Adjuvant Bevacizumab and Chemotherapy for High-risk Breast Cancer
Name of the Trial
Phase III Randomized Study of Adjuvant Therapy Comprising Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel with Versus without Bevacizumab in Patients with Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (ECOG-E5103). See the protocol summary.
Dr. Kathy Miller and Dr. Ramona Swaby, Eastern Cooperative Oncology Group; Dr. Donald Northfelt, North Central Cancer Treatment Group; and Dr. Chau Dang, Cancer and Leukemia Group B
Why This Trial Is Important
Women with breast cancer that is removed by surgery often receive postsurgical (adjuvant) chemotherapy and radiation therapy if they are deemed to have a high risk for recurrence. High-risk breast cancers are those that have spread to nearby axillary lymph nodes (lymph node-positive cancer) or those that have not spread but have other characteristics (such as large tumor size, absence of hormone receptors, or high tumor grade) that make them more likely to recur (high-risk, lymph node-negative cancer).
Adjuvant chemotherapy has greatly improved the survival of patients with high-risk breast cancer and has contributed to increasing cure rates. However, many patients still experience recurrence of their cancer. Doctors want to find new ways to prevent or delay the recurrence of breast cancer.
One approach to improving treatment for several types of cancer has been to target the growth of new blood vessels (angiogenesis) to tumors. The antibody bevacizumab (Avastin) inhibits angiogenesis by blocking the activity of VEGF, a protein secreted by many cancer cells that spurs the growth of blood vessels to tumors.
In this trial, patients with lymph node-positive or high-risk, lymph node-negative breast cancer who have received radiation therapy or plan to do so following chemotherapy will be treated with adjuvant chemotherapy and randomly assigned to receive short-term treatment with bevacizumab, long-term treatment with bevacizumab, or treatment with an intravenous placebo. The researchers want to see if either bevacizumab regimen prevents or delays the recurrence of high-risk breast cancer better than adjuvant chemotherapy and radiation therapy alone.
"In women with metastatic breast cancer, adding bevacizumab to chemotherapy doubled responses and also led to longer durations of response," said Dr. Miller. "We think that antiangiogenesis therapy should be more effective in earlier stages of cancer, and this trial is designed to directly test that hypothesis," she added.