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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Histological status of retinoblastoma tumour suppressor (RB)

Outcome Description:

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.

Outcome Time Frame:

Nine weeks

Safety Issue:


Principal Investigator

Agnieszka Witkiewicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

December 2018

Related Keywords:

  • Breast Cancer
  • Triple negative Breast Cancer
  • RB
  • PTEN
  • Chemotherapy
  • Neoadjuvant
  • Breast Neoplasms



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541