RecruitingPhase 3NCT06635447

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

A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients

Sponsor

AstraZeneca

Enrollment

300 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — capivasertib and fulvestrant — for Chinese patients with advanced HR-positive, HER2-negative breast cancer (a common type that is driven by hormones but not by the HER2 protein). Capivasertib blocks a cell growth pathway that is often overactive in this cancer type. The study is specifically for patients whose cancer has certain genetic mutations (PIK3CA, AKT1, or PTEN). **You may be eligible if...** - You are 18 or older with HR-positive, HER2-negative breast cancer (locally advanced or metastatic) - Your tumor has been confirmed to have a PIK3CA, AKT1, or PTEN mutation - Your cancer has progressed after previous hormone (endocrine) therapy - Your overall health status is good (ECOG 0–1) and you have adequate organ function - You are eligible for fulvestrant treatment as assessed by your doctor - Premenopausal women can enroll if willing to take an LHRH agonist alongside **You may NOT be eligible if...** - Your cancer is rapidly progressing and requires urgent chemotherapy - You have had more than 2 prior lines of endocrine therapy for advanced disease (Cohort 1) or more than 1 (Cohort 2) - You previously received fulvestrant or other SERDs (Cohort 1), or AKT/PI3K/mTOR inhibitors - You have brain metastases requiring steroids, or leptomeningeal spread - You have significant heart disease, dangerous heart rhythm abnormalities, or uncontrolled high blood sugar - You are pregnant or breastfeeding - You have active hepatitis B or C, active tuberculosis, or HIV not well controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCapivasertib

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

DRUGFulvestrant

Fulvestrant IV

Locations(82)

Research Site

Hangzhou, China

Research Site

Harbin, China

Research Site

Hefei, China

Research Site

Hangzhou, China

Research Site

Dalian, China

Research Site

Dalian, China

Research Site

Hangzhou, China

Research Site

Hangzhou, China

Research Site

Hangzhou, China

Research Site

Guangzhou, China

Research Site

Baoding, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Chengdu, China

Research Site

Bengbu, China

Research Site

Deyang, China

Research Site

Guiyang, China

Research Site

Fuzhou, China

Research Site

Fuzhou, China

Research Site

Foshan, China

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Changchun, China

Research Site

Hohhot, China

Research Site

Huizhou, China

Research Site

Jinhua, China

Research Site

Jining, China

Research Site

Kashgar, China

Research Site

Linhai, China

Research Site

Meizhou, China

Research Site

Suzhou, China

Research Site

Nanning, China

Research Site

Nanchong, China

Research Site

Tianjin, China

Research Site

Shantou, China

Research Site

Sichuan, China

Research Site

Suining Shi, China

Research Site

Tangshan, China

Research Site

Ürümqi, China

Research Site

Ürümqi, China

Research Site

Wanzhou, China

Research Site

Weifang, China

Research Site

Xuzhou, China

Research Site

Yinchuan, China

Research Site

Zhanjiang, China

Research Site

Shenzhen, China

Research Site

Wuhan, China

Research Site

Shanghai, China

Research Site

Shanghai, China

Research Site

Nanjing, China

Research Site

Qingdao, China

Research Site

Ningbo, China

Research Site

Ningbo, China

Research Site

Lanzhou, China

Research Site

Zhengzhou, China

Research Site

Zhengzhou, China

Research Site

Kunming, China

Research Site

Jinan, China

Research Site

Nanchang, China

Research Site

Nanchang, China

Research Site

Xi'an, China

Research Site

Xi'an, China

Research Site

Shenyang, China

Research Site

Shenyang, China

Research Site

Xiamen, China

Research Site

Wenzhou, China

Research Site

Hefei, China

Research Site

Dongguan, China

Research Site

Taiyuan, China

Research Site

Changsha, China

Research Site

Changsha, China

Research Site

Changsha, China

Research Site

Shijiazhuang, China

Research Site

Shenzhen, China

Research Site

Wuhan, China

Research Site

Shanghai, China

Research Site

Shanghai, China

Research Site

Beijing, China

Research Site

Zhengzhou, China

Research Site

Xi'an, China

Research Site

Xi'an, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06635447

Related Trials

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

NCT034128771 location

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

NCT0560144010 locations

Genomic Services Research Program

NCT025959571 location

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

NCT045238571 location

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521158 locations