CDK4/6-inhibitor or Chemotherapy, in Combination With ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2
study, comparing two treatments for locally advanced or metastatic luminal breast cancer:
- Arm A: concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor (palbociclib,
ribociclib or abemaciclib) plus endocrine therapy (aromatase inhibitor [AI] or
fulvestrant)
- Arm B: chemotherapy plus endocrine therapy (AI or fulvestrant, administered either
concomitantly from the beginning of chemotherapy or sequentially after 4-6 months of
chemotherapy) Treatments will continue until disease progression or toxicity or patient
refusal.
Phase:
Phase 2
Details
Lead Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori