Clinical trial · Interventional
Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
Local Excision Alone for Selected Patients With DCIS of the Breast
NCT00002934CI-TRIAL-00067422terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer. PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| long-term screening | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Pathology Review, Observation and Follow-up
- description
- Pathology review, observation and follow-up
- interventionNames
- Procedure: long-term screening
Primary outcomes (1)
- measure
- Actuarial local recurrence rate
- timeFrame
- Assessed at 5 years
- description
- Rate of in situ or invasive local breast cancer recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast * No greater than 2.5 cm in the greatest dimension * OR * Histologically proven high-grade DCIS of the breast * No greater than 1 cm in greatest dimension * Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible) * DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy * Pathologically confirmed negative margins of at least 3 mm * Breast must be suitable for breast conserving therapy * Proper tumor size versus breast size * No carcinoma or suspicious mammogram findings in other breast sites * No prior in situ or invasive breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Greater than 5 years Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * Not specified Other: * No other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * No known HIV infection * No Paget's nipple disease PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Adjuvant tamoxifen allowed Radiotherapy: * No prior radiotherapy to breast * No adjuvant radiotherapy Surgery: * Not specified
References
Publications (3)
- RESULTHughes LL, Wang M, Page DL, Gray R, Solin LJ, Davidson NE, Lowen MA, Ingle JN, Recht A, Wood WC. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Nov 10;27(32):5319-24. doi: 10.1200/JCO.2009.21.8560. Epub 2009 Oct 13. PMID 19826126
- RESULTHughes L, Wang M, Page D, et al.: Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-29, S15, 2006.
- DERIVEDSolin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. J Clin Oncol. 2015 Nov 20;33(33):3938-44. doi: 10.1200/JCO.2015.60.8588. Epub 2015 Sep 14. PMID 26371148