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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01514565
• Other study ID #: 11D-574
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2012
• Last updated: March 17, 2015
• Start date: December 2011
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: Thomas Jefferson University
• Contact: Agnieszka Witkiewicz, MD
• Phone: 215-955-3778
• Email: Agnieszka.Witkiewicz[@]jefferson.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological status of retinoblastoma tumour suppressor (RB)	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.	Nine weeks	No
Secondary	Correlation of RB and other biomarkers	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)	Nine weeks	No
Secondary	Determine the utility of an RB molecular test	Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.	Assessed within 1 year	No