Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse
Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer. While current research has shown that survival is the same whether women are treated with chemotherapy first or surgery first for breast cancer, the investigators do not yet know how to treat women with persistent breast cancer after she has received primary chemotherapy. This study looks at the use of a combination regimen of two agents (gemcitabine and capecitabine), both of which are active in breast cancer, and using Avastin to see if this regimen can be given to women treated with primary chemotherapy and then surgery, considered to be at high risk of relapse.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To monitor the rate of recurrent disease, either local this population. [ Time Frame: 6 months and again at the end of the study (1 year) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine and Capecitabine and Avastin
Avastin administered concurrently with chemotherapy (Gemcitabine + Capecitabine) for six cycles followed by single agent Avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.
Drug: Gemcitabine and Capecitabine and Avastin
avastin administered concurrently with chemotherapy (gemcitabine + capecitabine) for six cycles followed by single agent avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.
Other Name: Gemzar, Xeloda, Bevacizumab
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.
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|Women & Infants' Hospital|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Bachir Sakr, MD||Women & Infants' Hospital of Rhode Island|
|Principal Investigator:||William Sikov, MD||Lifespan Hospitals|
|Principal Investigator:||Melanie Royce, MD||University of New Mexico Cancer Center|