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NCT Number: NCT07164976

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 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ribociclib 400mg

Drug

phase 1b cohort 1

Ribociclib 600mg

Drug

Phase 1b cohort 2

Primary outcomes

  1. Phase 1b part: Dose Limiting Toxicity

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Phase 2 part: Overall response rate

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

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Phase 1b part: Peak Plasma Concentration (Cmax)

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. Phase 2 part: Overall Response Rate

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

  4. Phase 2 part: PFS

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kazuki Nozawa

CONTACT

[email protected]

+81-52-853-8020

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Collaborators

  • Novartis

Registry information

Official study title

Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 10, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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