Skip to content

A multicenter randomized controlled clinical trial comparing endoscopic/robotic minimally invasive surgery with open breast-conserving surgery after neoadjuvant therapy

A multicenter randomized controlled clinical trial comparing laparoscopic/robotic minimally invasive surgery with open breast-conserving surgery after neoadjuvant therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118627
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-14
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Experimental Group:Endoscopic breast-conserving surgery or robotic breast-conserving surgery
Control group:Open breast-conserving surgery

Sponsors

The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years and = 90 g/L, absolute neutrophil count >= 1.5×10?/L, platelets >= 100×10?/L, white blood cells >= 2.5×10?/L; total bilirubin = 50 mL/min (Cockcroft–Gault formula); coagulation function: PT, APTT, INR = 55%, 12-lead ECG shows QT interval < 470 ms in females; 8. Voluntarily join this study, sign the informed consent form, have good compliance and be willing to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1.Those who have undergone any type of breast plastic surgery in the past (including breast implant placement, breast reduction/elevation, fat transplantation for breast augmentation, nipple and areola plastic surgery, etc.); 2. The pathological type is a special type of breast cancer (such as inflammatory breast cancer, breast Paget's disease); 3. Have received anti-tumor treatment or radiotherapy for any malignant tumor within the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma; 4. Disease progression (such as tumor enlargement, new distant metastases) occurs after neoadjuvant therapy or partial response (PR) or higher efficacy is not achieved; 5. There is breast cancer metastasis; 6. Bilateral breast cancer; 7. There are uncontrollable comorbidities (such as severe heart failure, acute exacerbation of chronic obstructive pulmonary disease, active infection, etc.), making it impossible to tolerate surgery; 8. Simultaneously participate in clinical trials of other anti-tumor therapies (including endocrine therapy or immunotherapy, etc.); 9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 10. There is a known history of abuse or drug use of psychotropic substances; 11. In the lactation or pregnancy period; 12. Any other circumstances in which the researcher deems the patient unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Patient satisfaction score;

Secondary

MeasureTime frame
Surgery-related indicators;Immune function indicators;Disease-free survival period;Overall survival;Survival period without local recurrence;

Countries

China

Contacts

Public ContactZhang Yi

The First Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army

1932837358@qq.com+86 139 8370 1489

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026