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
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Biopsy
Procedure: Serum Collection
Procedure: Urine Collection
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Vinorelbine
Drug: Gemcitabine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

core biopsy, serum, urine


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study limited to patients with breast cancer.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235235

Locations
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
Mary Lou Mayer, M.D.
Indianapolis, Indiana, United States, 46227
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Texas
Baylor College of Medicine - Methodist Breast Center
Houston, Texas, United States, 77030
Peru
Instituto de Enfermedades Neoplasticas (INEN)
Lima, Peru
Sponsors and Collaborators
Hoosier Cancer Research Network
Indiana University School of Medicine
Walther Cancer Institute
Investigators
Study Chair: Kathy Miller, M.D. Hoosier Oncology Group, LLC
Principal Investigator: George Sledge, M.D. Hoosier Oncology Group, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Kathy Miller, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00235235     History of Changes
Other Study ID Numbers: HOG COE-01, Department of Defense BC030400
Study First Received: October 6, 2005
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Doxorubicin
Cyclophosphamide
Liposomal doxorubicin
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014