Recruiting

Tumor Suppressor Status

Sponsor:

Thomas Jefferson University

Code:

NCT01514565

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Breast Cancer

Study ID

NCT01514565

Start date

Dec, 2011

Status verified date

Mar, 2015

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Histological status of retinoblastoma tumour suppressor (RB) [ Time Frame: Nine weeks ]

Central Contacts and Locations

Central contacts

Agnieszka Witkiewicz, MD

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

Gordon Schwartz, MD

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

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Agnieszka Witkiewicz, MD

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

Gordon Schwartz, MD

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

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 18, 2015

Last verified

Mar, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2015-03-18.