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Title: (IRB 08-042) WX/60-006: A Phase 2, Two-Arm, Double-Blind, Multi-Center, Randomized Study of The Combination of Oral WX-671 Plus Capecitabine VS. Capecitabine Monotherapy In First-Line Her2-Negative Metastatic Breast Cancer

Principal Investigator: Lori Goldstein, MD

Sponsors: Wilex AG and the United States Department of Defense

Summary: This Phase 2 clinical trial is designed for women with Her2-Negative metastatic breast cancer. Standard therapy for this disease is chemotherapy (capecitabine). This study will determine whether adding an investigative drug, WX-671, to the standard chemotherapy improves patient outcomes. WX-671 aims to reduce the invasive and metastatic properties of tumors and slow down their growth by blocking a certain system in the tumor.

Both drugs will be given orally instead of intravenously, which is much more convenient for patients. This international multi-site study will include 100 patients.

Clinical Research Coordinator: Kathleen Lear, RN, OCN, CCRP, Phone: 215-214-1511, e-mail: kathleen.lear@fccc.edu

Clinical Research Associate: Jiwon Kang, Phone: 215-728-3618, e-mail: Jiwon.Kang@fccc.edu


Title: (IRB06-029) A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies

Principal Investigator: Ramona Swaby, MD

Sponsors: AstraZeneca and United States Department of Defense

Summary: This Phase 2 clinical trial is designed for women with hormone receptor positive metastatic breast cancer who have been treated with previous anti-estrogen therapy. An eligible study candidate would be someone who had been treated with tamoxifen and/or arimidex, femara or aromasin either for early breast cancer or when the cancer has spread to other parts of the body. The purpose of this research study is to determine whether estrogen in the form of the drug Estrace can shrink breast cancer to induce remission. Researchers will also evaluate whether Estrace can reverse the resistance of the tumor to anti-estrogen treatments such as tamoxifen, arimidex, femara, or aromasin. Estrace is taken orally daily. This study will enroll between 40 and 80 postmenopausal women.

Clinical Research Coordinator: Cecilia McAleer, Phone: 728-2981, e-mail: ca_mcaleer@fccc.edu

Clinical Research Associate: Terry Halbherr, Phone: 215-728-4015, e-mail: tc_halbherr@fccc.edu


For more information about breast cancer treatment and prevention at Fox Chase Cancer Center or to make an appointment, call 1-888-FOX CHASE (1-888-369-2427). The breast cancer scheduling department can be reached at 215-728-3001.