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Search / Trial NCT02471742

NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Jun 12, 2015

Trial Information

Current as of August 31, 2025

Completed

Keywords

ClinConnect Summary

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 patie...

Gender

FEMALE

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:
  • (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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About Fondazione Irccs Istituto Nazionale Dei Tumori, Milano

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano is a leading cancer research and treatment institution in Italy, dedicated to advancing the understanding and management of oncological diseases. As a prominent clinical trial sponsor, the foundation focuses on innovative research aimed at developing new therapeutic strategies and improving patient outcomes. With a commitment to translational medicine, it collaborates with a network of national and international partners to facilitate cutting-edge clinical trials, enhance cancer care, and contribute to the global body of oncological knowledge.

Locations

Milan, Mi, Italy

Patients applied

0 patients applied

Trial Officials

Roberto Agresti, MD

Principal Investigator

Istituto Tumori Milano

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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