Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Metastatic Breast Cancer
Interventions
DRUG

capecitabine

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.

DRUG

fulvestrant

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

Trial Locations (10)

17605

The Lancaster Cancer Center, Ltd, Lancaster

23320

Cancer Specialists of Tidewater, Chesapeake

30607

Northeast Georgia Cancer Care, Athens

30901

Augusta Oncology Associates, Augusta

33176

Advanced Medical Specialties, Miami

38120

The West Clinic, Memphis

59101

Hematology Oncology Centers of the Northern Rockies, Billings

60068

Oncology Specialists, Park Ridge

61401

Medical & Surgical Specialists, Galesburg

89052

Las Vegas Cancer Center, Henderson

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Accelerated Community Oncology Research Network

OTHER