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

NCT ID: NCT00088829

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Paclitaxel

Paclitaxel given before surgery

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

subjects will receive paclitaxel neoadjuvantly

microarray analysis

Intervention Type: GENETIC

subjects will have a biopsy to collect tissue for gene microarray analysis

biopsy

Intervention Type: PROCEDURE

All subjects will have a biopsy to collect tissue

neoadjuvant therapy

Intervention Type: PROCEDURE

paclitaxel is given neoadjuvantly

Paclitaxel

Intervention Type: DRUG

All patients will receive paclitaxel neoadjuvantly

Interventions

paclitaxel

subjects will receive paclitaxel neoadjuvantly

Intervention Type: DRUG

microarray analysis

subjects will have a biopsy to collect tissue for gene microarray analysis

Intervention Type: GENETIC

biopsy

All subjects will have a biopsy to collect tissue

Intervention Type: PROCEDURE

neoadjuvant therapy

paclitaxel is given neoadjuvantly

Intervention Type: PROCEDURE

Paclitaxel

All patients will receive paclitaxel neoadjuvantly

Intervention Type: DRUG

Other Intervention Names

Taxol

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed infiltrating carcinoma of the breast

• Unresected disease
• High-risk (> 50% risk of relapse) disease, including any of the following high-risk markers:

• Estrogen receptor- and progesterone receptor- negative
• Palpable axillary lymph nodes
• Grade 3 histology
• S phase fraction > 10%
• Ki67 > 30%
• Disease that warrants combination therapy with doxorubicin, cyclophosphamide, and paclitaxel
• HER2/neu negative or positive
• Hormone receptor status:

• Not specified

Menopausal status

• Known

Performance status

• ECOG 0-2
• Absolute neutrophil count > 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1. 5 times normal (except for patients with known Gilbert's disease)
• Creatinine ≤ 1.5 times normal

Exclusion:

• uncontrolled congestive heart failure
• myocardial infarction within the past 6 months
• unstable angina
• uncontrolled hypertension
• pregnant or nursing
• serious bacterial, viral, or fungal infection requiring ongoing treatment
• severe peripheral neuropathy
• poor psychiatric risk
• history of any other known serious co-morbid medical or psychiatric condition
• prior cytotoxic therapy for breast cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minetta C. Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

P50CA058185

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA051008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GUMC-00310

Identifier Type: -

Identifier Source: secondary_id

CDR0000368453

Identifier Type: -

Identifier Source: org_study_id