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A Phase III Trial of Hormonal Therapy Alone or with Bevacizumab in Women with Locally Advanced or Metastatic Hormone-Receptor-Positive Breast Cancer
[Protocol 08-094]
- Full Title :
- ENDOCRINE THERAPY IN COMBINATION WITH ANTI-VEGF THERAPY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III TRIAL OF ENDOCRINE THERAPY ALONE OR ENDOCRINE THERAPY PLUS BEVACIZUMAB (NSC 704865; IND 7921) FOR WOMEN WITH HORMONE RECEPTOR-POSITIVE ADVANCED BREAST CANCER (CALGB 40503)
- Purpose :
Standard hormonal therapy for breast cancer includes drugs such as tamoxifen or an aromatase inhibitor (such as letrozole). A newer anticancer drug called bevacizumab appears to help control breast cancer in some patients by stopping the growth of blood vessels to the tumor. Bevacizumab plus chemotherapy is commonly used to treat patients with metastatic breast cancer. Laboratory studies suggest that drugs such as bevacizumab may increase the effectiveness of standard hormonal treatments for controlling breast cancer.
The purpose of this study is to determine whether adding bevacizumab to standard hormonal therapy can improve the effectiveness of hormonal therapy alone. Patients will be randomly assigned to receive hormonal therapy with bevacizumab or a placebo, and researchers will compare the two groups.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of estrogen receptor- or progesterone receptor-positive advanced breast cancer (stage IV, or stage IIIB disease not amenable to local therapy).
- Patients must be postmenopausal. Premenopausal women may participate if they have had an oophorectomy or take medication (such as an LH-RH agonist) to suppress their ovarian function.
- Patients may not have received chemotherapy for metastatic disease nor prior anti-VEGF therapies (the class of drugs to which bevacizumab belongs). Patients must have recovered from the side effects of previous therapies.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Maura Dickler at 646-888-5456.
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