Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00235235
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:
NCT00235235
Study Brief:
Protocol Section:
NCT00235235