A PHASE II, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 400 MG OF RIBOCICLIB IN COMBINATION WITH NON-STEROIDAL AROMATASE INHIBITORS FOR THE TREATMENT OF PRE- AND POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHO RECEIVED NO PRIOR THERAPY FOR ADVANCED DISEASE
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-021-19
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 1
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Assessed by local investigators according to RECIST 1.1<br>Measure:Overall response rate (ORR)<br><br>Timepoints:Tumor assessment after all patients have been treated for at least 6 months or have discontinued study treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:QTc: analysis of ECG performed at baseline and Cycle 1 Day 15<br>The following will be assessed according to RECIST 1.1<br>PFS: time from randomization to the first documented disease progression or death due to any cause.<br>CBR: proportion of patients with a best overall response of complete response (CR), or partial (PR), or stable disease SD.<br>TTR: time from the randomization to the first<br>documented response of complete response (CR) or partial (PR).<br>DOR: patients whose best overall response is complete response (CR) or partial response (PR)<br><br>Measure:QTc (with Fridericia,s correction) profile<br>- Progression free survival (PFS)<br>- Clinical benefit rate (CBR)<br>- Time to response (TTR)<br>- Duration of response (DOR)<br><br>Timepoints:Analyses of secondary endpoints will be performed after all patients have been treated for at least 6 months or have discontinued study treatment.<br>