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

December 8, 2015 updated by: Kathy Miller, MD, Hoosier Cancer Research Network

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 + 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

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Instituto de Enfermedades Neoplasticas (INEN)
  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center of Southern Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Goshen, Indiana, United States, 46527
        • Center for Cancer Care at Goshen Health System
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46256
        • Community Regional Cancer Center
      • Indianapolis, Indiana, United States, 46227
        • Mary Lou Mayer, M.D.
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Care
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Methodist Breast Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Study limited to patients with breast cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
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
B
Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
Procedure: Biopsy
core biopsy
Procedure: Serum Collection
serum collection
Procedure: Urine Collection
urine collection
Drug: Capecitabine
Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
C
Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
Procedure: Biopsy
core biopsy
Procedure: Serum Collection
serum collection
Procedure: Urine Collection
urine collection
Drug: Vinorelbine
Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
D
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
Procedure: Biopsy
core biopsy
Procedure: Serum Collection
serum collection
Procedure: Urine Collection
urine collection
Drug: Gemcitabine
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
Time Frame: 36 months
36 months
To compare serum and tissue proteomic analyses.
Time Frame: 36 months
36 months
To compare genomic and proteomic profiles.
Time Frame: 36 months
36 months
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoosier Cancer Research Network

Collaborators

United States Department of Defense
Indiana University School of Medicine
Walther Cancer Institute

Investigators

  • Principal Investigator: George Sledge, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOG COE-01
  • Department of Defense BC030400 (Registry Identifier: ClinicalTrials.Gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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