Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT01514565
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University. Recruitment status was: Recruiting
This is a prospective observational study aimed to validate biomarkers that predict response.
Condition or disease
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.
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 :
Correlation of RB and other biomarkers [ Time Frame: Nine weeks ]
Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.