A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT00235235
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    core biopsy
  • Serum Collection — PROCEDURE
    serum collection
  • Urine Collection — PROCEDURE
    urine collection
  • Doxorubicin — DRUG
    Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
  • Cyclophosphamide — DRUG
    Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
  • Vinorelbine — DRUG
    Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
  • Gemcitabine — DRUG
    Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Study Details

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 cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

Key Dates

Start date
Sep 30, 2005
Status verified
Dec 2015
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
80 participants (actual)

Arms

  • Arm: A
    Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
  • Arm: B
    Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
  • Arm: C
    Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
  • Arm: D
    Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Primary Outcome Measure

To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer [ Time Frame: 36 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Cancer Care Center of Southern IndianaBloomingtonIndiana47403-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Center for Cancer Care at Goshen Health SystemGoshenIndiana46527-
Community Regional Cancer CenterIndianapolisIndiana46256-
Indiana University Cancer CenterIndianapolisIndiana46202-
Mary Lou Mayer, M.D.IndianapolisIndiana46227-
Arnett Cancer CareLafayetteIndiana47904-
Horizon Oncology CenterLafayetteIndiana47905-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
Baylor College of Medicine - Methodist Breast CenterHoustonTexas77030-

Find similar trials in Bloomington, IN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cancer Care Center of Southern Indiana· Bloomington, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, INCenter for Cancer Care at Goshen Health System· Goshen, INCommunity Regional Cancer Center· Indianapolis, INIndiana University Cancer Center· Indianapolis, INMary Lou Mayer, M.D.· Indianapolis, IN

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