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

June 15, 2018 updated by: Georgetown University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel
Paclitaxel given before surgery
Drug: paclitaxel
subjects will receive paclitaxel neoadjuvantly
Genetic: microarray analysis
subjects will have a biopsy to collect tissue for gene microarray analysis
Procedure: biopsy
All subjects will have a biopsy to collect tissue
Procedure: neoadjuvant therapy
paclitaxel is given neoadjuvantly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response
Time Frame: 3 months
Due to the early termination of the study, this data for this outcome was not collected.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Minetta C. Liu, MD, Lombardi Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 4, 2004

First Submitted That Met QC Criteria

August 4, 2004

First Posted (Estimate)

August 5, 2004

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000368453
  • P30CA051008 (U.S. NIH Grant/Contract)
  • P50CA058185 (U.S. NIH Grant/Contract)
  • GUMC-00310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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