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. |
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Condition | Breast Cancer |
Intervention | Procedure: Biopsy Procedure: Serum Collection Procedure: Urine Collection Drug: Doxorubicin Drug: Cyclophosphamide Drug: Capecitabine Drug: Vinorelbine Drug: Gemcitabine |
Phase | N/A |
Sponsor | Hoosier Oncology Group |
Responsible Party | Hoosier Oncology Group |
ClinicalTrials.gov Identifier | NCT00235235 |
First Received | October 6, 2005 |
Last Updated | April 28, 2011 |
Last verified | April 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | October 6, 2005 |
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Last Updated Date | April 28, 2011 |
Start Date | September 2005 |
Estimated Primary Completion Date | December 2010 |
Current 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] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer |
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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 |
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 Type | Observational |
Study Phase | N/A |
Study Design | Time Perspective: Prospective |
Condition | Breast Cancer |
Intervention | 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 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 80 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | December 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. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Peru |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00235235 |
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Other Study ID Numbers | HOG COE-01 |
Has Data Monitoring Committee | Yes |
Information Provided By | Hoosier Oncology Group |
Study Sponsor | Hoosier Oncology Group |
Collaborators | Department 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 Date | April 2011 |
Locations[ + expand ][ + ]
Cancer Care Center of Southern Indiana | Bloomington, Indiana, United States, 47403 |
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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 |