NCT07164976 Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
| NCT ID | NCT07164976 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Nagoya City University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 86 participants in total. It began in 2025-10-01 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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).
Contact & Investigator
Hiroji Iwata, MD. PhD.
STUDY CHAIR
Nagoya City University
Frequently Asked Questions
Who can join the NCT07164976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07164976 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07164976 currently recruiting?
Yes, NCT07164976 is actively recruiting participants. Contact the research team at ribociclib_IIS_CMIC@cmic.co.jp for enrollment information.
Where is the NCT07164976 trial being conducted?
This trial is being conducted at Nagoya, Japan.
Who is sponsoring the NCT07164976 clinical trial?
NCT07164976 is sponsored by Nagoya City University. The principal investigator is Hiroji Iwata, MD. PhD. at Nagoya City University. The trial plans to enroll 86 participants.
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