Tamoxifen

Incidence of invasive breast cancer and breast cancer-free interval

Disease-free survival(DFS)

pathological complete remission rate

Correlations between antiestrogen hormone therapy and brain function & structure

Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites

Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment

Estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer.

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

Percent change in plasma concentrations of 4-hydroxy tamoxifen and of endoxifen after ≥ 8 weeks of concurrent administration of tamoxifen citrate and a CYP2D6 inhibitor

Change in endometrial thickness

The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment

Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm

Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)

The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients

Percentage of participants with treatment-emergent adverse events (AES)

endometrium thickness

Number of Bleeding and Spotting Days

All-cause mortality

Overall survival (i.e., all-cause mortality)

Duration of DFS

Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone.

Invasive Disease-Free Survival (IDFS)

Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group

Pathological locoregional complete tumor response (pCR) between both arms

Time to progression

Breast tumor recurrence

Disease-free Survival

Disease-free survival of patients

Relapse-free survival

Disease-Free Survival (DFS)

DFS

Ipsilateral Breast Tumor Recurrence (IBTR)

Local recurrence (e.g., invasive or noninvasive recurrence)

Disease-free survival

Mastalgia clinical response rate

Comparison of time to progression

Median number of positive axillary lymph nodes

Disease-free survival.

Time to withdrawal

Development of Lung fibrosis

Suppression of ovarian function

Overall Survival

Quality-adjusted survival

In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm

Best Overall Response Rate (BORR) (Calliper)

Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.

Cytokeratin 5 (CK5)-expression

Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules

Median Progression-free Survival

Quality of Life

Estradiol blood concentation

survival outcomes: disease free survival

Progression-free Survival (PFS)

disease free survival

Mammograpic Density Change

Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.

Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes

Evaluate the rate of pCR

Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)

Decrease in tumor cell proliferation and induced apoptosis.

Low Dose Tamoxifen

Progression Free Survival (PFS)

Percentage of patients who have a log linear rise in CA 125 levels

lung injury score

Median Progression-Free Survival

Quality of life MEnQol

Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months

Progression-free Survival by CYP2D6 Status in 2 Categories

Change in number of daily hot flushes at 3 months from baseline

Semen Volume

Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.

Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength

Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing

Normal Testosterone Recovery

To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC

Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer

Mammographic Breast Density

Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment

Endocrine Therapy response

Progression-free survival

Percentage of Patients Failure Free at 2 Years Following Study Entry

Change in serum adiponectin

Change in Median Lobular Ki67 From Pre-Tamoxifen Breast Biopsy to On-Tamoxifen Biopsy With 4 Weeks of Intervention

Change in ALS Functional Rating Scale - Revised (ALSFRS-R)

Treatment-Emergent Adverse Events [Safety and Tolerability])

3 month progression-free survival

Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer

Scores on CARS-M Scale at trial completion

Disease-free survival

Event-free Survival

Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)

Toxicity profile as assessed by NCI CTC v2.0

Progression free survival (PFS)-rate in the full population, after 6 months

Response rate by CA-125

The response rate

To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment

Objective Response Rate (ORR)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility

Progression-free survival (PFSn)

Ki67 Expression

Disease control rate

Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Number of Patients With Pathological Complete Response

Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion

To define the efficacy (progression-free survival rate at 6 months) of LY2228820 in combination with tamoxifen for postmenopausal women with an ER positive and HER2 negative advanced or metastatic breast cancer who progressed on aromatase inhibitors.

cellular response

Ki67 in breast tissue of enrolled patients

Changes in Markers of Proliferation Prior to and After Study Drug Administration

Overall Response Rate (ORR)

Safety and tolerability

Stage 1: Percentage of Participants With Objective Response

Number of Subjects With Treatment Emergent Adverse Events

Endoxifen blood concentration

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991

Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.

Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination

A change in Ki67 expression following tamoxifen therapy, by comparing the pre- and post- tamoxifen biopsies

6-minute walk distance (6MWD)

Recommended Phase II Dose (RP2D)

Change in Ki67 Cell Percentage

Progression-free Survival (PFS)