None listed
Conditions
Interventions
THE STUDY IS DESIGNED TO ESTIMATE THE EFFECT OF THE ADDITION OF GDC-0941 TO FULVESTRANT (ARM A) AND OF GDC-0980 TO FULVESTRANT (ARM B) ON PFS COMPARED WITH FULVESTRANT+PLACEBO (ARM C). THESE TWO COMPA
Sponsors
GENENTECH, INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • 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])
Exclusion criteria
Exclusion criteria: • 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 CLINICAL 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
Countries
Angola, Arabia Saudi, Armenia, Azerbaijan, Bahrain, Barbados, Bhutan, Brunei, Burkina Faso, Camboia, Congo, Congo Democratic Republic, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominica, Germany, Israel, Ivory Coast, Korea South, Malasya, New Zealand, United States
Outcome results
None listed