NCT02471742

NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

Nipple Areolar-complex Sparing Mastectomy After Neo-adjuvant Chemotherapy: Evaluation of Local Oncologic Safety in a Cohort Study Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 573 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: Female
• Age: 23 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant chemotherapy, may theoretically appear suitable for this surgical option, alternative to conventional mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a good response to neoadjuvant chemotherapy has been achieved.

Detailed description

From January 2009 to May 2013, 422 BC patients were progressively accrued to NAC-sparing mastectomy, of which 361 invasive BC patients underwent NAC-sparing mastectomy as first treatment (NAC-group), whereas 61 T2-T3 invasive BC patients underwent surgery after primary chemotherapy (NAC-PC group). 151 BC patients underwent primary chemotherapy and conventional mastectomy (PC group) from 2004 to 2009, has been evaluated as comparative group respect to NAC-PC group. Using propensity score matching, local disease-free survival (LDFS) in NAC-PC patients was first compared with that in PC patients. The NAC-PC cohort was then compared to NAC patients in terms of LDFS using two different matching criteria, one with tumor size after neoadjuvant chemotherapy and one with tumor size before neoadjuvant chemotherapy as balancing covariates.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	NAC-sparing mastectomy	patients treated with mastectomy with conservation of nipple-areola complex
PROCEDURE	conventional mastectomy	patients treated with mastectomy without conservation of nipple-areola complex

Timeline

• Start date: 2004-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-06-15
• Last updated: 2015-09-16

Locations

1 site across 1 country: Italy