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Details for trial 1B-04-4

Description:	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.
Status:	Open
Randomized?	Yes

Researchers

Principal Investigator	Title
Dennis Holmes	M.D.

Data Management

Name	Title
Jackie Major	R.N.
Ronald Rivera	D.M.

You may participate in this study if:

	Requirement
1	Operable 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.
2	Females at least 35 years old.
3	Available for regular follow-up for at least 10 years.
4	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	More than one obvious cancer in the same breast as diagnosed by clinical exam, mammography, or ultrasonography.
2	Bilateral breast cancer at the time of diagnosis.
3	Extensive lobular carcinoma or EIC on core biopsy or initial pathology (if performed).
4	Undergoing primary medical treatment (hormones or chemotherapy) as initial treatment of invasive breast cancer.
5	Presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning.
6	Any 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, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.