Breast cancer
Conditions
Interventions
Group A:None
Group B:none
Group C:none
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Enrollment Criteria for Group A+C: (1) Females aged 18-70 (including 18 and 70 years old); (2) Preoperative pathological confirmation of invasive breast cancer or ductal carcinoma in situ; (3) (before neoadjuvant chemotherapy) breast tumor maximum diameter <=5cm; (4) patients with clinical cN0 and cN1 before neoadjuvant chemotherapy; (5) subcutaneous gland resection of nipple-preserving areolar complex is planned; (6) Implanted prosthesis< 600mL; (7)BMI<40 kg/m^2; (8) no clinical imaging basis for distant metastases; (9) Able and willing to sign an informed consent form. Enrollment Criteria for Group B+C: (1) Females aged 18-70 (including 18 and 70 years old); (2) Preoperative pathological confirmation of stage I and II invasive breast cancer or ductal carcinoma in situ; (3) Tumor size<=3cm; (4) a single lesion confined to the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle and nipple-areolar complex; (5) There is a clear intention to ensure breastfeeding, and radiotherapy can be standardized after surgery.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Group A+C: (1) Patients with inflammatory breast cancer; (2) tumor invasion of skin, pectoral muscle, chest wall, nipple-areolar complex; (3) Patients with late tumor stage and high risk of recurrence; (4) Breast cancer during pregnancy and lactation; (5) Scar below the nipple level of the breast and history of previous radiotherapy (such as radiotherapy after breast conserving surgery for breast cancer); (6) The patient has serious diseases before surgery, and the general condition is poor, and the patient cannot tolerate the operation; (7) Immunodeficiency; (8) HbA1c greater than 7.5%; (9) Long-term smoking history; (10) Participating in other clinical studies that may affect participation in this trial. Exclusion Criteria for Group B+C: (1) There are diffuse cancerous foci or microcalcified foci; (2) Extensive local excision could not obtain sufficient negative margins or ideal shapes; (3) The maximum diameter of the tumor before or after neoadjuvant therapy >3cm; (4) Central breast cancer and < from the nipple = 2cm; (5) The tumor is located in the lower quadrant of the "rule of thirds"; (6) bilateral breast cancer or inflammatory breast cancer; (7) There was a scar on the surface of the skin of the breast; (8) BRCA1 and BRCA2 gene mutation carriers; (9) Inability to receive general anesthesia or surgical treatment; (10) Breast cancer during pregnancy and lactation; (11) Refusal to sign the consent form; (12) Participating in other clinical studies that may affect participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oncology safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness ratio of perioperative period;Surgical safety;Aesthetic outcome;Oncology safety; | — |
Countries
China
Contacts
Public ContactDu Zhenggui
Breast Center, West China Hospital, Sichuan University, Chengdu, China
Outcome results
None listed