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Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

NCT07164976 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-13

No results posted yet for this 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

Conditions

Interventions

DRUG

Ribociclib 400mg

phase 1b cohort 1

DRUG

Ribociclib 600mg

Phase 1b cohort 2

DRUG

Ribociclib 600mg

phase 2

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Nagoya City University

    lead OTHER

Principal Investigators

  • Hiroji Iwata, MD. PhD. · Nagoya City University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2029-09-01
Completion
2030-04-01

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164976 on ClinicalTrials.gov