A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer
Anthracycline-based chemotherapy is widely used as adjuvant treatment for breast cancer. In
addition to the challenge posed by anthracycline-induced cardiotoxicity, there are issues
surrounding previous treatment with anthracyclines which limit its utility in the metastatic
disease setting. Many patients with advanced disease will have had prior
anthracycline-based adjuvant therapy, may have reached a maximum cumulative lifetime dose,
or developed refractory disease, creating an obvious need for non-anthracycline treatment
strategies.3 Platinum- and taxane-based chemotherapies as first-line therapy for metastatic
breast cancer have demonstrated significant activity, producing single-agent response rates
> 50%; in combination these rates increased to > 60% in both previously untreated and in
patients who previously received anthracyclines.3 However, overall survival has remained
relatively unchanged.4 As there is currently no standard of care for patients with
metastatic breast cancer, various physical and psychological factors must be considered when
evaluating chemotherapy treatment options, including the patient's tumor biology and growth
rate, presence and extent of metastases, history of prior treatment and response,
sensitivity and tolerance to therapy, and quality of life.2 Strategies to develop
combination, higher dose, or sequential regimens using these active agents, while improving
response rates and/or time to progression, may produce increased toxicity without increased
survival.2 Because metastatic breast cancer remains essentially incurable using cytotoxic
therapy alone, the study of targeted biologics offers new opportunities to enhance drug
delivery via their ability to regulate specific receptors that are associated with
clinically aggressive disease processes.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of a combination regimen of weekly Abraxane® and carboplatin plus biweekly bevacizumab to treat women with Stage IV or inoperable Stage III "triple negative" metastatic breast cancer.
On-going
Yes
Kimberly Blackwell, MD
Principal Investigator
Duke University
United States: Institutional Review Board
Pro00014837
NCT00479674
May 2007
May 2016
Name | Location |
---|---|
NorthEast Oncology Associates | Concord, North Carolina 28025 |
Duke University Medical Center | Durham, North Carolina 27710 |
Forsyth Regional Cancer Center | Winston-Salem, North Carolina 27103 |
Presbyterian Health Care | Charlotte, North Carolina 28204 |