The following are highlights of investigator-initiated trials being sponsored by Georgia CORE. For a comprehensive listing of clinical trials in Georgia, please see http://www.georgiacancertrials.org.

Randomized Phase II Trial of Sequential Docetaxel followed by Capecitabine versus Concomitant Docetaxel/Capecitabine as Induction Therapy for Early Stage Breast Cancer

Principal Investigator: Ruth O’Regan, MD
Emory University-Winship Cancer Institute
Director of Translational Breast Cancer Research
Medical Oncology

Recent studies in patients with metastatic breast cancer (cancer that has spread beyond the breast) have shown that using a combination of two drugs, docetaxel and capecitabine, is more effective in treating breast cancer than using each drug by itself. Both drugs are FDA-approved and are commonly used in treating advanced breast cancer.

This study is designed to determine whether a combination of the two drugs will also be effective in treating early-stage breast cancer. The drugs will be administered prior to surgery. Receiving chemotherapy before surgery will show whether the patient’s tumor will respond to treatment, and shrink in size. This could allow the patient to have less extensive surgery, and preserve more of the breast.

Approximately 80 people will take part in this study.

• Winship Cancer Institute (Atlanta)
• Georgia Cancer Center for Excellence at Grady Health System (Atlanta)
• Emory Crawford Long Hospital (Atlanta)
• Augusta Oncology Associates (Augusta)
• Central Georgia Cancer Care, P.C. (Macon, Warner Robbins)
• Charles B. Eberhart Cancer Center at DeKalb Medical Center (Decatur)
• John B. Amos Cancer Center (Columbus)
• South Atlanta Hematology Oncology (East Point, Riverdale, Stockbridge)
• Suburban Hematology Oncology (Duluth, Lawrenceville, Snellville)
• Wellstar Health System- Georgia Cancer Specialists (Marietta, Austell)
• Wellstar Health System- NW Georgia Oncology Centers, P.C. (Austell, Carrollton, Marietta)

This trial is sponsored by Georgia CORE and supported by Sanofi-Aventis. If you have questions about the study, please contact Georgia CORE’s Research Director, Diane Hicklin, at dhicklin@georgiacore.org or 404-588-4082.

Multi-center, Phase III, Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Docetaxel (AC?T) with Doxorubicin and Cyclophosphamide Followed by Docetaxel and Trastuzumab (Herceptin® )(AC?TH) and with Docetaxel, Carboplatin and Trastuzumab (TCH) in the Adjuvant Treatment of Node Positive and High Risk Node Negative Patients with Operable Breast Cancer Containing the HER2 Alteration

Principal Investigator: Don W. Shaffer II, MD
Northwest Georgia Oncology Centers, P.C.

The objective of this study is to determine whether breast cancer treatment with Herceptin® (a drug made to specifically target certain kinds of cancer cells) in combination with other chemotherapy agents is better than a standard treatment that did not contain Herceptin®. This study is in the data analysis and follow-up phase and is no longer open to enrollment.

For more information on clinical trials in Georgia please visit www.georgiacancertrials.org.