A Phase II Study of Adjuvant Gemcitabine/Capecitabine and Bevacizumab for Patients Treated Neoadjuvantly Chemotherapy for Early Stage Breast Cancer With High Risk for Relapse
For patients with locally advanced breast cancers (LABC) primary or neoadjuvant chemotherapy
(NAC) has become accepted as standard treatment. Advantages of NAC include shrinking the
primary tumor, often rendering an unresectable cancer resectable, and the theoretically
concurrent treatment of occult metastatic disease prior to definitive local therapy (surgery
+/- radiation therapy). NAC can reduce the extent of surgery required for the management of
local breast cancer from mastectomy to lump- or segmentectomy, without compromising major
outcome measures, such as overall and disease free survival. At this time, the current
standard of care for women felt to be candidates for NAC is an anthracycline + taxane
regimen. The intent is to induce a pCR which as noted above is a strong indicator of
survival. Yet, in both large NSABP studies, the proportion of women achieving this is less
than 20% with these regimens raising a major challenge in clinical practice: what is the
appropriate treatment for women with persistent disease after NAC? Given that gemcitabine
and capecitabine are non-cross-resistant to anthracyclines and taxanes and use a different
mechanism of action, have an acceptable toxicity profile, and in the absence of standard
options for therapy we are interested in utilizing these agents coupled with bevacizumab as
adjuvant treatment in women with residual breast cancer following primary chemotherapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy.
1 year
Yes
Bachir Sakr, MD
Principal Investigator
Women & Infants' Hospital of Rhode Island
United States: Institutional Review Board
BrUOG BR-213
NCT00462865
November 2007
May 2013
Name | Location |
---|---|
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Women & Infants' Hospital | Providence, Rhode Island 02905 |
Lifespan Hospitals | Providence, Rhode Island 02903 |