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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

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

Condition or disease
Breast Cancer

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
Study Start Date : December 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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.

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 identifier (NCT number): NCT01514565

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Contact: Agnieszka Witkiewicz, MD 215-955-3778
Contact: Gordon Schwartz, MD 215-955-6999

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United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Agnieszka Witkiewicz, MD    215-955-3778   
Contact: Gordon Schwartz, MD    215-955-6999   
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
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Principal Investigator: Agnieszka Witkiewicz, MD Thomas Jefferson University
Principal Investigator: Gordon Schwartz, MD Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT01514565    
Other Study ID Numbers: 11D-574
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Thomas Jefferson University:
Triple negative Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases