Suspended

A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel

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What is being tested

paclitaxel

+ microarray analysis

+ biopsy

DrugGeneticProcedure
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: April 2001
See protocol details

Summary

Principal SponsorGeorgetown University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitleA Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer: Identifying Factors Predictive of a Response to Paclitaxel 
NCT00088829
Principal SponsorGeorgetown University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

Criteria

Inclusion: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Paclitaxel given before surgery

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington, United StatesSee the location
SuspendedOne Study Center