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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
Carryl Du Bois
D.M.
Carryl Du Bois
D.M.
Jackie Major
R.N.
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.
