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

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT00570258
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
    Fulvestrant: 250 mg IM Q 4 weeks
  • erlotinib — DRUG
    150 mg PO QD
  • Fulvestrant — DRUG
    250 mg IM Q 4 weeks
  • Placebo — DRUG
    Placebo 150 mg PO QD

Study Details

This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy. 1. To obtain preliminary estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib in this subject population, and 2. To obtain historically up-to-date estimates of the magnitude and variability of the efficacy of fulvestrant as the sole active agent in this subject population. The measure of efficacy for both primary objectives will be time to progression.

Key Dates

First listed
Dec 10, 2007
Start date
Sep 30, 2006
Status verified
Mar 2021
Primary completion
Dec 31, 2010
Completion
Dec 31, 2017

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 2
    Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD
  • Active Comparator: 1
    Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD

Primary Outcome Measure

Number of Participants With Progression-free Survival [ Time Frame: through study completion, an average of 3 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
NEA ClinicJonesboroArkansas72401-
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Highlands oncology GroupSpringdaleArkansas72764-
Emory UniversityAtlantaGeorgia30322-
St. Luke's Cancer InstituteKansas CityMissouri64111-
Hackensack UniversityHackensackNew Jersey07601-

Find similar trials in Jonesboro, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
NEA Clinic· Jonesboro, ARUniversity of Arkansas for Medical Sciences· Little Rock, ARHighlands oncology Group· Springdale, AREmory University· Atlanta, GASt. Luke's Cancer Institute· Kansas City, MOHackensack University· Hackensack, NJ

Related Studies