- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02471742
NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy
Nipple Areolar-complex Sparing Mastectomy After Neo-adjuvant Chemotherapy: Evaluation of Local Oncologic Safety in a Cohort Study Analysis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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MI
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Milan, MI, Italy, 20133
- Fondazione IRCCS Istituto Nazionale Tumori
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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NAC-PC
patients treated with neoadjuvant chemotherapy and NAC-sparing mastectomy
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patients treated with mastectomy with conservation of nipple-areola complex
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NAC
patients treated NAC-sparing mastectomy and adjuvant therapy
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patients treated with mastectomy with conservation of nipple-areola complex
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PC
patients treated with neoadjuvant chemotherapy and conventional mastectomy
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patients treated with mastectomy without conservation of nipple-areola complex
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local disease free survival
Time Frame: 11 years
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this study evaluates the local safety of NAC-sparing mastectomy compared with conventional mastectomy after neoadjuvant chemotherapy
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11 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Roberto Agresti, MD, Istituto Tumori Milano
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- INT 177/13
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