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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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

Conditions

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Breast Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle

Biopsy

Cyclophosphamide

Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle

Intervention Type DRUG

Capecitabine

Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle

Intervention Type DRUG

Vinorelbine

Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle

Intervention Type DRUG

Gemcitabine

Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Kathy Miller, MD

Professor, IU School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathy Miller, M.D.

Role: STUDY_CHAIR

Hoosier Oncology Group, LLC

George Sledge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hoosier Oncology Group, LLC

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United States Peru

Other Identifiers

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Department of Defense BC030400

Identifier Type: REGISTRY

Identifier Source: secondary_id

HOG COE-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

A

Biopsy

Serum Collection

Urine Collection

Doxorubicin

Cyclophosphamide

B

Biopsy

Serum Collection

Urine Collection

Capecitabine

C

Biopsy

Serum Collection

Urine Collection

Vinorelbine

D

Biopsy

Serum Collection

Urine Collection

Gemcitabine

Interventions

Biopsy

Serum Collection

Urine Collection

Doxorubicin

Cyclophosphamide

Capecitabine

Vinorelbine

Gemcitabine

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

United States Department of Defense

Indiana University School of Medicine

Walther Cancer Institute

Hoosier Cancer Research Network

Responsible Party

Kathy Miller, MD

Principal Investigators

Kathy Miller, M.D.

George Sledge, M.D.

Locations

Cancer Care Center of Southern Indiana

Fort Wayne Oncology & Hematology, Inc

Center for Cancer Care at Goshen Health System

Indiana University Cancer Center

Mary Lou Mayer, M.D.

Community Regional Cancer Center

Arnett Cancer Care

Horizon Oncology Center

Northern Indiana Cancer Research Consortium

Baylor College of Medicine - Methodist Breast Center

Instituto de Enfermedades Neoplasticas (INEN)

Countries

Related Links

Other Identifiers

Department of Defense BC030400

HOG COE-01