Therapeutic Nipple Sparing Mastectomy. (MAPAM-01)
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|ClinicalTrials.gov Identifier: NCT02311959|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2014
Last Update Posted : August 21, 2019
This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.
The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.
450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).
All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).
The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.
After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.
An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.
A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.
Data will be collected over a 3 months period after surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Nipple sparing mastectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Nipple Areola Skin-sparing Mastectomy.|
|Actual Study Start Date :||February 9, 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2025|
|Experimental: Invasive or in situ breast carcinoma.||
Procedure: Nipple sparing mastectomy
Standardized surgical procedure by :
- Local recurrence rate. [ Time Frame: 9 years. ]Annual incidence of local recurrence defined by the number of local recurrences (skin, thoracic wall and nipple) among the patient years of follow-up..
- Early and late complications [ Time Frame: 9 years. ]Early and late complications will be evaluated using NCI toxicity scale version 4.0.
- Disease free Survival. [ Time Frame: 9 years. ]
Disease-free survival is the period between the date of origin and date of the first event as defined below, or date of latest news (Censored Data).
The events included in the definition of disease-free survival are local recurrence, lymph node metastases, contralateral locations, distant metastases, second breast cancer and death from any causes.
- Metastasis Free Survival. [ Time Frame: 9 years. ]Metastasis free survival is defined as the time from inclusion until the date of metastasis recurrence or the date of the latest news (Censored data).
- Overall Survival. [ Time Frame: 9 years ]Overall survival is defined as the time from inclusion until the date of death or the date of the latest news (Censored data).
- Aesthetic evaluation. [ Time Frame: 9 years. ]The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.
- Quality of life. [ Time Frame: 9 years. ]The quality of life will be evaluated according to the Breast-Q questionnaire.
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): NCT02311959
|Principal Investigator:||Eva JOUVE, Md.||IUCT-O|