Hormone receptor positive, HER2-negative advanced breast cancer MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Alpelisib
Product Code: BYL719 50 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Alpelisib
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Other descriptive name:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is an adult = 18 years old at the time of informed consent 2. Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status 3. Patient has identified PIK3CA status 4. If female, then the patient is postmenopausal 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 7. Patient has HER2-negative breast cancer 8. Patient has either measurable disease (at least one measurable lesion as per RECIST 1.1) or at least one predominantly lytic bone lesion 9. Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer 10. Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane) Further inclusion criteria and details are described in the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 246 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 574
Exclusion criteria
Exclusion criteria: 1. Patient with symptomatic visceral disease or any prohibitive disease burden 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 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 except alopecia Further exclusion criteria and details are described in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether treatment with alpelisib in combination with fulvestrant prolongs PFS compared to treatment with placebo in combination with fulvestrant for patients with PIK3CA mutant status;Secondary Objective: To determine whether treatment with alpelisib in combination with fulvestrant prolongs overall survival (OS) compared to treatment with placebo in combination with fulvestrant for patients with PIK3CA mutant status To establish proof of concept of treatment benefit with alpelisib in combination with fulvestrant with respect to PFS for patients with PIK3CA non-mutant status To evaluate the two treatment arms with respect to OS for patients with PIK3CA non-mutant status To evaluate the two treatment arms and cohorts of interest with respect to overall response rate (ORR) and clinical benefit rate Further secondary objectives and details are described in the protocol ;Primary end point(s): PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA mutant cohort;Timepoint(s) of evaluation of this end point: At screening/baseline, every 8 weeks after randomization during the first 18 months and every 12 weeks until 36 months, then change to as clinically indicated | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort OS in each of the PIK3CA mutant and non-mutant cohorts ORR and CBR in each of the PIK3CA mutant and non-mutant cohorts Further secondary endpoints are described in the protocol;Timepoint(s) of evaluation of this end point: At screening/baseline, every 8 weeks after randomization during the first 18 months and every 12 weeks until 36 months, then change to as clinically indicated | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Norway, Peru, Portugal, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed