Status:
ACTIVE_NOT_RECRUITING
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Ductal Carcinoma in Situ of the Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00165256
Start Date
May 1 1995
End Date
December 1 2027
Last Update
December 29 2025
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115