NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

NCT02471742 | Completed

• 1 other identifier: INT 177/13
• Study Type: observational
• Target: 573
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• local disease free survival

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

  11 years

Study Arms (3)

NAC-PC

patients treated with neoadjuvant chemotherapy and NAC-sparing mastectomy

Procedure: NAC-sparing mastectomy

NAC

patients treated NAC-sparing mastectomy and adjuvant therapy

Procedure: NAC-sparing mastectomy

PC

patients treated with neoadjuvant chemotherapy and conventional mastectomy

Procedure: conventional mastectomy

Interventions

NAC-sparing mastectomy PROCEDURE

patients treated with mastectomy with conservation of nipple-areola complex

NAC; NAC-PC

conventional mastectomy PROCEDURE

patients treated with mastectomy without conservation of nipple-areola complex

PC

Eligibility Criteria

• Age: 23 Years - 77 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both the population of patients treated with neoadjuvant chemotherapy (NAC-PC and PC groups) were T2-T3 N0-N1 breast cancer. The population of patients who underwent NAC-sparing mastectomy as primary therapy (NAC-group) were T1-T3 N0-1 M0 breast cancer patients.

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI, 20133, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roberto Agresti, MD

  Istituto Tumori Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2004
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

IT (1)