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NCT Number: NCT02471742

NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

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.

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Key information

Age range

23 year–77 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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). Exclusion criteria for the present study were all the other breast cancer patients, particularly T4 breast cancer with inflammatory or ulcerated breast cancer before chemotherapy and patients with synchronous distant metastases. Patients affected with other clinical diseases (i.e. cardiovascular diseases) conditioning the optimal therapeutic strategy were excluded.

For NAC-sparing mastectomy, exclusion criterions were nipple retraction, Paget's disease, inflammatory changes of the breast and bloody discharge from the nipple. The study did not exclude women with prior breast augmentation, heavy smokers, obese patients.

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Treatment and study plan

NAC-sparing mastectomy

Procedure

patients treated with mastectomy with conservation of nipple-areola complex

Conventional mastectomy

Procedure

patients treated with mastectomy without conservation of nipple-areola complex

Primary outcomes

  1. local disease free survival

    Time frame: 11 years

    this study evaluates the local safety of NAC-sparing mastectomy compared with conventional mastectomy after neoadjuvant chemotherapy

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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