Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative 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. Identifier: NCT01514565
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Thomas Jefferson University

January 17, 2012
January 23, 2012
March 18, 2015
December 2011
December 2015   (Final data collection date for primary outcome measure)
Histological status of retinoblastoma tumour suppressor (RB) [ Time Frame: Nine weeks ]
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.
Same as current
Complete list of historical versions of study NCT01514565 on Archive Site
  • Correlation of RB and other biomarkers [ Time Frame: Nine weeks ]
    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 ]
    Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.
Same as current
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Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
This is a prospective observational study aimed to validate biomarkers that predict response.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
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.
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2018
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Thomas Jefferson University
Thomas Jefferson University
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Principal Investigator: Agnieszka Witkiewicz, MD Thomas Jefferson University
Principal Investigator: Gordon Schwartz, MD Thomas Jefferson University
Thomas Jefferson University
March 2015