Phase II Neoadjuvant Trial With Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response rate (pCR) at the time of definitive
surgery.
SECONDARY OBJECTIVES:
I. Determination of the clinical response rate, as measured by clinical exam and imaging
studies prior to initiation of therapy and prior to surgery.
II. Measurement of alpha B-crystalline in tissue obtained before initiation of therapy and
at the time of definitive surgery.
III. Stem cell markers (cluster of differentiation [CD]44+, CD24-, CD133, aldehyde
dehydrogenase 1 [ALDH1] and evaluation of the NOTCH pathway) in tissue obtained before
initiation of therapy and at the time of definitive surgery.
IV. Measurement of proliferation markers (Ki67) before and after treatment in tissue
obtained before imitation of therapy and at the time of definitive surgery.
V. Measurement of beta III tubulin in tissue obtained before initiation of therapy and at
the time of definitive surgery.
VI. Measurement of Tau in tissue obtained before initiation of therapy and at the time of
definitive surgery.
VII. Safety evaluation, including following of patients for alopecia and neuropathy.
VIII. Epidermal growth factor receptor (EGFR) staining before and after treatment in tissue
obtained before initiation of therapy and at the time of definitive surgery.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes and carboplatin IV
over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the pathologic complete response rate (pCR).
Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)
No
Virginia Kaklamani, MD
Principal Investigator
Northwestern University
United States: Institutional Review Board
NU 10B07
NCT01372579
August 2011
June 2018
Name | Location |
---|---|
Northwestern University | Chicago, Illinois 60611 |