Clinical trial NCT00235235: A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Indiana University School of Medicine
name: Walther Cancer Institute
First posted: 2005-10-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study limited to patients with breast cancer.

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

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.

Primary outcomes:
measure: To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
timeFrame: 36 months
Secondary outcomes:
measure: To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
timeFrame: 36 months
measure: To compare serum and tissue proteomic analyses.
timeFrame: 36 months
measure: To compare genomic and proteomic profiles.
timeFrame: 36 months
measure: To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
timeFrame: 36 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Cancer Care Center of Southern Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Mary Lou Mayer, M.D.
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Houston
country: United States
facility: Baylor College of Medicine - Methodist Breast Center
state: Texas
city: Lima
country: Peru
facility: Instituto de Enfermedades Neoplasticas (INEN)
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Kathy Miller, M.D.
role: STUDY_CHAIR
affiliation: Hoosier Oncology Group, LLC
name: George Sledge, M.D.
role: PRINCIPAL_INVESTIGATOR
References: