Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast

Carcinoma Breast Clinical Trial

— DCIS  

Official title:

Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002766
• Other study ID #: 67/13
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2016
• Last updated: December 21, 2016
• Start date: March 2000
• Est. completion date: April 2006

Study information

• Verified date: December 2016
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma Breast
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Procedure:
• Breast conservative surgery

Locations

Country	Name	City	State
Italy	Massimiliano Gennaro	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (28)

Benson JR, Jatoi I, Toi M. Treatment of low-risk ductal carcinoma in situ: is nothing better than something? Lancet Oncol. 2016 Oct;17(10):e442-e451. doi: 10.1016/S1470-2045(16)30367-9. Review. — View Citation

Cuzick 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 — View Citation

Donker M, Litière 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 outcom — View Citation

Early 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 — View Citation

EORTC Breast Cancer Cooperative Group.; EORTC Radiotherapy Group., Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without r — View Citation

Fisher 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 Adj — View Citation

Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast an — View Citation

Fisher ER, Dignam J, Tan-Chiu E, Costantino J, Fisher B, Paik S, Wolmark N. Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer. 1999 Aug 1;86(3):429-38. — View Citation

Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators.. Anastrozole versus tamoxifen for the prevention of locoregional and c — View Citation

Gennaro M, Ferraris C, Guida V, Tomasic G, Carcangiu ML, Greco M. Conservative surgery in breast cancer. Significance of resection margins. Breast. 2001 Oct;10(5):432-7. — View Citation

Healy C, Allen RJ Sr. The evolution of perforator flap breast reconstruction: twenty years after the first DIEP flap. J Reconstr Microsurg. 2014 Feb;30(2):121-5. doi: 10.1055/s-0033-1357272. Review. — View Citation

Holmberg 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 Cl — View Citation

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Kasem A, Wazir U, Headon H, Mokbel K. Breast lipofilling: a review of current practice. Arch Plast Surg. 2015 Mar;42(2):126-30. doi: 10.5999/aps.2015.42.2.126. Review. — View Citation

Lesurf R, Aure MR, Mørk HH, Vitelli V; Oslo Breast Cancer Research Consortium (OSBREAC)., Lundgren S, Børresen-Dale AL, Kristensen V, Wärnberg F, Hallett M, Sørlie T. Molecular Features of Subtype-Specific Progression from Ductal Carcinoma In Situ to Inva — View Citation

Macdonald HR, Silverstein MJ, Lee LA, Ye W, Sanghavi P, Holmes DR, Silberman H, Lagios M. Margin width as the sole determinant of local recurrence after breast conservation in patients with ductal carcinoma in situ of the breast. Am J Surg. 2006 Oct;192(4 — View Citation

Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep. 1966 Mar;50(3):163-70. — View Citation

Margolese RG, Cecchini RS, Julian TB, Ganz PA, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Anastrozole versus tamoxife — View Citation

Povoski SP, Jimenez RE, Wang WP, Xu RX. Standardized and reproducible methodology for the comprehensive and systematic assessment of surgical resection margins during breast-conserving surgery for invasive breast cancer. BMC Cancer. 2009 Jul 27;9:254. doi — View Citation

Rizzo M, Iyengar R, Gabram SG, Park J, Birdsong G, Chandler KL, Mosunjac MB. The effects of additional tumor cavity sampling at the time of breast-conserving surgery on final margin status, volume of resection, and pathologist workload. Ann Surg Oncol. 20 — View Citation

Rutgers EJ; EUSOMA Consensus Group.. Quality control in the locoregional treatment of breast cancer. Eur J Cancer. 2001 Mar;37(4):447-53. — View Citation

Rutqvist LE, Rose C, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in breast cancer. Acta Oncol. 2003;42(5-6):532-45. Review. — View Citation

Sagara Y, Freedman RA, Vaz-Luis I, Mallory MA, Wong SM, Aydogan F, DeSantis S, Barry WT, Golshan M. Patient Prognostic Score and Associations With Survival Improvement Offered by Radiotherapy After Breast-Conserving Surgery for Ductal Carcinoma In Situ: A — View Citation

Schwartz GF, Veronesi U, Clough KB, Dixon JM, Fentiman IS, Heywang-Köbrunner SH, Holland R, Hughes KS, Mansel RE, Margolese R, Mendelson EB, Olivotto IA, Palazzo JP, Solin LJ; Consensus Conference Committee.. Consensus conference on breast conservation. J — View Citation

Silverstein MJ, Lagios MD, Craig PH, Waisman JR, Lewinsky BS, Colburn WJ, Poller DN. A prognostic index for ductal carcinoma in situ of the breast. Cancer. 1996 Jun 1;77(11):2267-74. — View Citation

Silverstein MJ, Lagios MD. Treatment selection for patients with ductal carcinoma in situ (DCIS) of the breast using the University of Southern California/Van Nuys (USC/VNPI) prognostic index. Breast J. 2015 Mar-Apr;21(2):127-32. doi: 10.1111/tbj.12368. — View Citation

Simpson PT, Reis-Filho JS, Lambros MB, Jones C, Steele D, Mackay A, Iravani M, Fenwick K, Dexter T, Jones A, Reid L, Da Silva L, Shin SJ, Hardisson D, Ashworth A, Schmitt FC, Palacios J, Lakhani SR. Molecular profiling pleomorphic lobular carcinomas of th — View Citation

Van Zee KJ, Liberman L, Samli B, Tran KN, McCormick B, Petrek JA, Rosen PP, Borgen PI. Long term follow-up of women with ductal carcinoma in situ treated with breast-conserving surgery: the effect of age. Cancer. 1999 Nov 1;86(9):1757-67. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral Breast Tumor Recurrence (IBTR)		six years	No
Secondary	Contralateral breast cancer (CBC)	the side effects of radiotherapy may outweigh the reduction in the risk of IBTR	six years	No