Letrozole

Time to all-cause mortality (overall survival)

Live birth rate

Live birth

Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method

Overall Survival (OS)

Ongoing pregnancy rate

ongoing pregnancy rate

Live-birth rate

Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups

Incidence of bleeding

occurrence of ovulation and midcycle endometrial thickness (mm).

Progression-free survival(PFS)

Progression free survival(PFS) of the subjects

live birth rate

Clinical pregnancy rates

Recurrence of endometrioma

the endometrial thickness

Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.

Clinical pregnancy rate per cycle

Clinical Pregnancy Rate

Number of participants with successful ovulation

Clinical Pregnancy Rate

determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .

Knee Cartilage Volume

ongoing pregnancy

Ovulation Rate

Miscarriage Achievement

Rate of complete abortion

Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)

Ovulation rate

Decrease in β-hCG levels

Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer

To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.

endometrial abv3-integrin expression expressions

Progression Free Survival

Change in Proliferative response

Blood loss during the procedure expressed as a decrease in hemoglobin concentration

Letrozole : AUC0-tz

Ovulation rate

Change in Insulin Receptor Substrate 1 (IRS-1) / Phosphoinositide 3-kinase (PI3K) / Serine-threonine Protein Kinase (AKT) Pathway Activation

Correlation between pharmacokinetic and pharmacogenetic parameters

DQoL

Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.

Number of Participants With Treatment-Emergent Adverse Events (All Causalities)

ongoing pregnancy rate.

complete abortion rate

the number of asynchronized follicles in both groups

Ovulation

Ongoing pregnancy rate

Rate of complete abortion by Day 21-28

Time-to-treatment failure (TTF)

Safety and tolerability of Letrozole

Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

Changes in Ki67

normal follicular size

fate of the dominant follicle or luteal structure

Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)

cardiac function parameters

Operative time

Number of Participants With Progesterone Level Greater Than 1.5 ng/mL

Change in plasma total testosterone concentration after 24 weeks from baseline

Disease-free Survival (DFS)

Invasive breast cancer-free survival (IBCFS)

Disease-free Survival

Invasive Disease-Free Survival (IDFS)

5-years Invasive disease free survival

disease free survival in premenopausal patients

Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator

Progression Free Survival (PFS)

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.

Progression Free Survival (PFS) by BICR

Patient reported outcome measures (PROM) HRQoL as assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Progression-Free Survival (Arm 1 vs arm 2)

Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment

Progression Free Survival (PFS)

Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)

Progression-free survival (PFS)

PFS is determined by IRC

Progression-free survival

Disease free survival

Progression-free survival

Live birth rate

Progression-free Survival (PFS)

Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)

Progression Free Survival (PFS)

Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change

Progression Free Survival (PFS) per blinded independent central review (BICR)

Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)

The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

objective response rate (ORR)

Progression-free survival (PFS)

Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate

Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)

To determine ovarian volume in millilitres in oocyte donors according to whether or not they receive the treatment during the luteal phase after ovarian stimulation.

The primary outcome is cumulative ovulation rate

Progression-free survival (PFS)

effective rate

ovulation rate

ovulation

Proportion of patient alive at 12 months

The number of participants having mature follicle (mean diameter ≥18mm)

Body weight

Sperm density

Duration of induction of abortion

The complete response rate (CRR) at 32 weeks after initiating treatment.

pathological complete remission rate

(β-hCG) level

Sperm concentration (×10⁶/mL) after 3 months of treatment

Osteocalcin level

testicular volume

Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event

Complete response rates within 28 weeks of treatment

Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression

the 3-year Progression-Free-Survival(PFS)

Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

3-year invasive disease-free survival

1-year Progression Free Survival

Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months

Number of participants with dose-limiting toxicities in the Dose Escalation Arms.

Measurement of the Proliferation Marker Ki67 (% Positive Tumor Cells)

Progression-Free Survival (PFS) - All Cohorts

Progression-Free Survival (PFS) Assessed by Investigator

Pathologic Complete Response Rate (tpCR: ypT0-is/ypN0)

Progression-free Survival

6 months Progression free survival rate

Geometric mean suppression of proliferation marker Ki67

Recurrence Free Survival (RFS)

Determination of change in tumour proliferation measured by Ki67 immunohistochemical (IHC) assessment (%) at baseline compared to Day 15 (+ ≤4 days).

Clinical response at 24 weeks

Progression Free Survival (PFS)

Confirmed Objective Response Rate (ORR)

Time to failure of strategy (TFS)

Sub-cutaneous late toxicity

Progression free survival (PFS)

Clinical pregnancy rate per started cycle

The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days)

Clinical benefit rate.

Extent of Axillary Nodal Pathologic Complete Response (pCR)

Conversion Rate

Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm.

Percentage of Participants With Complete Cell Cycle Arrest (CCCA) at Day 14

Rate of pCRBL (ypT0/is ypN0) at surgery

Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population

Progression - Free Survival (PFS)

pathologic complete remission (pCR)

Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)

Complete response rates within 16 weeks of treatment

Progression free survival (PFS) will be measured

Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness

Incidence of AEs and SAEs

1. The proportion of (PEPI score 0 + pCR) in patients with discordant EPclin scores and Ki67 assessments who were randomly assigned to the "+CDK4/6i" group

Progression-Free Survival (PFS)

Incidence of Adverse Events

Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks)

Clinical Benefit rate (CBR)

To study the change in levels of direct and indirect immunologic biomarkers of targeted cancer therapy with letrozole and ribociclib given in combination for patients with locally-advanced, ER-positive, HER-2 negative, luminal A7B breast cancer

Objective Response Rate (ORR)

The Percentage of Participants With Pathologic Complete Response

The seminal fluid analysis

Frequency of Response

Pathological Complete Response

pathologic complete response

Clinical benefit response rate (complete response, partial response, or stable disease for > 24 weeks)

Overall response rate

Difference on Recurrence Score between pre and post-treatment (molecular results)

Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.

Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1

Percentage of Participants with Adverse Events (AEs)

Response to abemaciclib + endocrine therapy

Objective Response Rate (ORR)

Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months

Progression-free survival

Objective Response Rate (ORR)

Time to Optimal Ovarian Function Suppression

Number of Patients With Pathological Complete Response.

Progression Free Survival (PFS)

Safety

Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.

Objective Response Rate (ORR) per RECIST version 1.1

Progression Free Survival

Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks

Feasibility of the trial

Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.

Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Breast Pathological Complete Response Rate (bpCR)

To determine the proportion of patients with ER and/or PR positive, ErbB2 positive tamoxifen resistant metastatic breast cancer who achieve complete remission (CR)

Median Progression Free Survival (PFS)

pathologic complete response

ORR

The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole.

Number of Participants With Pathologic Complete Response (pCR)

Length of luteal phase (days from aspiration untill bleeding)

To determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR

Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month

Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.

Safety during treatment

Objective Response Rate Following Treatment With Letrozole

Cell Cycle Response Rate Per Cell Proliferation Marker Ki67

Objective response rate as assessed by CT scan or MRI every 3 months

Total pathological complete response (tpCR)

Clinical Benefit Rate of Patients Treated With the Combination of Letrozole and Lapatinib and Then After Progression, Treated With Everolimus, Letrozole and Lapatinib.

Objective Tumor Response (Part 2)

Progression-free Survival (PFS)

Assess the effect of the combination of letrozole & PTK787/ZK222584 on disease progression.

Response Rate (Partial Response Plus Complete Response) Using RECIST

Alveolar-Arterial Oxygen

Overall response rate as measured by RECIST

Objective Response Rate (ORR)

Number of participants who experience at least 1 Dose Limiting Toxicity (DLT)

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)

Single agent and combination dose exploration study：AE evaluation

Incidence of Dose limiting toxicities (DLTs) - Phase lb only

Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Dose-limiting toxicity (DLT)

pregnancy rate

Progression free survival

Dose-limiting toxicity (DLT)

Safety and tolerability of XL147 and letrozole and XL765 and letrozole

Dose limiting toxicities (DLTs) will be tabulated and summarized by cohort

Insulin Sensitivity Quantified by Matsuda Index

Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)

Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both

FSH Level

Dose Limiting Toxicities (DLT)

Number of Participants with One or More Drug-Related Adverse Events

Incidence and severity of dose-limiting toxicities (DLTs)

Number of participants with dose limiting toxicities

[Cohort A, B, C & D] Maximum Tolerated Dose (MTD) of Xentuzumab

Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau)

MTD

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Phase II Dose of BYL719/Alpelisib (Arm A and Arm B)

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.

Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)

To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.

DLT

ovulation rate

Changes in the expression of the PAM50 proliferation signature upon treatment in patients defined as Luminal by PAM50

Mean percentage change in Ki-67

Patients who complete the dietary intervention

Changes in the expression of biomarkers

To evaluate if pelareorep in combination with different therapies increases the value of the CelTIL score in women with operable early breast cancer. CelTIL is a combined IHC-based score based on tumor cellularity and stromal TILs.

Nicotine area under the concentration vs. time curve (AUC) ratio (exposure/baseline)