Clinical trial · Interventional
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast.
NCT03002766CI-TRIAL-00025267DCIScompletedPhase 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)
By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins. Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.
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 |
|---|---|---|---|
| Carcinoma Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast conservative surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ipsilateral Breast Tumor Recurrence (IBTR)
- timeFrame
- six years
Secondary outcomes (1)
- measure
- Contralateral breast cancer (CBC)
- timeFrame
- six years
- description
- the side effects of radiotherapy may outweigh the reduction in the risk of IBTR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years; * female candidate to breast conservative surgery Exclusion Criteria: * female with previous omolateral or controlateral breast cancer; * female with previous radiotherapy (RT).
References
Publications (28)
- BACKGROUNDKaplan EL, Meier P. Nonparametric estimation from incomplete observations. J AM Stat Assoc 53:457-481, 1958.
- RESULTFisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441. PMID 9469327
- RESULTDonker M, Litiere S, Werutsky G, Julien JP, Fentiman IS, Agresti R, Rouanet P, de Lara CT, Bartelink H, Duez N, Rutgers EJ, Bijker N. Breast-conserving treatment with or without radiotherapy in ductal carcinoma In Situ: 15-year recurrence rates and outcome after a recurrence, from the EORTC 10853 randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4054-9. doi: 10.1200/JCO.2013.49.5077. Epub 2013 Sep 16. PMID 24043739
- RESULTHolmberg L, Garmo H, Granstrand B, Ringberg A, Arnesson LG, Sandelin K, Karlsson P, Anderson H, Emdin S. Absolute risk reductions for local recurrence after postoperative radiotherapy after sector resection for ductal carcinoma in situ of the breast. J Clin Oncol. 2008 Mar 10;26(8):1247-52. doi: 10.1200/JCO.2007.12.7969. Epub 2008 Feb 4. PMID 18250350
- RESULTEarly Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039. PMID 20956824
- RESULTCuzick J, Sestak I, Pinder SE, Ellis IO, Forsyth S, Bundred NJ, Forbes JF, Bishop H, Fentiman IS, George WD. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. Lancet Oncol. 2011 Jan;12(1):21-9. doi: 10.1016/S1470-2045(10)70266-7. Epub 2010 Dec 7.