Endoscopic mastectomy for breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and safety of endoscopic nipple-sparing mastectomy with immediate breast reconstruction for breast cancer patients. It focuses on women with small to medium breast sizes who require mastectomy due to specific cancer indications. The approach utilizes a single-port device to minimize scarring and reduce costs compared to robotic techniques. The study will assess various outcomes including operative time, infection rates, aesthetic results, and oncological safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women between 20 and 75 years.
* Patient with an indication for curative mastectomy, either unilateral or bilateral, with nipple preservation:

  * Extensive Carcinoma In Situ (CIS), more than 2 cm from the nipple
  * Multicentric Infiltrating Carcinoma (IC), more than 2 cm from the nipple
  * Large volume Infiltrating Carcinoma, more than 2 cm from the nipple
  * IC or CIS for which the patient refuses conservative treatment, more than 2 cm from the nipple
* Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandular ptosis not exceeding grade 2 according to Regnault's classification
* Patient wishing to undergo immediate breast reconstruction.
* WHO/OMS (World Health Organization/Organisation Mondiale de la Santé) performance status \<3

Exclusion Criteria:

* Cutaneous carcinoma
* Inflammatory breast
* History of oncological breast surgery on the same breast
* Patient who has received radiation treatment on the same breast
* Breast hypertrophy requiring a nipple-bearing flap
* Smoking ≥ 10 cigarettes/day
* BMI \> 35
* Protected patient or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP).
* Patient participating in another interventional clinical study.
* ASA (physical status score of the American Society of Anesthesiologists) \>2.
* Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
* Vulnerable persons (those receiving psychiatric care, those deprived of liberty, and those admitted to a health or social institution) according to Article L1121-6 of the CSP.
* Absence of effective contraception for patients of childbearing age.
* Absence of affiliation with a social security scheme.
* Absence of collected free, informed, and written consent.

Where it's running

• Uhmontpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Gauthier Rathat, MD
• Email: g-rathat@chu-montpellier.fr
• Phone: 467336532

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.