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

Phase 2Active Not RecruitingNCT00165256

Dana-Farber Cancer Institute158 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

158

Conditions

Ductal Carcinoma in Situ of the Breast

Interventions

ObservationOTHER

Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To determine if patients with DCIS can be effectively treated with wide excision alone.

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.

Time frame: TBD-survivorship

Secondary Outcomes

To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.

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.

Time frame: TBD-survivorship

Data from ClinicalTrials.gov

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