Breast Cancer
Conditions
Keywords
Endoscopic-assisted mastectomy and immediate breast reconstruction
Brief 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.
Interventions
PROCEDUREendoscopic-assisted mastectomy and immediate breast reconstruction
endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
PROCEDUREmastectomy and immediate breast reconstruction
conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients; 2. 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; 3. There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex; 4. There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery; 5. Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups); 6. Preoperative clinical manifestations and imaging data showed no distant metastasis; 7. No history of breast cancer or other serious underlying diseases in the past; 8. Karnofsky performance status score ≥ 70; 9. Eastern Cooperative Oncology Group score ≤ 2 ; 10. The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction; 11. Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up; 12. No swallowing difficulties; No shoulder joint movement disorders; 13. Complete clinical data.
Exclusion criteria
1. Male breast cancer or inflammatory breast cancer; 2. Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC; 3. The clinical data is basically incomplete; 4. Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital; 5. Bilateral breast cancer surgery; 6. Other surgical methods; 7. Preoperative distant metastasis or supraclavicular lymph node dissection; 8. Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years; 9. The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state; 10. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence free survival rate (LRFS) | 3 years | Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site. |
| Regional recurrence free survival rate (RRFS) | 3 years | Regional recurrence refers to the recurrence in the drainage area of ipsilateral internal mammary lymph nodes, axillary lymph nodes, or supraclavicular and infraclavicular lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | 3 years | The time from entry into the study to the first tumor recurrence or metastasis, or death of the subject for any reason. |
| Distant metastasis free survival rate (DMFS) | 3 years | Distant transfer refers to the transfer to any other location. |
| Main complication rate | 3 years | The Clavien-Dindo classification of surgical complications, including long term outcomes and short term outcomes. |
Countries
China
Contacts
CONTACTQiang Ding, Professor
Outcome results
None listed