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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00088829
Recruitment Status : Terminated (Investigator left institution)
First Posted : August 5, 2004
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: paclitaxel Genetic: microarray analysis Procedure: biopsy Procedure: neoadjuvant therapy Drug: Paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : April 2001
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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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

Drug: Paclitaxel
All patients will receive paclitaxel neoadjuvantly
Other Name: Taxol


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response [ Time Frame: 3 months ]
    Due to the early termination of the study, this data for this outcome was not collected.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088829


Locations
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United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Minetta C. Liu, MD Lombardi Comprehensive Cancer Center
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00088829    
Other Study ID Numbers: CDR0000368453
P50CA058185 ( U.S. NIH Grant/Contract )
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-00310
First Posted: August 5, 2004    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018
Last Verified: May 2018
Keywords provided by Georgetown University:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
 stage IA breast cancer
stage IB breast cancer
HER2-negative breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action