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Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

NCT06635447 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy.

The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.

Conditions

Interventions

DRUG

Capivasertib

400 mg, oral, twice daily; 4 days on and 3 days off

DRUG

Fulvestrant

Fulvestrant IV

Sponsors & Collaborators

Principal Investigators

  • Zefei Jiang, PhD · Clinical Trial Ethics Committee of The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-10-31
Completion
2027-01-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635447 on ClinicalTrials.gov