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

Dana-Farber Cancer Institute

Status and phase

Active, not recruiting

Phase 2

Conditions

Ductal Carcinoma in Situ of the Breast

Treatments

Other: Observation

Study type

Interventional

Funder types

Other

Identifiers

NCT00165256

94-151

Details and patient eligibility

About

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.

Full 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.

Enrollment

158 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.