NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

NCT ID: NCT02471742

Last Updated: 2015-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 573 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NAC-PC

patients treated with neoadjuvant chemotherapy and NAC-sparing mastectomy

NAC-sparing mastectomy

Intervention Type: PROCEDURE

patients treated with mastectomy with conservation of nipple-areola complex

NAC

patients treated NAC-sparing mastectomy and adjuvant therapy

NAC-sparing mastectomy

Intervention Type: PROCEDURE

patients treated with mastectomy with conservation of nipple-areola complex

PC

patients treated with neoadjuvant chemotherapy and conventional mastectomy

conventional mastectomy

Intervention Type: PROCEDURE

patients treated with mastectomy without conservation of nipple-areola complex

Interventions

NAC-sparing mastectomy

patients treated with mastectomy with conservation of nipple-areola complex

Intervention Type: PROCEDURE

conventional mastectomy

patients treated with mastectomy without conservation of nipple-areola complex

Intervention Type: PROCEDURE

Eligibility Criteria

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

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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• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Agresti, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Tumori Milano

Locations

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI, Italy

Countries

Italy

Other Identifiers

INT 177/13

Identifier Type: -

Identifier Source: org_study_id