Status:
NOT_YET_RECRUITING
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Lead Sponsor:
Nagoya City University
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer.
- Hormone receptor-positive (ER positive and/or PgR positive) and HER2-negative disease:
- ER positive: ≥1% positive cells or Allred score ≥3.
- PgR positive: ≥1% positive cells or Allred score ≥3.
- HER2 negative: IHC 0, 1+, or 2+ with no ISH amplification.
- Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV).
- Age ≥18 years at registration.
- ECOG Performance Status of 0-1.
Exclusion
- Symptomatic visceral metastases or deemed unsuitable for endocrine therapy.
- Prior endocrine therapy or chemotherapy for metastatic/recurrent disease.
- Prior CDK4/6 inhibitor exposure (perioperative or metastatic setting).
- Adjuvant endocrine therapy within 35 days before study start.
- Active malignancy other than allowed exceptions (e.g., resected skin cancers, ≥5-year disease-free cancers).
- Hypersensitivity to ribociclib, anastrozole, or their components (including soy/peanut allergy, sugar intolerances).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT07164976
Start Date
October 1 2025
End Date
April 1 2030
Last Update
September 10 2025
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