None listed
Conditions
Interventions
• Experimental: fulvestrant + alpelisib
Alpelisib (300 mg
once daily) in combination with fulvestrant (500 mg
intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Interventions:
o Drug: Fulvestrant
o Drug: Alpelisib
• Placebo Comparator: fulvestra
intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Interventions:
o Drug: Fulvestrant
o Drug: Alpelisib placebo
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. 2. Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. One tumor block (preferred) or 15 to 20 slides (15 slides minimum from a surgical specimen, 20 slides minimum from a biopsy) are requested. 3. Patient has identified PIK3CA status (mutant or non-mutant; determined by a Novartis designated laboratory on the FFPE sample or slides). 4. If female, then the patient is postmenopausal. Postmenopausal status is defined either by: •Prior bilateral oophorectomy •Age ≥60 •Age <60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and Follicle-stimulating Hormone (FSH) and estradiol in the postmenopausal range per local normal range. 5. Patient has radiological or objective evidence of recurrence or progression. 6. Patient has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory. The complete list of inclusion criteria is in section 5.2 of the protocol
Exclusion criteria
Exclusion criteria: 1. Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s best judgment. 2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor. 3. Patient has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant. 4. Patient with inflammatory breast cancer at screening. 5. Patient is concurrently using other anti-cancer therapy. 6. Patient has had surgery within 14 days prior to starting study drug or has not recovered from major side effects. 7. Patient has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: patients with any grade of alopecia are allowed to enter the study. 8. Patients with Child pugh score B or C. 9. Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 25% of the bone marrow was irradiated. The complete list of inclusion criteria is in section 5.3 of the protocol
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea South, Lebano, Mexico, Netherlands, Peru, Portugal, Romania, Russian Federation, Spain, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kindgdom, United States
Contacts
Public ContactJoel Sachun
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed