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Breast Cancer InvasiveNCT06716073

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

A study testing Surgery in people with Breast Cancer Invasive, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer Invasive
What is being tested?
Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
804 participants
Where
2 sitesChina
Study dates
1 Aug 2024to 1 Jan 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shicheng Su contact

+86-13631304227

sushch@mail.sysu.edu.cn

Yiwen Lu, Doctor contact

+86-13268121885

luyw8@mail.sysu.edu.cn

China2 sites, 2 recruiting

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

    Guangzhou, Guangdong, 510120

    Shicheng Su, +86-13631304227, sushch@mail.sysu.edu.cn

    Recruiting

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital

    Shantou, Guangdong

    Yandan Yao, +86-13826292688, yaoyand@mail.sysu.edu.cn

    Not yet recruiting

Other trials in China

About this study

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 804 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.

Being tested
Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    comparison of 2 surgical procedures

Study groups in NCT06716073
Study groupRoleWhat they receive
Endoscopic breast-conserving surgery (E-BCS) groupExperimentalNot described
Receives: Procedure: Surgery
Conventional breast-conserving surgery (C-BCS) groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year disease free survival

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

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

  2. Patients' satisfaction with breast

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

    Measured: From surgery to the follow-up at 6 months

Secondary outcomes (8)

  1. Surgeons' satisfaction with breast

    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

    Measured: From surgery to the follow-up at 6 months

  2. Patients satisfaction with scar

    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

    Measured: From surgery to the follow-up at 6 months

  3. 5-year overall survival

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

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

  4. 5-year local-regional recurrence rate

    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

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

  5. Postoperative complication rate

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

    Measured: From surgery to the follow-up at 12 months

  6. Surgical duration

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

    Measured: Intraoperative

  7. Intraoperative blood loss

    The blood loss during the operation

    Measured: Intraoperative

  8. Incision length

    The length of surgical incision

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start1 Aug 2024
  3. Primary completion1 Jan 2033 (estimated)
  4. Study completion1 Jan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
804 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716073
Sponsor's protocol ID
SYSKY-2024-648-01
Status last verified
May 2026
First submitted
29 Nov 2024
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Surgery in people with Breast Cancer Invasive, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shicheng Su (+86-13631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year disease free survival (time frame: From surgery to the end of follow-up at 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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