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Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01


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


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Kathy Miller, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

HOG COE-01

NCT ID:

NCT00235235

Start Date:

September 2005

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Horizon Oncology CenterLafayette, Indiana  47905
Community Regional Cancer CenterIndianapolis, Indiana  46256
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Mary Lou Mayer, M.D.Indianapolis, Indiana  46227
Baylor College of Medicine - Methodist Breast CenterHouston, Texas  77030