Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Paclitaxel; Genetic: microarray analysis; Procedure: biopsy; Procedure: neoadjuvant therapy

• Registration Number: NCT00088829
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2018-05
• Results First Submitted: 2018-05-02
• Results First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Results First Posted: 2018-07-11
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	microarray analysis	Paclitaxel given before surgery
Paclitaxel	biopsy	Paclitaxel given before surgery
Paclitaxel	neoadjuvant therapy	Paclitaxel given before surgery
Paclitaxel	Paclitaxel	Paclitaxel given before surgery

Primary Outcome Measures

Name	Time	Method
Overall Response	3 months	Due to the early termination of the study, this data for this outcome was not collected.

Trial Locations

Locations (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States