Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ribociclib 400mg, Ribociclib 600mg, Ribociclib 600mg.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
Overview
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
Interventions
- Drug Ribociclib 400mg
phase 1b cohort 1 - Drug Ribociclib 600mg
Phase 1b cohort 2 - Drug Ribociclib 600mg
phase 2
Primary outcome measures
- Phase 1b part: Dose Limiting Toxicity [Time frame: From enrollment to the end of treatment at 4 weeks]
- Phase 2 part: Overall response rate [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (5)
- 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]
- Phase 1b part: Peak Plasma Concentration (Cmax) [Time frame: From enrollment to the end of treatment at 4 weeks]
- Phase 2 part: Overall Response Rate [Time frame: From enrollment to the end of treatment at 24 weeks]
- Phase 2 part: PFS [Time frame: 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 [Time frame: From enrollment to the end of treatment at 24 weeks]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Nagoya City University — Nagoya
Identifiers
NCT: NCT07164976 · NCU-002-Ribo(M)