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Clinical Trials in Japan / NCT07164976
Recruiting Phase 1/2

Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

NCT07164976 · tracked via the Priya Life Science Japan tracker
Sponsor
Nagoya City University
Phase
Phase 1/2
Started
2025-10-01
Last updated
2026-04-13

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Ribociclib 400mg →Ribociclib 600mg →Ribociclib 600mg →

Ribociclib 400mg: phase 1b cohort 1

Ribociclib 600mg: Phase 1b cohort 2

Ribociclib 600mg: phase 2

Study 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-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 primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
* Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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. 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 Criteria: * 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).

Primary outcome measure(s)

  • Phase 1b part: Dose Limiting Toxicity — From enrollment to the end of treatment at 4 weeks
  • Phase 2 part: Overall response rate — From enrollment to the end of treatment at 24 weeks

Trial sites (1)

FacilityCityRegionStatus
Nagoya City University Nagoya Japan Recruiting

More Nagoya City University trials in Japan

Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment Active, not recruiting
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer Starting soon
The Real-world Treatment Satisfaction by Gefapixiant in RCC Recruiting
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer Recruiting

Other trials for the same condition

PALbociclib CoLlaborative Adjuvant Study Active, not recruiting
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH) Recruiting
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 Recruiting
Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE) Recruiting
A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164976 on ClinicalTrials.gov ↗ ← All trials in Japan