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

Overview[ - collapse ][ - ]

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.
ConditionBreast Cancer
InterventionProcedure: Biopsy
Procedure: Serum Collection
Procedure: Urine Collection
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Vinorelbine
Drug: Gemcitabine
PhaseN/A
SponsorHoosier Oncology Group
Responsible PartyHoosier Oncology Group
ClinicalTrials.gov IdentifierNCT00235235
First ReceivedOctober 6, 2005
Last UpdatedApril 28, 2011
Last verifiedApril 2011

Tracking Information[ + expand ][ + ]

First Received DateOctober 6, 2005
Last Updated DateApril 28, 2011
Start DateSeptember 2005
Estimated Primary Completion DateDecember 2010
Current Primary Outcome MeasuresTo 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleA Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Official TitlePredicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
Brief Summary
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.
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 TypeObservational
Study PhaseN/A
Study DesignTime Perspective: Prospective
ConditionBreast Cancer
InterventionProcedure: 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
Study Arm (s)
  • A
    Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
  • B
    Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
  • C
    Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
  • D
    Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment80
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010
Eligibility 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.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Peru

Administrative Information[ + expand ][ + ]

NCT Number NCT00235235
Other Study ID NumbersHOG COE-01
Has Data Monitoring CommitteeYes
Information Provided ByHoosier Oncology Group
Study SponsorHoosier Oncology Group
CollaboratorsDepartment of Defense
Indiana University School of Medicine
Walther Cancer Institute
Investigators Study Chair: Kathy Miller, M.D. Hoosier Oncology Group, LLCPrincipal Investigator: George Sledge, M.D. Hoosier Oncology Group, LLC
Verification DateApril 2011

Locations[ + expand ][ + ]

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
Baylor College of Medicine - Methodist Breast Center
Houston, Texas, United States, 77030
Instituto de Enfermedades Neoplasticas (INEN)
Lima, Peru