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

Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00235235

Enrollment

Registered

2005-10-10

Start date

2005-09-30

Completion date

2010-12-31

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

PROCEDUREBiopsy

core biopsy

PROCEDURESerum Collection

serum collection

PROCEDUREUrine Collection

urine collection

DRUGDoxorubicin

Doxorubicin 60 mg/m2 day 1 of every 21-day cycle

DRUGCyclophosphamide

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

DRUGCapecitabine

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

DRUGVinorelbine

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

DRUGGemcitabine

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer	36 months

Secondary

Measure	Time frame
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.	36 months
To compare serum and tissue proteomic analyses.	36 months
To compare genomic and proteomic profiles.	36 months
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.	36 months

Countries

Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026