Breast Cancer
Conditions
Interventions
Experimental Group:Tissue filler material
Control Group:none
Sponsors
Cancer Hospital,Chinese Academy of Medical Sciences;The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically/cytologically diagnosed with unilateral breast cancer; 2. Scheduled for surgical treatment and deemed eligible for breast-conserving surgery (BCS) by the investigator prior to surgery; 3. Female, aged 18 years = age = 70 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Adequate bone marrow and organ function: Neutrophil count = 1.5 × 10^9/L; Platelet count = 75 × 10^9/L; Hemoglobin = 9.0 g/dL; Total bilirubin = 1.5 × ULN; Prothrombin time and activated partial thromboplastin time = 1.5 × ULN; Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2.5 × ULN; Creatinine = 1.5 × ULN; 6. Subjects must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies within the past 5 years (excluding cured non-melanoma skin cancer, cervical carcinoma in situ, or thyroid malignancies treated with radical therapy with no evidence of recurrence within 3 years); 2. Patients with a Zeng-Jing method breast aesthetic score <10 during screening that may affect efficacy assessment; 3. Patients with prior radiotherapy to the ipsilateral breast or chest wall; 4. Patients with prior breast surgery judged by the investigator to have compromised breast appearance, potentially confounding clinical assessment in this study; 5. Participation in other drug/device clinical trials involving investigational products within 2 weeks prior to screening; 6. Patients who underwent major organ surgery (excluding needle biopsy) within 4 weeks prior to screening; 7. Patients who received systemic glucocorticoid or immunosuppressive therapy within 2 weeks prior to screening; EXCEPT: use of topical skin, ocular, intra-articular, intranasal, or inhaled glucocorticoids; short-term glucocorticoid prophylaxis (e.g., for contrast allergy prevention); 8. Patients with confirmed brain metastases, meningeal metastases, or metastases to other organs; 9. Patients with concomitant diabetes, uncontrolled active infection, active bleeding/confirmed bleeding tendency, or systemic sclerosis; 10. Average daily smoking exceeding 5 cigarettes within 4 weeks prior to screening; 11. Known allergy to porcine-derived materials or current allergic disease; 12. Religious beliefs with doctrinal prohibitions against using the study material; 13. Severe psychiatric disorders assessed by the investigator as likely to interfere with trial conduct or clinical evaluation; 14. Pregnant or lactating women; 15. Other conditions where participation may increase the subject's risk or is deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast Aesthetic Effect Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast-Q Score; | — |
Countries
China
Contacts
Public ContactWang Jing;FuPeifen
Cancer Hospital, Chinese Academy of Medical Sciences;The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed