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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00235235
• Other study ID #: HOG COE-01
• Secondary ID: Department of De
• Status: Terminated
• Phase: N/A
• First received: October 6, 2005
• Last updated: December 8, 2015
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: December 2015
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Biopsy
core biopsy
• Serum Collection
serum collection
• Urine Collection
urine collection

Drug:
• Doxorubicin
Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
• Cyclophosphamide
Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
• Capecitabine
Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
• Vinorelbine
Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
• Gemcitabine
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Locations

Country	Name	City	State
Peru	Instituto de Enfermedades Neoplasticas (INEN)	Lima
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Baylor College of Medicine - Methodist Breast Center	Houston	Texas
United States	Community Regional Cancer Center	Indianapolis	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Mary Lou Mayer, M.D.	Indianapolis	Indiana
United States	Arnett Cancer Care	Lafayette	Indiana
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Indiana University School of Medicine, United States Department of Defense, Walther Cancer Institute

Countries where clinical trial is conducted

United States,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer		36 months	No
Secondary	To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.		36 months	No
Secondary	To compare serum and tissue proteomic analyses.		36 months	No
Secondary	To compare genomic and proteomic profiles.		36 months	No
Secondary	To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.		36 months	Yes

External Links

•   Hoosier Oncology Group Home Page