This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Male or female age ≥ 18 years at the time of consent.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor 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. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.
Patient with a known hypersensitivity to any of the excipients of ribociclib.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Single group
Ribociclib
Drug400 mg orally once daily Days 1-21 (28 day Cycle)
Fulvestrant
Drug500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+
Anastrozole
Drug1 mg orally once daily
Letrozole
Drug2.5 mg orally once daily
Exemestane
Drug25 mg orally once daily
Recurrence Free Survival (RFS)
Estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant). RFS is defined as interval from registration until invasive or DCIS recurrence in the ipsilateral breast or locoregionally, invasive recurrence at a distant site, or death from breast cancer or any other cause, whichever occurs first. The censoring time is the completion of study at 6 years (3 years of patient accrual and 3 years of follow up time). The RFS at 3 years will be also treated as the primary endpoint in the power and sample size calculation.
Distant Metastasis-Free Survival
Estimate the Distant metastasis-free survival. Distant metastasis-free survival is defined as interval from registration to any recurrence or death from any cause.
Overall Survival (OS)
Estimate the OS. OS is defined as interval from registration to death from any cause.
Assess adverse events
Evaluate safety and tolerability of the study regimen. Safety will be evaluated by recording frequency and severity of adverse events; grading of toxicities will be done using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5).
Click on the lead sponsor to view all of their trials.
Oana Danciu
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Novartis Pharmaceuticals
Collaborator
