RecruitingPhase 3NCT04263298

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

A Randomized, Multi-center, Open-label, Phase III Trial of Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer (FAMILY)


Sponsor

Herui Yao

Enrollment

210 participants

Start Date

May 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two maintenance (ongoing) treatments for women with hormone receptor-positive, HER2-negative metastatic breast cancer after completing initial chemotherapy: fulvestrant (a hormone-blocking injection) versus capecitabine (an oral chemotherapy pill), to find out which keeps the cancer at bay longer. **You may be eligible if:** - You are a woman aged 18–75 with advanced hormone receptor-positive, HER2-negative breast cancer - Your cancer did not progress (was stable, improved, or completely responded) after 4–8 cycles of first-line chemotherapy - You have not had more than one prior chemotherapy line for advanced disease **You may NOT be eligible if:** - Your cancer progressed during your initial chemotherapy - You have already received fulvestrant or other hormonal treatments for metastatic disease - You are pregnant or breastfeeding - You have significant organ dysfunction 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.

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Interventions

DRUGFulvestrant

Fulvestrant 500mg Days 0, 14, 28, then every 28 days

DRUGCapecitabine Oral Product

Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off


Locations(13)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Public Health Institute of Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Shantou Central Hospital

Shantou, Guangdong, China

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhangjiang, Guangdong, China

Fifth Subsidiary Sun Yat-sen University Hospital

Zhuhai, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT04263298


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