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NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 11, 2015
First Posted Date June 15, 2015
Last Update Posted Date September 16, 2015
Study Start Date January 2004
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy
Official Title Nipple Areolar-complex Sparing Mastectomy After Neo-adjuvant Chemotherapy: Evaluation of Local Oncologic Safety in a Cohort Study Analysis
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Breast Cancer
Intervention
  • Procedure: NAC-sparing mastectomy
    patients treated with mastectomy with conservation of nipple-areola complex
  • Procedure: conventional mastectomy
    patients treated with mastectomy without conservation of nipple-areola complex
Study Groups/Cohorts
  • NAC-PC
    patients treated with neoadjuvant chemotherapy and NAC-sparing mastectomy
    Intervention: Procedure: NAC-sparing mastectomy
  • NAC
    patients treated NAC-sparing mastectomy and adjuvant therapy
    Intervention: Procedure: NAC-sparing mastectomy
  • PC
    patients treated with neoadjuvant chemotherapy and conventional mastectomy
    Intervention: Procedure: conventional mastectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 12, 2015)
573
Original Actual Enrollment Same as current
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
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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Sex/Gender
Sexes Eligible for Study: Female
Ages 23 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02471742
Other Study ID Numbers INT 177/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators Not Provided
Investigators
Principal Investigator: Roberto Agresti, MD Istituto Tumori Milano
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date September 2015