Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

- 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.

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.