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NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT02471742
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : September 16, 2015
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: NAC-sparing mastectomy Procedure: conventional mastectomy

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.

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Study Type : Observational
Actual Enrollment : 573 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nipple Areolar-complex Sparing Mastectomy After Neo-adjuvant Chemotherapy: Evaluation of Local Oncologic Safety in a Cohort Study Analysis
Study Start Date : January 2004
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Group/Cohort Intervention/treatment
NAC-PC
patients treated with neoadjuvant chemotherapy and NAC-sparing mastectomy
Procedure: NAC-sparing mastectomy
patients treated with mastectomy with conservation of nipple-areola complex

NAC
patients treated NAC-sparing mastectomy and adjuvant therapy
Procedure: NAC-sparing mastectomy
patients treated with mastectomy with conservation of nipple-areola complex

PC
patients treated with neoadjuvant chemotherapy and conventional mastectomy
Procedure: conventional mastectomy
patients treated with mastectomy without conservation of nipple-areola complex




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471742


Locations
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Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, MI, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Roberto Agresti, MD Istituto Tumori Milano
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02471742    
Other Study ID Numbers: INT 177/13
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015