Wide Excision Alone As Treatment for Ductal Carcinoma in Situ of the Breast

Phase 2

Active, not recruiting

Brief Summary: The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

Detailed Description: * Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.

* Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.

Recruitment & Eligibility

Inclusion Criteria

Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.
A specimen radiograph is required. If the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.
The clinical extent of DCIS must be less than or equal to 2.5 cm.
Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible. Negative margins are not required on the LCIS.
Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.
Patients must be enrolled on this protocol within 3 months of the last surgical procedure.

Exclusion Criteria

Patients with invasive carcinoma including microinvasive disease
Carcinoma found in the sampled lymph nodes if axillary dissection is done
Patients with nipple discharge
Patients with adjuvant chemotherapy or Tamoxifen
Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.

Arm && Interventions

Group	Intervention	Description
Observation (omission of RT)	Observation	Wide excision of DCIS; no radiotherapy (RT).

Primary Outcome Measures

Name	Time	Method
To determine if patients with DCIS can be effectively treated with wide excision alone.	TBD-survivorship	Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated.

Secondary Outcome Measures

Name	Time	Method
To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.	TBD-survivorship	Using information gathered from follow-up physical examinations and mammography, the exploration of breast recurrences between grade 2 DCIS and grade 1 DCIS patients will be evaluated.

Locations (2): Dana-Farber Cancer Institute
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Boston, Massachusetts, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States

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