Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

NCT07164976 | Recruiting Phase 1 DMC

• 1 other identifier: NCU-002-Ribo(M)
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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-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

Breast Cancer

Keywords

breast cancer; ribociclib

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Phase 1b part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From enrollment to the end of treatment at 4 weeks

• Phase 1b part: Peak Plasma Concentration (Cmax)

  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

• Phase 2 part: PFS

  Time Frame: From enrollment to the end of treatment at 24 weeks

• Phase 2 part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From enrollment to the end of treatment at 24 weeks

Study Arms (3)

phase 1b cohort 1

EXPERIMENTAL

phase 1b cohort 1

Drug: Ribociclib 400mg

phase 1b cohort 2

EXPERIMENTAL

phase 1b cohort 2

Drug: Ribociclib 600mg

phase 2 part

EXPERIMENTAL

Drug: Ribociclib 600mg

Interventions

Ribociclib 400mg DRUG

phase 1b cohort 1

phase 1b cohort 1

Ribociclib 600mg DRUG

Phase 1b cohort 2

phase 1b cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nagoya City University: lead
• Novartis: collaborator

Study Sites (1)

Nagoya City University

Nagoya, Japan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hiroji Iwata, MD. PhD.

  Nagoya City University

  STUDY CHAIR

Central Study Contacts

Kazuki Nozawa

CONTACT

+81-52-853-8020; ribociclib_IIS_CMIC@cmic.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

JP (1)