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Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer

This study is currently recruiting participants.
Verified January 2012 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01514565
First received: January 17, 2012
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a prospective observational study aimed to validate biomarkers that predict response.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Histological status of retinoblastoma tumour suppressor (RB) [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
    The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.


Secondary Outcome Measures:
  • Correlation of RB and other biomarkers [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
    1. Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR
    2. Correlation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)

  • Determine the utility of an RB molecular test [ Time Frame: Assessed within 1 year ] [ Designated as safety issue: No ]
    Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.


Estimated Enrollment: 70
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A maximum of 70 eligible patients will be enrolled. Accrual is expected to be completed in 18-24 months. All patients must have histologically confirmed triple negative breast cancer and be eligible to receive neoadjuvant chemotherapy.

Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Histologically-confirmed triple negative invasive breast carcinoma
  • Any type of ductal or lobular invasive carcinoma
  • Patients with or without BRCA-1 and BRCA-2 mutations are eligible to participate
  • Life expectancy > 6 months
  • Pre-, Peri- or Postmenopausal
  • Clinical Stage T2-4, N0-3, M0 (Stage II-III)
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
  • Adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. However, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.

Exclusion Criteria:

  • Prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
  • Only ductal/lobular carcinoma in situ but not invasive component
  • Any sort of confirmed metastatic disease (AJCC Stage IV at diagnosis)
  • Any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
  • Pregnant or lactating, in case this precludes the subject to receive chemotherapy.
  • Impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. This will be exclusively decided by the treating oncologists.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514565

Contacts
Contact: Agnieszka Witkiewicz, MD 215-955-3778 Agnieszka.Witkiewicz@jefferson.edu
Contact: Gordon Schwartz, MD 215-955-6999 Gordon.Schwartz@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Agnieszka Witkiewicz, MD     215-955-3778     Agnieszka.Witkiewicz@jefferson.edu    
Contact: Gordon Schwartz, MD     215-955-6999     Gordon.Schwartz@jefferson.edu    
Sub-Investigator: Matias Valsecchi, MD            
Sub-Investigator: A. Kathleen McClendon, PhD            
Sub-Investigator: Adam Berger, MD            
Sub-Investigator: Sunny Lee, MD            
Sub-Investigator: Barbara Cavanaugh, MD            
Sub-Investigator: Frederick Fellin, MD            
Sub-Investigator: Allison Zibelli, MD            
Sub-Investigator: Tiffany Avery, MD            
Sub-Investigator: Rebecca Jaslow, MD            
Sub-Investigator: Erik Knudsen, PhD            
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Agnieszka Witkiewicz, MD Thomas Jefferson University
Principal Investigator: Gordon Schwartz, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01514565     History of Changes
Other Study ID Numbers: 11D-574
Study First Received: January 17, 2012
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Triple negative Breast Cancer
RB
PTEN
Chemotherapy
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013