OncRef

Clinical Trial: NCT04263298

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Herui Yao
Information Provided By:Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Update Posted:2022-09-30

Study Overview

Brief 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.

Official Title

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)

Conditions

Metastatic Breast Cancer

Intervention / Treatment

  • Drug: Fulvestrant
  • Drug: Capecitabine Oral Product

Other Study ID Numbers

  • SYS-C-201801-5010

Start Date (Actual)

2018-05-01

Primary Completion Date (Estimated)

2025-05-01

Study Completion Date (Estimated)

2030-05-01

Enrollment (Estimated)

210

Study Type

Interventional

Phase

Phase 3