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Details for trial 1B-06-9

Description:	Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (TARGIT-DCIS Trial): Use of Mammography and Breast MRI to Identify Candidates for IORT.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Dennis Holmes	M.D.

Data Management

Name	Title
Kristy Watkins	R.N.
Yvonne Flores	D.M.
Jackie Major	R.N.
Margarita Carranza	D.M.

You may participate in this study if:

	Requirement
1	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
2	Female sex
3	Age greater than or equal to 40 years
4	Localized ductal carcinoma in situ
5	Clinically and/or histologically negative axillary lymph nodes
6	No imaging or clinical findings suggestive of invasive carcinoma
7	Cohort 1 (Immediate IORT group) a. Localized DCIS measuring less than or equal to 4 cm on preoperative imaging
8	Cohort 2 (Delayed IORT group) a. Localized DCIS measuring less than or equal to 4 cm or less on surgical pathology i. Delayed IORT could be performed for the explicit purpose of administering IORT or performed following re-excision of a previously operated breast to achieve clear surgical margins. ii. This cohort includes patients who were excluded from immediate IORT based on pre-operative imaging suggesting ineligibility for immediate IORT, but who are subsequently found to meet histological criteria (localized DCIS less than or equal to 4 cm and no invasive cancer) for IORT based on surgical pathology. iii. Unifocal microinvasive (T1mic or invasive focus less than or equal to 1mm in maximal diameter) is allowed following initial WLE if surgical pathology margins were greater than or equal to 2 mm for both the invasive and non-invasive components. iv. Delayed IORT must be performed within 3 months of initial WLE
9	Cohort 3 a. Subjects who received IORT at the time of initial WLE but whose surgical pathology showed them to be unsuitable candidates for IORT alone on the basis of: i. DCIS measuring greater than 5 cm on surgical pathology. ii. T1a (>1 mm) or larger invasive carcinoma associated with extensive DCIS. b. Surgical margins width <1 mm.

You may not participate in this study if:

1	Male sex
2	Age <40
3	DCIS associated with any evidence of microinvasion or invasive carcinoma on pre-operative imaging or core biopsy of the breast or axillary nodes
4	DCIS that is multicentric in the ipsilateral breast. Multicentricity will be defined at 2 or more lesions separated by more than 3 cm in the same breast
5	Non-epithelial breast malignancies such as sarcoma or lymphoma
6	DCIS associated with diffuse suspicious or indeterminate microcalcifications
7	Pregnancy or lactation
8	Collagen vascular diseases, including Systemic lupus erythematosus, Systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies), polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis
9	Serious psychiatric or addictive disorders

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.