Breast Cancer
Conditions
Interventions
Test Group:Tissue filling materials
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Histological/cytological diagnosis of unilateral breast cancer; (2) Surgical treatment is planned and the investigators judge that it meets the indications of breast conserving surgery (BCS) before surgery; (3) 18 years old = age =65 years old, female; (4) The physical status score of ECOG was 0-1; (5) Adequate bone marrow and organ function: neutrophil count =1.5×10^9/L; Platelet count =75×10^9/L; Hemoglobin =9.0g/dL; Total bilirubin =1.5×ULN; Prothrombin time and partial thrombin time =1.5×ULN; ALT and/or aspartate aminotransferase (AST) =2.5×ULN; Serum creatinine =1.5×ULN; (6) Patients must give informed consent to this study before the experiment and sign a written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Have a history of other malignancies within 5 years prior to screening (participants may participate in this study if they have skin basal cell carcinoma or cervical carcinoma in situ and have been cured) or have a current co-existing malignancy; (2) Patients who have previously received breast or chest wall radiotherapy on the same breast; (3) Patients who have had the primary breast cancer lesion removed before surgery; (4) Had a history of breast surgery and was judged by the investigator to have affected the appearance of the breast and thus confused the clinical evaluators of this study; (5) Participated in other drug/device clinical studies and used the experimental drug/device within 4 weeks before using the investigational device; (6) had undergone major organ surgery (excluding needle biopsy) within 4 weeks prior to the use of the study instrument; (7) received systemic glucocorticoid or other immunosuppressive therapy within 2 weeks prior to use of the study device; Except in the following cases: treatment with local skin, eye, articular, intranasal and inhaled corticosteroids; Short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media); (8) The adverse reactions of previous anti-tumor therapy have not returned to the Common terminology evaluation criteria for Adverse events (CTCAE v5.0) grade =1 (alopecia or peripheral neuropathy =2); (9) Patients with definite brain metastases, meningeal metastases and other organ metastases; (10) Patients with diabetes; (11) Average daily smoking in the 4 weeks prior to surgery exceeded 5 (12) Patients with active infection within 1 week before surgery and currently in need of systemic anti-infection therapy; (13) Patients with a history of active bleeding within 2 weeks before surgery or who have a definite bleeding tendency according to the investigator; (14) People who are known to be allergic to porcine source materials, allergic constitution or are currently suffering from allergic diseases; (15) Those who have religious beliefs and religious teachings have taboos on the use of test material ingredients; (16) A person with a serious mental disorder that is assessed by the investigator to affect the conduct or clinical evaluation of this trial; (17) Pregnant or lactating women; (18) The patient has other conditions and the investigator has assessed that participation in the study may increase the subject's risk or the investigator has determined that participation in the study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aesthetic effect evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast-Q score;Evaluation of operating satisfaction of instruments; | — |
Countries
China
Contacts
Public ContactFuPeifen
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed