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

Primary Purpose

Ductal Carcinoma in Situ of the Breast

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Observation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ductal Carcinoma in Situ of the Breast focused on measuring Ductal carcinoma in situ, DCIS, wide excision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Observation (omission of RT)

Arm Description

Wide excision of DCIS; no radiotherapy (RT).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2005
Last Updated
May 2, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00165256
Brief Title
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Official Title
Wide Excision Alone for DCIS-Grades 1 and 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1995 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma in Situ of the Breast
Keywords
Ductal carcinoma in situ, DCIS, wide excision

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation (omission of RT)
Arm Type
Experimental
Arm Description
Wide excision of DCIS; no radiotherapy (RT).
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue
Primary Outcome Measure Information:
Title
To determine if patients with DCIS can be effectively treated with wide excision alone.
Description
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 Outcome Measure Information:
Title
To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Wong, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16461781
Citation
Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.
Results Reference
result
PubMed Identifier
24346130
Citation
Wong JS, Chen YH, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Smith BL, Troyan SL, Harris JR. Eight-year update of a prospective study of wide excision alone for small low- or intermediate-grade ductal carcinoma in situ (DCIS). Breast Cancer Res Treat. 2014 Jan;143(2):343-50. doi: 10.1007/s10549-013-2813-6. Epub 2013 Dec 18.
Results Reference
result

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

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