NCT07164976RecruitingPhase 1/2
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 23 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- Nagoya City University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07164976
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 86
- From 1 Oct 2025 to the primary completion date, 1 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nagoya City University Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.