Status:
COMPLETED
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
Brief Summary
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozol...
Detailed Description
Patients were assigned at visit Cycle 1 Day 1 to one of the following two treatment arms in a ratio of 1:1: * Experimental arm: Ribociclib 400 mg (2 × 200 mg tablets by mouth) QD on Days 1 to 21 of a...
Eligibility Criteria
Inclusion
- 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, and all tested by local laboratory.
- 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) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
- Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation).
- 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:
- QTcF interval at screening \< 450 ms (QT interval 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.
- Key Exclusion Criteria:
- Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's judgment.
- Patient who 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.
- Patient is 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 (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patients in whom ≥
- 25% of the bone marrow has been previously irradiated are also excluded.
- Patient has a 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.
- Other protocol-defined Inclusion/Exclusion may apply.
Exclusion
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT03822468
Start Date
June 11 2019
End Date
August 30 2024
Last Update
October 16 2025
Active Locations (89)
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1
Southern Cancer Center PC
Mobile, Alabama, United States, 36608
2
Marin Cancer Care
Greenbrae, California, United States, 94904
3
Rocky Mountain Cancer Centers
Longmont, Colorado, United States, 80501
4
Florida Retina Institute
Orlando, Florida, United States, 32804