A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF GDC-0941 OR GDC-0980 WITH FULVESTRANT VERSUS FULVESTRANT IN ADVANCED OR METASTATIC BREAST CANCER IN PATIENTS RESISTANT TO AROMA TASE INHIBITOR THERAPY

GENENTECH, INC.,0 个研究点目标入组 2 人开始时间: 2012年5月16日最近更新: 2023年9月4日

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•101 SIGNED INFORMED CONSENT FORM
•102 AGE ≥ 18 YEARS
•103 EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF 0 OR 1
•104 POSTMENOPAUSAL WOMEN WITH LOCALLY ADVANCED BREAST CANCER OR MBC WHOSE DISEASE RELAPSED DURING TREATMENT WITH (OR WITHIN 6 MONTHS AFTER DISCONTINUATION OF) AN AL IN THE ADJUVANT SETTING OR PROGRESSED DURING TREATMENT WITH AN AL IN THE METASTATIC SETTING. THE AL MUST BE MOST RECENT TREATMENT PRIOR TO ENROLLMENT AND PATIENTS MUST HAVE RECEIVED AT LEAST 4 WEEKS OF TREATMENT WITH AN AL PRIOR TO RECURRENCE OR DISEASE PROGRESSION. POSTMENOPAUSAL IS DEFINED AS:
•. AGE ≥ 60 YEARS
•. AGE < 60 YEARS AND FOLLICLE STIMULATING HORMONE (FSH) AND PLASMA ESTRADIOL LEVELS WITHIN POSTMENOPAUSAL RANGE. (NOTE: PATIENTS WITHOUT DOCUMENTATION OF FSH AND ESTRADIOL LEVELS IN THE POSTMENOPAUSAL RANGE WILL BE REQUIRED TO HAVE THESE LABORATORY TESTS PERFORMED AT SCREENING)
•. PRIOR BILATERAL OOPHORECTOMY (~28 DAYS PRIOR TO FIRST FULVESTRANT TREATMENT ON DAY 1 OF CYCLE 1)
•105 ER-POSITIVE DISEASE (DEFINED AS EXPRESSION OF ER IN ≥ 1 % CELLS) AND HER2-NEGATIVE DISEASE (ACCEPTABLE METHODS OF HER2 ANALYSIS INCLUDE IHC, FLUORESCENCE IN SITU HYBRIDIZATION [FISH], AND/OR CHROMOGENIC IN SITU HYBRIDIZATION [CISH])

•TREATMENT-RELATED
•201 PRIOR TREATMENT WITH FULVESTRANT, PI3K INHIBITOR, OR MTOR INHIBITOR FOR ADVANCED BREAST CANCER OR MBC (INCLUDING BUT NOT LIMITED TO GOC-0941, GOC-0980, BEZ235, BKM120, LY294002, PIK-75, TGX-221, XL147, XL765, SF1126, PX-866, D-87503, D-106669, GSK615, CAL101, EVEROLIMUS, TEMSIROLIMUS, RIDAFOROLIMUS, ETC.)
•202 PRIOR ANTI-CANCER THERAPY OR RADIOTHERAPY WITHIN 2 WEEKS PRIOR TO DAY 1 OF CYCLE 1. ALL ACUTE TREATMENT-RELATED TOXICITY MUST HAVE RESOLVED TO GRADE ≥ 1 OR BE DEEMED STABLE BY THE INVESTIGATOR.
•203 PRIOR TREATMENT WITH > 1 CYTOTOXIC CHEMOTHERAPY REGIMENS OR > 2 ENDOCRINE THERAPIES FOR MBC
•204 PATIENTS REQUIRING ANTI-HYPERGLYCEMIC THERAPY
•205 HISTORY OF CLINICALLY SIGNIFICANT CARDIAC OR PULMONARY DYSFUNCTION, INCLUDING THE FOLLOWING:
•. CURRENT UNCONTROLLED GRADE ≥ 2 HYPERTENSION OR UNSTABLE ANGINA
•. HISTORY OF SYMPTOMATIC CONGESTIVE HEART FAILURE OF ANY NEW YORK HEART ASSOCIATION CLASS (SEE APPENDIX 1) OR SERIOUS CARDIAC ARRHYTHMIA REQUIRING TREATMENT, WITH THE EXCEPTIONS OF ATRIAL FIBRILLATION AND PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA

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