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
Drug
Genetic
Procedure
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, 2001Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin 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

subjects will receive paclitaxel neoadjuvantly

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

All subjects will have a biopsy to collect tissue

paclitaxel is given neoadjuvantly

All patients will receive paclitaxel neoadjuvantly
Study Objectives
Primary Objectives

Due to the early termination of the study, this data for this outcome was not collected.

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 CenterWashington, United StatesSee the location

SuspendedOne Study Center
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