Anastrozole

Overall Survival According to Unadjusted Analysis

disease free survival

Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period

Endothelial function

Progression of disease and tolerability in general

To measure 24-hour CPR, free cortisol, and cortisol binding globulin levels in plasma; HSD 1 activity, glucocorticoid receptor binding, and cortisol levels in adipocytes; and urinary excretion of cortisol, cortisone and their metabolites.

the suppression proportion of serum estradiol (E2)

Overall adherence to anastrozole

Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level

Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections

Expression of progesterone

Cerebral blood flow responses to estrogen and testosterone

Percent Change in Proliferative Index (Ki67) After Treatment With the Standard Dose Anastrozole or Letrozole in Normal, Obese, and Overweight Patients

Progression-free survival (PFS)

bioequivalence determined by statistical comparison Cmax

The rate of success in each of the two groups, evaluated using an X-ray of the left hand and wrist. Success is defined as a difference in the rate of progression of bone maturation of at least 9 months after 18 months of treatment.

Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery

Incidence of Fatty Liver Disease

pregnancy after embryo transfer

The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)

Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event

Number of Participants With New Events of Arthralgia

Local failure within irradiation volume

Cerebral Blow Flow (CBF): Hormone Suppression Hypoxia Condition

size of endometriomas after 2½ month of combined downregulation

1. Tolerability(safety) 2.Efficacy (a) Time to tumor progression TTP (b) Objective Response (OR) Rate (c) Symptom Evaluation

Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole

Time to recurrence of breast cancer

Invasive breast cancer-free survival (IBCFS)

Invasive Disease-Free Survival (IDFS)

Time to recurrence

Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years

To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Disease-free Survival After Prolonged Endocrine Treatment

Time to First Clinical Fracture

To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.

To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

Rate of endocrine resistant disease-(First Phase)

Disease Free Survival (DFS) Events

Progression-Free Survival (Arm 1 vs arm 2)

Progression-free Survival

Time to Tumor Progression

Clinical Response (Complete or Partial Response) Rate (Cohort A)

Progression-free Survival (PFS) as Assessed by Investigator

Time to Progression (TTP)

Dose-Selection Part: Incidence of adverse events

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

Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole

3-year invasive disease-free survival

Investigator-assessed PFS

Investigator-assessed progression free survival (PFS)

Progression Free Survival (PFS) Events in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI)

Time to withdrawal

Number of Participants with Adverse Events

Progress-free survival

Time to Disease Progression (TTP)

Distant metastasis free survival (DMFS)

Level of TGF-β1

Progression Free Survival (PFS)

Progression free survival

progression-free survival (PFS)

Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test

Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus )

Pregnancy Rate

Evaluation of the disease free survival

Change in linear dimensions of the breast

The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.

Local tumor control (invasive and in situ local recurrence)

Distant relapse-free interval (DRFI)

Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Overall Response Rate (ORR)

Pre and Postmenopausal Cohorts: Progressive Free Survival (PFS) Based on Local Assessment by RECIST 1.1 Guideline

Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD

Progression Free Survival (PFS)

Progression-Free Survival (PFS)

Progression-Free Survival (PFS)

Change in Ki 67

Progression-free Survival

Clinical Benefit Rate

Progression Free Survival

the efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)

2-Year Treatment Discontinuation Rate

Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies

Clinical Benefit Rate

Time to Progression (TTP)

Progress-free survival

Objective Response Rate (ORR) Determined by Clinical Palpation

Clinical tumor response as assessed by RECIST criteria

Treatment feasibility

adverse events

Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0

Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors.

Change in Lean Body Mass

Change in Six-minute Walk Distance

Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)

Rate of participants achieving Residual Cancer Burden (RCB) grade 0 or 1

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Progression-Free Survival (PFS)

Responders

Progression-free survival at 1 year

The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy

Endometrial thickness as measured by transvaginal ultrasound, safety

Change in Ki-67

clinical benefit rate（CBR）

Determine the feasibility and efficacy of the combination of these 2 drugs in these patients

Fold Change in Expression Profile of Genes and/or Proteins for Arm A (LAP+TRAS±AI (HER2-Enriched)) From Screening to Approx. 3.5 Years

Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.

Progression free survival

ORR

Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy

Objective Response Rate (ORR)

Overall Response Rate

Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole)

Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment

Number of Participants With Overall Response

Number of Participants With Adverse Events

Clinical Benefit Rate (CBR)

The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase

Plasma Estradiol (E2) Level

Pathological Complete Response Rate

Progression Free Survival

Clinical and Radiological Response

Evidence of Pathological Response

Time to disease progression

Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)

Overall Response Rate (ORR) in Patients

Tumor Objective Response by MRI

Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

Number of patients with severe toxicities occurring during the first 8 weeks of follow-up assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) V4

Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole

Number of Participants With Serious Adverse Events (SAEs)

The number of subjects with dose-limiting toxicity, as defined in the protocol.

Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

Occurrence of adverse events (AEs)- Part 1

Insulin sensitivity

Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups

Immunogenicity (of MUC1 vaccine)

To determine whether short term exposure to endocrine therapy (anastrozole) induces changes in gene expression in human invasive breast cancer.

BioStatistical Analysis

Number of treatment emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Bioavailability based on Cmax and AUC parameters

MTD of Akt inhibitor MK-2206 in combination with anastrozole determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) (Phase IA)

the ratios of geometrical mean

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

testosterone Cmax