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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00088829
First received: August 4, 2004
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: paclitaxel
Genetic: microarray analysis
Procedure: biopsy
Procedure: neoadjuvant therapy
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Overall response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2001
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Paclitaxel
  • Taxol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088829

Locations
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
Investigators
Principal Investigator: Minetta C. Liu, MD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00088829     History of Changes
Other Study ID Numbers: CDR0000368453, P50CA058185, P30CA051008, GUMC-00310
Study First Received: August 4, 2004
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

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:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014