Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

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.

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.

Gemcitabine and Capecitabine and Avastin

Bachir Sakr, MD

William Sikov, MD

Melanie Royce, MD

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.

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.

Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse

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

6 out of 17 patients came off study for toxicity prior to receiving all 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 that lead to patients being taken off study.

Women and Infants Hospital of Rhode Island

Rhode Island Hospital

The Miriam Hospital

Memorial Hospital of Rhode Island

University of New Mexico Cancer Center

Brown University

Principal Investigator

After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.

Doses to be administered:

Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1

Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.

Gemcitabine, Capectiabine, Avastin

Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.

Doses to be administered:

Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1

Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.

Toxicity Related to Treatment

Number of Participants With Recurrent Disease

Overall Study

Spots Global Cancer Trial Database for gemcitabine and capecitabine and avastin