Clinical trial NCT00088829
Conditions: Breast Cancer
Keywords: stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer stage IA breast cancer stage IB breast cancer HER2-negative breast cancer HER2-positive breast cancer
Sponsor: Georgetown University
Start date: 2001-04-01; Completion date: 2012-12-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.

PURPOSE: This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status.
* Determine a standard protocol template for gene microarray analysis, in terms of the timing and method of collecting tissue samples, before and after administration of neoadjuvant paclitaxel in these patients.
* Determine the safety and efficacy of tissue sampling in these patients.

Secondary

* Identify gene(s) or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients.
* Identify gene(s) or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients.
* Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug.
* Develop, preliminarily, a statistical model utilizing individual genes and/or gene clusters that can best predict response to paclitaxel in these patients.

OUTLINE: This is a pilot, multicenter study.

Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment. Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel, upon completion of course 1, and either upon completion of the last course (in patients with clinical or radiographic evidence of residual disease) or during definitive breast surgery. Biopsy samples are analyzed for gene expression by gene microarray analysis.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Arms: arm 1: Paclitaxel given before surgery
Interventions: intervention 1: paclitaxel intervention 2: microarray analysis intervention 3: biopsy intervention 4: neoadjuvant therapy intervention 5: Paclitaxel
Intervention descriptions: intervention 1: subjects will receive paclitaxel neoadjuvantly intervention 2: subjects will have a biopsy to collect tissue for gene microarray analysis intervention 3: All subjects will have a biopsy to collect tissue intervention 4: paclitaxel is given neoadjuvantly intervention 5: All patients will receive paclitaxel neoadjuvantly

Protocol documents: