Radiation Oncology Clinical Trials

Research Study: Phase I/II Partial Breast Irradiation with
Concurrent Chemotherapy

Do you have Breast Cancer?

Standard chemotherapy and radiation can last more than 6 months. This long course of treatment can cause you to lose time from work and family and seriously decrease your quality of life. Faster and easier treatments are needed and may be on the way. We are conducting a study in which the total course of chemotherapy and radiation for breast cancer is decreased from approximately 6 months to less than 2 months! We are currently seeking women with newly diagnosed breast cancer to participate in this study.

What is the background for this research study?
Studies have shown that a lumpectomy (or breast conserving therapy) is as effective a treatment as mastectomy for many women with breast cancer, but almost all women having lumpectomy need daily radiation treatments for 5 to 7 weeks following their surgery.

Unfortunately, many women choose to have a mastectomy because of the difficulty and inconvenience of 7 weeks of daily radiation. New techniques for shortening the length of radiation treatments are being tested in order to allow women greater freedom to choose the therapy that best reflects their desires.
At Johns Hopkins, we are investigating the use of partial breast irradiation for patients who would be candidates for breast conserving therapy (lumpectomy). With this approach only part of the breast is treated. Because a smaller area is receiving the radiation, a larger dose of radiation can be given each day. This allows patients to receive the same effective dose of radiation in a shorter period of time. In this study, radiation is given daily (weekends not included) for 3 weeks.

What is the purpose of this research study?
The purpose of this research study is to evaluate the side effects and effectiveness of treating only part of the breast with full dose radiation while also receiving chemotherapy.

Who is eligible for this study?
Women with newly diagnosed breast cancer who are candidates for breast conservation therapy (lumpectomy) and will be receiving Adriamycin and Cytoxan chemotherapy may participate in this study. Patients may also receive additional chemotherapy after completing their radiation therapy and Adriamycin/Cytoxan treatments if that has been recommended by their medical oncologist.

What is involved in this study?

After a consent form is signed, a special PET/CT or CT will be obtained to plan the radiation. The radiation may be started within 2 days of your chemotherapy and will last a total of 15 treatments (3 weeks). The chemotherapy, given with radiation, will be delivered once every two weeks for a total of 4 times. This course of therapy (radiation and concurrent chemotherapy) will last 7 weeks. You will be evaluated for side effects twice a week during radiation and once a week until the completion of chemotherapy. After the chemotherapy is complete you will be asked to return for a follow-up on our routine schedule, every 3 - 6 months for 5 years then annually afterwards.

Who can I contact to get more information about this study? 

Please call (410) 614-3158 for more information.

PI: Richard Zellars, MD
Protocol Number: J0381