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A National Multicenter Randomized Controlled Clinical Trial on the Efficacy and Safety of Minimally Invasive Surgery for Breast Cancer After Neoadjuvant Therapy

A National Multicenter Randomized Controlled Clinical Trial on the Efficacy and Safety of Minimally Invasive Surgery for Breast Cancer After Neoadjuvant Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113579
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Breast cancer

Interventions

Chest Muscles Front Group:Minimally invasive subpectoral breast implant placement combined with TiLoop Bra
Chest Muscles Back Group:Minimally invasive dual-plane subpectoral breast implant placement with TiLoop Bra

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Undergo preoperative treatment; 2. Female patients aged 18-70 years; 3. Clinical T1 or T2 (tumor maximum diameter =5 cm); 4. Clinical cN0 and cN1 patients; 5. No clinical or imaging evidence of distant metastasis; 6. Planned subcutaneous nipple-areola-sparing mastectomy with implant placement under endoscopy; 7. BMI <40 kg/m^2; 8. Able and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Tumor invasion of the skin, pectoral muscle, chest wall, or nipple-areolar complex (NAC); 2.Advanced tumor stage with high recurrence risk; 3.Special pathological types (e.g., inflammatory breast cancer, pregnancy- or lactation-associated breast cancer); 4.Scars below the nipple-areolar plane and a history of prior radiotherapy; 5.Preoperative comorbidity with severe diseases and poor general condition that contraindicates surgery; 6.Immunocompromise; 7.HbA1c > 7.5%; 8.Current participation in other clinical studies that may interfere with this trial.

Design outcomes

Primary

MeasureTime frame
Postoperative Aesthetic Outcomes;

Secondary

MeasureTime frame
Surgical Safety;Oncology Safety;Postoperative Complications;Perioperative Cost-Effectiveness;

Countries

China

Contacts

Public ContactXiaowei Qi

Department of Breast and Thyroid Surgery, The First Affiliated Hospital of Army Medical University

qxw9908@foxmail.com+86 135 2754 5423

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026