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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
Sponsor:
Collaborator:
Institut Paoli-Calmettes
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE December 5, 2014
First Posted Date  ICMJE December 9, 2014
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE February 9, 2015
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
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..
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02311959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Nipple Sparing Mastectomy.
Official Title  ICMJE Therapeutic Nipple Areola Skin-sparing Mastectomy.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Procedure: Nipple sparing mastectomy

Standardized surgical procedure by :

  • Nipple sparing mastectomy with nipple core histopathology.
  • Immediate breast reconstruction (flap and/or implant).
  • +/- lymph node evaluation (sentinel node procedure or axillary dissection).
Study Arms  ICMJE Experimental: Invasive or in situ breast carcinoma.
Intervention: Procedure: Nipple sparing mastectomy
Publications * Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 5, 2014)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with invasive breast carcinoma stage T1 or T2 and / or in situ (any histological type) proved on histopathological diagnosis.
  • Patient with an indication of total mastectomy.
  • Patient without preoperative indication of adjuvant radiotherapy according to regional and / or national guidelines.
  • Disease located more than 2 cm from the nipple after complete clinical and radiologic breast evaluation (mammography, ultrasound +/- MRI).
  • Initial breast cancer or recurrence.
  • Patient wishing to receive immediate breast reconstruction.
  • WHO performance < or = 2.
  • Patient older than 40 years.
  • For patients of childbearing age, use an effective contraceptive methods for the duration of the study.
  • For patients of childbearing potential, negative pregnancy test available before inclusion.
  • Patient affiliated to a social health insurance in France.
  • Patient who signed informed consent before enrollment in the study and before any specific procedure for the study.

Exclusion Criteria :

  • Positive node on physical examination or proved by cytology.
  • Combination of 2 predictive factors of postoperative radiotherapy : macroscopic multifocal, grade 2 or 3, vascular emboli, overexpressed HER2 (human epidermal growth factor receptor-2), triple negative (Estrogen Receptor, Progesterone Receptor and HER2 negative).
  • Neoadjuvant treatment for the current disease.
  • Patient with bilateral breast cancer.
  • Paget disease.
  • T3 or T4 carcinoma.
  • Metastatic breast cancer (disease staging realized according to national or regional guidelines).
  • Breast hypertrophy requiring a nipple support flap.
  • Nursing or pregnant woman.
  • Patient participating in any other interventional clinical study.
  • Any psychological, familial, geographic or social situation not to comply with medical monitoring and/or procedures in the study protocol.
  • Patient protected by law.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02311959
Other Study ID Numbers  ICMJE 14 SEIN 10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Institut Paoli-Calmettes
Investigators  ICMJE
Principal Investigator: Eva JOUVE, Md. IUCT-O
PRS Account Institut Claudius Regaud
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP