CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 210 target
Drug / intervention
Fulvestrant +1 moredrug
Likely dose
Fulvestrant 500mgfrom record
Key inclusion· 6
  • ✓Adult female patients aged 18-75 with advanced breast cancer not suitable for surgical resection or radiation therapy for cure
  • ✓ER and/or PR positive (>1% staining), HER-2 negative
  • ✓No disease progression after 4-8 courses of first-line chemotherapy (CR/PR/SD); capecitabine monotherapy allowed up to 6 courses
  • ✓Imaging within 3 weeks before enrollment to assess tumor lesions
Key exclusion· 7
  • ✕Newly developed CNS metastasis or symptom control <4 weeks; asymptomatic stable CNS metastases >4 weeks allowed
  • ✕Other malignant tumor diagnosed within 3 years (except basal/squamous cell skin cancer or cervical cancer in situ)
  • ✕Endocrine therapy for advanced disease
  • ✕Pregnant or breast-feeding patients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04263298
NCT04263298Phase 3RecruitingUpdate OverdueUpdated 45mo ago · Completion was 14mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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)

Herui Yao·interventional·Posted Feb 10, 2020·Updated Sep 30, 2022

In Brief

A Phase 3 clinical trial evaluating Fulvestrant and Capecitabine Oral Product for Metastatic Breast Cancer. Currently recruiting, targeting 210 participants across 13 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
2018201920202021202220232024202520262027202820292030
First PostedFeb 10, 2020
Enrollment StartMay 1, 2018
Primary CompletionMay 1, 2025
Study CompletionMay 1, 2030
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 6.4 years ago

Interventions

Fulvestrantdrug

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

Capecitabine Oral Productdrug

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