Status:
TERMINATED
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
United States Department of Defense
Indiana University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast...
Detailed Description
OUTLINE: This is a 4 arm, multi-center study. Sample Collection: * Core Biopsy * Serum * Urine Treatment Regimens (Investigator/Patient Discretion): * Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamid...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
- Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
- Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
- Planned chemotherapy with one of the following regimens:
- Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Exclusion
- No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
- Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
- Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
- No breast-feeding.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00235235
Start Date
September 1 2005
End Date
December 1 2010
Last Update
December 9 2015
Active Locations (11)
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1
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
2
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
3
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202