CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
capecitabine +1 moredrug
Likely dose
capecitabine 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00534417
NCT00534417Phase 2Completed
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Phase II Trial of Capecitabine in Combination With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

Accelerated Community Oncology Research Network·interventional·Posted Sep 24, 2007·Updated Feb 1, 2013

In Brief

A Phase 2 clinical trial evaluating capecitabine and fulvestrant for Metastatic Breast Cancer. Completed, enrolled 41 participants across 10 sites.

Detailed Summary

The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsHoffmann-La Roche, AstraZeneca

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartOct 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.8 years ago

Interventions

capecitabinedrug

Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight \< 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg.

fulvestrantdrug

Fulvestrant will be given at 500mg on Day 1 followed by 250 mg on Days 15 and 29, then 250mg every 28 days(Q28d).