Actively Recruiting
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Led by Nagoya City University · Updated on 2026-04-13
86
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
N
Nagoya City University
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Hormone receptor-positive (ER positive and/or PgR positive) and HER2-negative disease
- ER positive defined as �3e�3d1% positive cells or Allred score �3e�3d3
- PgR positive defined as �3e�3d1% positive cells or Allred score �3e�3d3
- HER2 negative defined as IHC 0, 1+, or 2+ with no ISH amplification
- Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV)
- Age 18 years or older at registration
- ECOG Performance Status of 0-1
You will not qualify if you...
- Symptomatic visceral metastases or unsuitable for endocrine therapy
- Prior endocrine therapy or chemotherapy for metastatic or recurrent disease
- Prior exposure to CDK4/6 inhibitors in any setting
- Adjuvant endocrine therapy within 35 days before study start
- Active malignancy other than allowed exceptions (e.g., resected skin cancers, cancers disease-free for 5 years or more)
- Hypersensitivity to ribociclib, anastrozole, or their components including soy or peanut allergy and sugar intolerances
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Trial Site Locations
Total: 1 location
1
Nagoya City University
Nagoya, Japan
Actively Recruiting
Research Team
K
Kazuki Nozawa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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