University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 1B-04-4


An International Randomized Controlled Trial to Compare Targeted Intra-Operative Radiotherapy with Conventional Post-Operative Radiotherapy after Conservative Breast Surgery for Women with Early Stage Breast Cancer.

Type: Treatment
Phase: Phase III
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Radiation: External, Surgery
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Julie Lang, M.D.
Other Trial Staff:  Jackie Major, R.N., Margarita Carranza, D.M., Ronald Rivera, D.M., America Casillas-Lopez, Coordinator

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Operable invasive breast carcinoma (T1-3 N0-1 M0) confirmed by cytological or histological exam and are suitable for breast-conserving surgery. Patients with previously diagnosed and treated contralateral breast cancer may be entered but will be randomized to a separate stratum. Patients at high risk of recurrence elsewhere in the breast, e.g., lobular carcinoma and extensive intraductal component, are eligible with the addition of whole breast RT.
2Females at least 35 years old.
3Available for regular follow-up for at least 10 years.
4Signed informed consent (including HIPAA authorization).


You may not participate in this study if:
1More than one obvious cancer in the same breast as diagnosed by clinical exam, mammography, or ultrasonography.
2Bilateral breast cancer at the time of diagnosis.
3Extensive lobular carcinoma or EIC on core biopsy or initial pathology (if performed).
4Undergoing primary medical treatment (hormones or chemotherapy) as initial treatment of invasive breast cancer.
5Presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning.
6Any severe concomitant disease that may limit life expectancy. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is at least 90%.



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.