Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT00597597
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    During the treatment period, subjects will receive single agent erlotinib, 150mg/day.

Study Details

The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.

Key Dates

First listed
Jan 18, 2008
Start date
Apr 30, 2007
Status verified
May 2023
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open label Erlotinib
    Open label; In this open label study, all enrolled subjects receive active drug, Erlotinib

Primary Outcome Measure

The Primary Objective of the Study is Progression Free Survival. [ Time Frame: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical Center Division of Hematology/OncologyChicagoIllinois60612-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Rush University Medical Center Division of Hematology/Oncology· Chicago, IL

Related Studies