None listed
Conditions
Interventions
Ribociclib 400 mg (2 x 200 mg tablets by mouth) QD on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28) + letrozole 2.5 mg by mouth QD continuously or anastrozole 1 mg by mouth QD continuously (+ goserelin 3.6 mg subcutaneously once every 4 weeks for premenopausal women)
Group name:Arm 2 Type of group
Ribociclib 600 mg (3 x 200 mg tablets by mouth) QD on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28) + letrozole 2.5 mg by mouth QD continuously or anastrozole 1 mg by mouth QD continuously (+ goserelin 3.6 mg subcutaneously once every 4 weeks for premenopausal women)  
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria: • Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy. • Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample. • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH). • Patient must have measurable disease. • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. • Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory: • QTc interval at screening < 450 ms (using Fridericia’s correction) • Mean resting heart rate 50 to 90 bpm (determined from the ECG) • Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization. • Women of CBP must be willing to use highly effective methods of contraception.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: • Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s judgment. • Received any prior systemic anti-cancer therapy (including endocrine therapy, chemotherapy, prior CDK4/6 inhibitors) for aBC. Patients who received neo-/adjuvant therapy for breast cancer are eligible. • Concurrently using other anti-cancer therapy. • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities. • Patient has received extended-field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy . • Concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ. • Patients with central nervous system (CNS) involvement unless they meet specific stability criteria. • Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. • Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, and has not fully recovered from side effects of such treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Assessed by local investigators according to RECIST 1.1 Measure:Overall response rate (ORR) Timepoints:Tumor assessment after all patients have been treated for at least 6 months or have discontinued study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:QTc: analysis of ECG performed at baseline and Cycle 1 Day 15 The following will be assessed according to RECIST 1.1 PFS: time from randomization to the first documented disease progression or death due to any cause. CBR: proportion of patients with a best overall response of complete response (CR), or partial (PR), or stable disease SD. TTR: time from the randomization to the first documented response of complete response (CR) or partial (PR). DOR: patients whose best overall response is complete response (CR) or partial response (PR) Measure:QTc (with Fridericia,s correction) profile - Progression free survival (PFS) - Clinical benefit rate (CBR) - Time to response (TTR) - Duration of response (DOR) Timepoints:Analyses of secondary endpoints will be performed after all patients have been treated for at least 6 months or have discontinued study treatment. | — |
Countries
Arabia Saudi, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hungary, India, Jordan, Lithuania, Portugal, Russian Federation, South Africa, Sweden, Thailand, United States
Contacts
Public ContactFiorella Ramirez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed