrimary Breast Cancer AR+ve TNBN

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

NCT01698918Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

202

Beginn

2013

Primärer Endpunkt

First-line Treatment: Progression-free Survival (PFS)

Hormone Receptor Positive Breast Cancer

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

NCT07101159Phase 2NOT_YET_RECRUITING

Sponsor

Fujian Cancer Hospital

Teilnehmer

200

Beginn

2025

Primärer Endpunkt

3-years Invasive Disease-Free Survival (iDFS)

Early Breast CancerAdjuvant TherapyHormone Receptor Positive / HER2-negative Breast Cancer

A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC

NCT02592746Phase 2UNKNOWN

Sponsor

Samsung Medical Center

Teilnehmer

182

Beginn

2016

Primärer Endpunkt

Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine

Metastatic Breast Cancer

Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer

NCT02598557Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Teilnehmer

180

Beginn

2016

Primärer Endpunkt

Percent Change in Time of Circulating Estradiol SPE in Each Arm

Stage 0 Breast Cancer AJCC v6 and v7Stage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

NCT03312738Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

159

Beginn

2017

Primärer Endpunkt

Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment

Advanced Breast Cancer

Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients

NCT02646735Phase 2UNKNOWN

Sponsor

Chinese Academy of Medical Sciences

Teilnehmer

148

Beginn

2015

Primärer Endpunkt

PFS

Breast Cancer

Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer

NCT07499999Phase 2NOT_YET_RECRUITING

Sponsor

Dana-Farber Cancer Institute

Teilnehmer

140

Beginn

2026

Primärer Endpunkt

Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months

Breast CancerDuctal CarcinomaEstrogen-receptor-positive Breast CancerAtypical Lobular HyperplasiaBRCA2 MutationCHEK2 Gene MutationAtaxia Telangiectasia Mutated Gene Mutation

Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT03291886Phase 2COMPLETED

Sponsor

Kyowa Kirin Co., Ltd.

Teilnehmer

133

Beginn

2017

Primärer Endpunkt

Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1)

Advanced or Recurrent Breast Cancer

Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

NCT00676663Phase 2COMPLETED

Sponsor

Syndax Pharmaceuticals

Teilnehmer

130

Beginn

2008

Primärer Endpunkt

Progression-free Survival (PFS)

Breast CancerEstrogen Receptor-Positive Breast CancerBreast Cancer, Estrogen Receptor-PositiveER+ Breast Cancer

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

NCT06428396Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Merck Sharp & Dohme LLC

Teilnehmer

120

Beginn

2024

Primärer Endpunkt

Progression-free Survival (PFS)

Metastatic Breast Cancer

Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer

NCT02049957Phase 2COMPLETED

Sponsor

Calithera Biosciences, Inc

Teilnehmer

118

Beginn

2014

Primärer Endpunkt

Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Breast Cancer

A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)

NCT01234857Phase 2COMPLETED

Sponsor

Merck Sharp & Dohme LLC

Teilnehmer

115

Beginn

2010

Primärer Endpunkt

Progression free survival (PFS)

Breast Cancer

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

NCT02549430Phase 2COMPLETED

Sponsor

Fondazione Sandro Pitigliani

Teilnehmer

115

Beginn

2012

Primärer Endpunkt

Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit)

Breast Cancer

Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer

NCT00674557Phase 2TERMINATED

Sponsor

Cancer Research UK

Teilnehmer

111

Beginn

2008

Primärer Endpunkt

Progression-free survival

Breast Cancer

Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

NCT00038103Phase 2COMPLETED

Sponsor

Pfizer

Teilnehmer

111

Beginn

2002

Primärer Endpunkt

Number of Subjects With Clinical Benefit

Breast Neoplasms

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

NCT00040014Phase 2TERMINATED

Sponsor

Pfizer

Teilnehmer

100

Beginn

2002

Primärer Endpunkt

To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.

Breast Neoplasms

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

NCT02069093Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

Beginn

2014

Primärer Endpunkt

Number of Participants With Stomatitis Grade ≥ 2

Advanced Breast Cancer

An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer

NCT07299890Phase 2NOT_YET_RECRUITING

Sponsor

Anhui Provincial Cancer Hospital

Teilnehmer

Beginn

2025

Primärer Endpunkt

tpCR rate，total physiological complex response

Breast Cancer

Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

NCT05472792Phase 2RECRUITING

Sponsor

UNC Lineberger Comprehensive Cancer Center

Teilnehmer

Beginn

2022

Primärer Endpunkt

Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Breast CancerQuality of Life

A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)

NCT01605396Phase 2COMPLETED

Sponsor

Merck Sharp & Dohme LLC

Teilnehmer

Beginn

2012

Primärer Endpunkt

1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)

Breast Neoplasms

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

NCT04300790Phase 2COMPLETED

Sponsor

MedSIR

Teilnehmer

Beginn

2020

Primärer Endpunkt

Assess the rate of patients with G3-4 hyperglycemia (HG) by CTCAE v4.03 over the first 2 cycles of treatment with alpelisib (BYL719) (Cohorts A and B)

Breast Cancer

Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

NCT04858516Phase 2UNKNOWN

Sponsor

Guangdong Provincial People's Hospital

Teilnehmer

Beginn

2021

Primärer Endpunkt

pathological complete response(ypT0/is,ypN0, pCR)

Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

NCT03555877Phase 2COMPLETED

Sponsor

GBG Forschungs GmbH

Teilnehmer

Beginn

2018

Primärer Endpunkt

Locally-assessed progression-free survival (PFS)

Breast Cancer Metastatic

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

NCT02028364Phase 2COMPLETED

Sponsor

Jules Bordet Institute

Teilnehmer

Beginn

2014

Primärer Endpunkt

PFS based on RECIST criteria 1.1.

Breast Cancer

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

NCT02476786Phase 2RECRUITING

Sponsor

Washington University School of Medicine

Teilnehmer

Beginn

2017

Primärer Endpunkt

Response rate

Breast CancerCancer of BreastBreast NeoplasmsCancer of the Breast

Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer

NCT00073073Phase 2COMPLETED

Sponsor

Georgetown University

Teilnehmer

Beginn

2003

Primärer Endpunkt

Percent Change in Mammographic Density at 1 Year on Exemestane

Breast Neoplasms

Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

NCT00174343Phase 2COMPLETED

Sponsor

Pfizer

Teilnehmer

Beginn

2001

Primärer Endpunkt

To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Breast Neoplasms

Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

NCT04659551Phase 2COMPLETED

Sponsor

Istituto Oncologico Veneto IRCCS

Teilnehmer

Beginn

2017

Primärer Endpunkt

pathological complete response (pCR)

Breast Cancer

Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

NCT03300557Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Teilnehmer

Beginn

2017

Primärer Endpunkt

Change in Tumor Proliferation

Atypical HyperplasiaEndometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaEndometrial CarcinomaFIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

NCT00201864Phase 2COMPLETED

Sponsor

Ohio State University Comprehensive Cancer Center

Teilnehmer

Beginn

2005

Primärer Endpunkt

Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.

Breast Cancer

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

NCT03691493Phase 2COMPLETED

Sponsor

Emory University

Teilnehmer

Beginn

2019

Primärer Endpunkt

Response Rate

Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu NegativeMetastatic Breast CarcinomaMetastatic Malignant Neoplasm in the BoneProgesterone Receptor PositivePrognostic Stage IV Breast Cancer AJCC v8

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

NCT01831076Phase 2COMPLETED

Sponsor

University of Colorado, Denver

Teilnehmer

Beginn

2002

Primärer Endpunkt

Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings

Breast CancerStage II Breast CancerStage III Breast Cancer

Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00810797Phase 2COMPLETED

Sponsor

City of Hope Medical Center

Teilnehmer

Beginn

2008

Primärer Endpunkt

Progression-free Survival

Breast Cancer

Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330Phase 2COMPLETED

Sponsor

Emory University

Teilnehmer

Beginn

2009

Primärer Endpunkt

Pathologic Complete Response

Breast Cancer

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

NCT04465097Phase 2COMPLETED

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Teilnehmer

Beginn

2020

Primärer Endpunkt

objective response rate (ORR) evaluated by MRI

Breast Cancer

Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer

NCT00261027Phase 2COMPLETED

Sponsor

Ottawa Hospital Research Institute

Teilnehmer

Beginn

2003

Primärer Endpunkt

response rate toxicities

Ovarian Cancer

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

NCT00194792Phase 2TERMINATED

Sponsor

University of Washington

Teilnehmer

Beginn

2005

Primärer Endpunkt

Number of Participants With Clinical Response

Estrogen Receptor-positive Breast CancerHER2-negative Breast CancerProgesterone Receptor-positive Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast Cancer

Exemestane-RAD001-Metformin

NCT01627067Phase 2TERMINATED

Sponsor

M.D. Anderson Cancer Center

Teilnehmer

Beginn

2012

Primärer Endpunkt

Progression-Free Survival (PFS)

Breast Cancer

Exemestane and Cyclophosphamide for Metastatic Breast Cancer

NCT01963481Phase 2COMPLETED

Sponsor

NYU Langone Health

Teilnehmer

Beginn

2013

Primärer Endpunkt

Progression-free Survival (PFS) Rate at 3 Months

Metastatic Beast Cancer

ER Reactivation Therapy for Breast Cancer

NCT02188745Phase 2COMPLETED

Sponsor

Dartmouth-Hitchcock Medical Center

Teilnehmer

Beginn

2016

Primärer Endpunkt

Clinical Benefit

Metastatic Breast Cancer

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

NCT03874325Phase 2TERMINATED

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Teilnehmer

Beginn

2019

Primärer Endpunkt

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0

Breast CancerHormone Receptor Positive Tumor

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

NCT06169124Phase 2ACTIVE_NOT_RECRUITING

Sponsor

National Cancer Institute (NCI)

Teilnehmer

Beginn

2024

Primärer Endpunkt

Objective response rate

Adult Ovarian Granulosa Cell Tumor

Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

NCT00919399Phase 2COMPLETED

Sponsor

Institut Claudius Regaud

Teilnehmer

Beginn

2002

Primärer Endpunkt

Evaluate the objective response rate (complete response and partial response)

Breast Neoplasms

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

NCT05150652Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Irada Ibrahim-zada

Teilnehmer

Beginn

2022

Primärer Endpunkt

Change in margin status

Breast CancerHER2-negative Breast CancerNode-negative Breast CancerBreast Carcinoma

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

NCT06630325Phase 2TERMINATED

Sponsor

OHSU Knight Cancer Institute

Teilnehmer

Beginn

2025

Primärer Endpunkt

Proportion of Participants Who Receive an ACT Therapy Based on a SMMART-ACT Tumor Board Recommendation.

Advanced Breast CarcinomaAdvanced Malignant Solid NeoplasmAdvanced Ovarian CarcinomaAdvanced Pancreatic CarcinomaAdvanced Prostate CarcinomaAdvanced SarcomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IV Prostate Cancer AJCC v8

Exemestane in Post-Menopausal Women With NSCLC

NCT02666105Phase 2COMPLETED

Sponsor

Masonic Cancer Center, University of Minnesota

Teilnehmer

Beginn

2018

Primärer Endpunkt

Disease Response (RECIST)

Non-Small Cell Lung Cancer

Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer

NCT00573755Phase 2TERMINATED

Sponsor

Mayo Clinic

Teilnehmer

Beginn

2007

Primärer Endpunkt

Progression-free Survival

Breast Cancer

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

NCT01202591Phase 1/2COMPLETED

Sponsor

AstraZeneca

Teilnehmer

127

Beginn

2010

Primärer Endpunkt

Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)

FGFR Inhibition, Pharmacokinetics, BiomarkersER+ Breast Cancer

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

NCT02732119Phase 1/2COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

104

Beginn

2016

Primärer Endpunkt

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I

Breast Cancer

Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

NCT05573126Phase 1/2RECRUITING

Sponsor

Ellipses Pharma

Teilnehmer

Beginn

2023

Primärer Endpunkt

Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment

Hormone Receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer

Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

NCT00905021Phase 1/2TERMINATED

Sponsor

Baylor Breast Care Center

Teilnehmer

Beginn

2010

Primärer Endpunkt

Time to Disease Progression in Weeks

Metastatic Breast Cancer

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705Phase 1RECRUITING

Sponsor

Eli Lilly and Company

Teilnehmer

260

Beginn

2022

Primärer Endpunkt

Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)

Breast Cancer

BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer

NCT02123823Phase 1COMPLETED

Sponsor

Boehringer Ingelheim

Teilnehmer

164

Beginn

2014

Primärer Endpunkt

Progression-free Survival (PFS) - Phase II Part

Neoplasms

Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

NCT01857193Phase 1COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

132

Beginn

2013

Primärer Endpunkt

Dose Escalation: Incidence of Dose Limiting Toxicity (DLT)

Breast Cancer

Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

NCT01597193Phase 1COMPLETED

Sponsor

Pfizer

Teilnehmer

101

Beginn

2012

Primärer Endpunkt

Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)

Breast Cancer

BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

NCT01938846Phase 1COMPLETED

Sponsor

Boehringer Ingelheim

Teilnehmer

Beginn

2013

Primärer Endpunkt

The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm

Neoplasms

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

NCT02077933Phase 1COMPLETED

Sponsor

Novartis Pharmaceuticals

Teilnehmer

Beginn

2014

Primärer Endpunkt

Dose escalation : Incidence of dose Limiting Toxicity (DLTs)

NeoplasmsBreast NeoplasmsKidney NeoplasmsPancreatic Neuroendocine Neoplasms (pNETs)

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

NCT02820961Phase 1COMPLETED

Sponsor

Syndax Pharmaceuticals

Teilnehmer

Beginn

2016

Primärer Endpunkt

Cmax, maximum plasma concentration

Breast CancerEstrogen Receptor Positive Breast Cancer

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

NCT03308201Phase 1COMPLETED

Sponsor

Tianjin Hemay Pharmaceutical Co., Ltd

Teilnehmer

Beginn

2017

Primärer Endpunkt

Number of participants with adverse events

Breast Cancer

A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

NCT04572295Phase 1COMPLETED

Sponsor

Eisai Co., Ltd.

Teilnehmer

Beginn

2020

Primärer Endpunkt

Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer Agents

Breast Neoplasms

E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study

NCT07706374Phase 1NOT_YET_RECRUITING

Sponsor

University of North Carolina, Chapel Hill

Teilnehmer

Beginn

2026

Primärer Endpunkt

Number of participants with study-defined positive progesterone levels on Day 21

Poly Cystic Ovary Syndrome

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer

NCT02392611Phase 1COMPLETED

Sponsor

Gilead Sciences

Teilnehmer

Beginn

2015

Primärer Endpunkt

Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Solid Tumors and Lymphomas

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

NCT03554044Phase 1COMPLETED

Sponsor

University of California, San Francisco

Teilnehmer

Beginn

2020

Primärer Endpunkt

Number of patients with treatment-related toxicities by maximum observed grade

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu NegativeInvasive Breast CarcinomaPrognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Recurrent Breast Carcinoma

Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

NCT02833155Phase 1COMPLETED

Sponsor

Taizhou EOC Pharma Co., Ltd.

Teilnehmer

Beginn

2016

Primärer Endpunkt

Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination.

Breast Cancer

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT02623751Phase 1COMPLETED

Sponsor

Kyowa Kirin Co., Ltd.

Teilnehmer

Beginn

2015

Primärer Endpunkt

Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events

Breast Cancer

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

NCT01594398Phase 1COMPLETED

Sponsor

Syndax Pharmaceuticals

Teilnehmer

Beginn

2012

Primärer Endpunkt

Difference in pharmacokinetics of entinostat when subjects fed or fasted

Lung CancerNon Small Cell Lung Cancer (NSCLC)Breast CancerEstrogen Receptor Breast Cancer

Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

NCT01664754Phase 1COMPLETED

Sponsor

Jonsson Comprehensive Cancer Center

Teilnehmer

Beginn

2012

Primärer Endpunkt

Tabulation, grading, and attribution of serious adverse events (SAEs) and adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Stage IV Non-small Cell Lung Cancer

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