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A Phase II Study of AZD0530 in Hormone-Receptor-Negative Metastatic Breast Cancer or Unresectable Locally Advanced Breast Cancer
[Protocol 07-112]
- Full Title :
- A PHASE II STUDY OF AZD0530 IN HORMONE RECEPTOR-NEGATIVE METASTATIC BREAST CANCER (NCI #7567)
- Purpose :
Recurrent hormone receptor-negative breast cancer can be difficult to treat. Hormonal therapies such as tamoxifen or aromatase inhibitors do not work in this type of breast cancer. Standard chemotherapy drugs can cause side effects, and the duration of their benefit may not be as long as one would hope. As a result, new therapies are needed.
AZD0530 is an investigational targeted therapy that attacks specific proteins (such as "Src") in cells. Research studies in the laboratory suggest that Src function may be abnormal in some patients with breast cancer. The purpose of this study is to evaluate the safety and effectiveness of AZD0530 treatment in women with hormone receptor-negative metastatic or locally advanced breast cancer. Researchers hope that daily AZD0530 treatment will inhibit Src function, potentially shrinking tumors or slowing their growth. AZD0530 is a pill that is taken orally (by mouth).
- 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 hormone receptor-negative breast cancer that is unresectable (cannot be surgically removed) locally advanced disease or metastatic disease.
- Patients with metastatic disease may have had up to one prior regimen of chemotherapy for advanced disease. Patients with locally advanced unresectable disease must have experienced continued cancer growth despite one initial chemotherapy regimen. Patients whose tumors are HER2-positive must have experienced disease progression despite trastuzumab therapy.
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Clifford Hudis at 646-888-5449 or Dr. Tiffany A. Traina at 646-888-5209.
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