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

NCT04263298 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-09-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fulvestrant

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

DRUG

Capecitabine Oral Product

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

Sponsors & Collaborators

  • Herui Yao

    lead OTHER

Principal Investigators

  • Herui Yao, PhD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Shusen Wang, PhD · Sun Yat-sen University

  • Kun Wang, PhD · Guangdong Provincial People's Hospital

  • Peijian Peng, PhD · Fifth Subsidiary Sun Yat-sen University Hospital

  • Li Ling, PhD · Public Health Institute of Sun Yat-sen University

  • Yongkui Lu, MD · Affiliated Cancer Hospital of Guangxi Medical University

  • Quchang Ouyang, PhD · Hunan Cancer Hospital

  • Ying Lin, phD · First Affiliated Hospital, Sun Yat-Sen University

  • Ying Zhang, MD · Affiliated Hospital of Guangdong Medical University

  • Mei Huang, MD · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  • Zhiyong Wu, MD · Shantou Central Hospitalv

  • Cai'wen Du, PhD · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2025-05-01
Completion
2030-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04263298 on ClinicalTrials.gov