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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02471742

Enrollment

573

Registered

2015-06-15

Start date

2004-01-31

Completion date

2015-05-31

Last updated

2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

PROCEDURENAC-sparing mastectomy

patients treated with mastectomy with conservation of nipple-areola complex

PROCEDUREconventional mastectomy

patients treated with mastectomy without conservation of nipple-areola complex

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

23 Years to 77 Years

Healthy volunteers

Inclusion criteria

T2-T3 N0-N1 breast cancer (NAC-PC and PC groups). T1-T3 N0-1 M0 breast cancer (NAC-group) In our series of NAC-sparing mastectomy patients, with or without treatment with neo-adjuvant chemotherapy, the selection of patients for NAC-sparing mastectomy has been made on the basis of the following criterions: tumor nodule without adherence to the skin, no nipple retraction, retroareolar main duct free for neoplastic tissue inside at frozen section examination. Furthermore, patients were considered still eligible for NAC-sparing mastectomy even if the tumor lies in close proximity (\<1 cm) to the NAC at physical and radiological examination.

Exclusion criteria

(NAC-PC and PC groups).

Design outcomes

Primary

Measure	Time frame	Description
local disease free survival	11 years	this study evaluates the local safety of NAC-sparing mastectomy compared with conventional mastectomy after neoadjuvant chemotherapy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026