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NCT Number: NCT06716073

Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial

With the title of "Long-Term Outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial", this study targets breast cancer patients after neoadjuvant therapy. A total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to Endoscopic-assisted breast conserving surgery(E-BCS) or conventional breast conserving surgery (C-BCS) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. The co-primary endpoints are 5-year disease-free survival (5y-DFS) and Breast-Q score at 6 months after surgery. The secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-OS) and 5-year local-recurrence rate (5y-LRR), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. This study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.

Recruiting

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Key information

Conditions

Breast Cancer Invasive

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ranging from 18 to 75 years
  • Pathologically confirmed invasive breast cancer
  • Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen)
  • cT1-3N0-3M0
  • Unilateral breast tumor
  • Eastern Cooperative Oncology Group score 0-1
  • Left Ventricular Ejection Fraction (LVEF) ≥50%
  • Leukocytes ≥ 3.0×109/L, Absolute neutrophil count ≥ 1.5×109/L, Platelets ≥ 100×109/L, Hemoglobin ≥ 90g/L, Creatinine <1.5 × institutional ULN, Total bilirubin ≤ 2.0 × institutional ULN.

Exclusion criteria

  • Diffusely disseminated malignant calcification foci
  • Not applicable for BCS after neoadjuvant therapy
  • Pregnancy or breastfeeding
  • Additional malignancy
  • Severe cardiopulmonary, liver or kidney dysfunction or other systemic diseases (such as uncontrolled chronic heart failure, critical hypertension or diabetes with poor blood glucose control).

Treatment and study plan

Surgery

Procedure

comparison of 2 surgical procedures

Primary outcomes

  1. 5-year disease free survival

    Time frame: From surgery to the end of follow-up at 5 years

    The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up

  2. Patients' satisfaction with breast

    Time frame: From surgery to the follow-up at 6 months

    The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery

Secondary outcomes

  1. Surgeons' satisfaction with breast

    Time frame: From surgery to the follow-up at 6 months

    Surgeons evaluate the cosmetic outcome of breast based on the photos before surgery and after surgery. Four ranks: Excellent (9-10 points), Good (7-8 points), Fair (5-6 points) and Poor (0-4 points) are categorized on a basis of average total score from Ueda scale

  2. Patients satisfaction with scar

    Time frame: From surgery to the follow-up at 6 months

    Scar-Q scale including 3 tables about the surgical scar: appearance, symptom, psychosocial impact with total score of 100 will be used for evaluating patients satisfaction with scar

  3. 5-year overall survival

    Time frame: From surgery to the end of follow-up at 5 years

    The proportion of patients remaining after excluding patients who died from any cause at 5-year follow-up

  4. 5-year local-regional recurrence rate

    Time frame: From surgery to the end of follow-up at 5 years

    The proportion of patients with a lump found on breast, axilla, chest wall, skin or scars of surgery ipsilateral to the surgical side through physical examination or imaging, confirmed as the same pathological type as the primary tumor according to biopsy at 5-year follow up

  5. Postoperative complication rate

    Time frame: From surgery to the follow-up at 12 months

    The proportion of patients with postoperative complications including hemorrhage, incision dehiscence, upper limb lymphedema, infection,seroma.

  6. Surgical duration

    Time frame: Intraoperative

    The time from the beginning of surgery to the end of surgery

  7. Intraoperative blood loss

    Time frame: Intraoperative

    The blood loss during the operation

  8. Incision length

    Time frame: Intraoperative

    The length of surgical incision

Study contacts

Contact information is provided by the study sponsor or research team.

Shicheng Su

CONTACT

[email protected]

+86-13631304227

Yiwen Lu, Doctor

CONTACT

[email protected]

+86-13268121885

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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