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

This study has been terminated.
(Funding terminated)
Sponsor:
Collaborators:
Indiana University School of Medicine
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00235235
First received: October 6, 2005
Last updated: April 28, 2011
Last verified: April 2011

October 6, 2005
April 28, 2011
September 2005
December 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
- To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
Complete list of historical versions of study NCT00235235 on ClinicalTrials.gov Archive Site
  • To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To compare serum and tissue proteomic analyses. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To compare genomic and proteomic profiles. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To correlate toxicity and/or response with drug-specific pharmacogenomic parameters. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • - To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
  • - To compare serum and tissue proteomic analyses.
  • - To compare genomic and proteomic profiles.
  • - To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
Not Provided
Not Provided
 
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

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.

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 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
  • Arm B: Capecitabine 1000 mg/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 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Performance status & Organ Function:

Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).

Life Expectancy: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Cardiovascular: Not specified

Pulmonary: Not specified

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

core biopsy, serum, urine

Probability Sample

Study limited to patients with breast cancer.

Breast Cancer
  • Procedure: Biopsy
    core biopsy
  • Procedure: Serum Collection
    serum collection
  • Procedure: Urine Collection
    urine collection
  • Drug: Doxorubicin
    Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
  • Drug: Cyclophosphamide
    Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
  • Drug: Capecitabine
    Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
  • Drug: Vinorelbine
    Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
  • Drug: Gemcitabine
    Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
  • A
    Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
    Interventions:
    • Procedure: Biopsy
    • Procedure: Serum Collection
    • Procedure: Urine Collection
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
  • B
    Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
    Interventions:
    • Procedure: Biopsy
    • Procedure: Serum Collection
    • Procedure: Urine Collection
    • Drug: Capecitabine
  • C
    Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
    Interventions:
    • Procedure: Biopsy
    • Procedure: Serum Collection
    • Procedure: Urine Collection
    • Drug: Vinorelbine
  • D
    Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
    Interventions:
    • Procedure: Biopsy
    • Procedure: Serum Collection
    • Procedure: Urine Collection
    • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
    2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
    3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
    4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Exclusion Criteria:

  • 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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Peru
 
NCT00235235
HOG COE-01, Department of Defense BC030400
Yes
Kathy Miller, M.D., Hoosier Oncology Group
Hoosier Cancer Research Network
  • Department of Defense
  • Indiana University School of Medicine
  • Walther Cancer Institute
Study Chair: Kathy Miller, M.D. Hoosier Oncology Group, LLC
Principal Investigator: George Sledge, M.D. Hoosier Oncology Group, LLC
Hoosier Cancer Research Network
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP