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

NCT01514565 | Unknown

• 1 other identifier: 11D-574
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Triple negative Breast Cancer; RB; PTEN; Chemotherapy; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Correlation of RB and other biomarkers

  Nine weeks

• Determine the utility of an RB molecular test

  Assessed within 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Agnieszka Witkiewicz, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Gordon Schwartz, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Witkiewicz, MD

CONTACT

215-955-3778; Agnieszka.Witkiewicz@jefferson.edu

Gordon Schwartz, MD

CONTACT

215-955-6999; Gordon.Schwartz@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (1)