NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471742
• Other study ID #: INT 177/13
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: September 15, 2015
• Start date: January 2004
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 77 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• NAC-sparing mastectomy
patients treated with mastectomy with conservation of nipple-areola complex
• conventional mastectomy
patients treated with mastectomy without conservation of nipple-areola complex

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

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