Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer (NCT07164976) | Clinical Trial Compass
RecruitingPhase 1/2
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Japan86 participantsStarted 2025-10-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1b part: Dose Limiting Toxicity
Timeframe: From enrollment to the end of treatment at 4 weeks
2
Phase 2 part: Overall response rate
Timeframe: From enrollment to the end of treatment at 24 weeks