Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

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-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K.. Study Design and Endpoints: The trial is structured into two parts: * Phase Ib: The prima

Trial Details

NCT ID
NCT07164976
Phase
PHASE1 / PHASE2
Sponsor
Nagoya City University
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Ribociclib 400mg
  • Ribociclib 600mg
Locations (sample)
  • Nagoya, Japan|35.18147,136.90641

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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