NCT00570258View on ClinicalTrials.gov

Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy

PHASE2TerminatedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2017

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Fulvestrant

Fulvestrant: 250 mg IM Q 4 weeks

DRUG

erlotinib

150 mg PO QD

DRUG

Fulvestrant

250 mg IM Q 4 weeks

DRUG

Placebo

Placebo 150 mg PO QD

Trial Locations (6)

30322

Emory University, Atlanta

64111

St. Luke's Cancer Institute, Kansas City

72205

University of Arkansas for Medical Sciences, Little Rock

72401

NEA Clinic, Jonesboro

72764

Highlands oncology Group, Springdale

07601

Hackensack University, Hackensack

Sponsors

Collaborators (1)

OSI Pharmaceuticals
All Listed Sponsors
collaborator

OSI Pharmaceuticals

INDUSTRY

lead

University of Arkansas

OTHER

NCT00570258 - Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy | Biotech Hunter | Biotech Hunter