To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruct… (NCT06817954) | Clinical Trial Compass
RecruitingNot Applicable
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
China800 participantsStarted 2025-01-01
Plain-language summary
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
✓. Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
✓. There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
✓. There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
✓. Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
✓. Preoperative clinical manifestations and imaging data showed no distant metastasis;
✓. No history of breast cancer or other serious underlying diseases in the past;
What they're measuring
1
Local recurrence free survival rate (LRFS)
Timeframe: 3 years
2
Regional recurrence free survival rate (RRFS)
Timeframe: 3 years
Trial details
NCT IDNCT06817954
SponsorThe First Affiliated Hospital with Nanjing Medical University