Therapeutic Nipple Sparing Mastectomy.

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02311959
• Date of registration: 05/12/2014
• Prospective Registration: Yes
• Primary sponsor: Institut Claudius Regaud
• Public title: Therapeutic Nipple Sparing Mastectomy. MAPAM-01
• Scientific title: Therapeutic Nipple Areola Skin-sparing Mastectomy.
• Date of first enrolment: February 9, 2015
• Target sample size: 450
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02311959
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Eva JOUVE, Md.
• Affiliation: IUCT-O

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Procedure: Nipple sparing mastectomy

Primary Outcome(s)

Local recurrence rate. [Time Frame: 9 years.]

Secondary Outcome(s)

Quality of life. [Time Frame: 9 years.]

Aesthetic evaluation. [Time Frame: 9 years.]

Early and late complications [Time Frame: 9 years.]

Disease free Survival. [Time Frame: 9 years.]

Overall Survival. [Time Frame: 9 years]

Metastasis Free Survival. [Time Frame: 9 years.]

Secondary ID(s)

14 SEIN 10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut Paoli-Calmettes