Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histopatologicznie rak piersi.
- •Rak piersi reagujący na hormony (ER+/PgR+) i nienależący do grupy HER2-.
- •Zaawansowany, nawrotowy lub rozprzestrzeniony rak piersi (IV stadium).
- •Pacjentki w wieku 18 lat i starsze.
- •Ogólny stan zdrowia pozwalający na normalną aktywność (status sprawności ECOG 0-1).
✗ Disqualifies
- •Objawowe przerzuty do narządów wewnętrznych.
- •Wcześniejsze leczenie hormonami lub chemioterapią z powodu zaawansowanego raka.
- •Wcześniejsze leczenie inhibitorami CDK4/6.
- •Uczulenie na którykolwiek ze składników leków (w tym na soję/orzeszki ziemne, nietolerancja cukrów).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Nagoya City University
Nagoya, Japan
Trial contact
Kazuki Nozawa
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.