Clinical trial · Interventional
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Wide Excision Alone for DCIS-Grades 1 and 2
NCT00165256CI-TRIAL-00116199completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ of the Breast | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Observation (omission of RT)
- description
- Wide excision of DCIS; no radiotherapy (RT).
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- To determine if patients with DCIS can be effectively treated with wide excision alone.
- timeFrame
- TBD-survivorship
- 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.
Secondary outcomes (1)
- measure
- To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTWong 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. PMID 16461781
- RESULTWong 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. PMID 24346130