Clinical trial NCT01514565: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
Official title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Triple negative Breast Cancer
RB
PTEN
Chemotherapy
Neoadjuvant
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 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.

Primary outcomes:
measure: Histological status of retinoblastoma tumour suppressor (RB)
timeFrame: Nine weeks
Secondary outcomes:
measure: Correlation of RB and other biomarkers
timeFrame: Nine weeks
measure: Determine the utility of an RB molecular test
timeFrame: Assessed within 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Agnieszka Witkiewicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Gordon Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: