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Breast Cancer PatientsNCT07037537

Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

A study testing Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation in people with Breast Cancer Patients, run by Henan Cancer Hospital at 1 site 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

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer Patients
What is being tested?
Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteChina
Study dates
30 Oct 2024to Nov 2026
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18 to 70 years old;
  • In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;
  • Patients undergoing preventive mastectomy are not allowed to be included in the study;
  • Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;
  • Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive axillary lymph nodes, fine needle aspiration or hollow needle biopsy is required to confirm negative);
  • Sentinel lymph node biopsy negative;
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  • Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
  • Patients who are not suitable for breast conserving surgery or who are unwilling to undergo breast conserving surgery and plan to undergo laparoscopic assisted mastectomy with preservation of the nipple and areola, as well as immediate one-step breast reconstruction with a breast prosthesis combined with a chest muscle prosthesis and simultaneous fat transplantation; If frozen pathology or routine pathology indicates a positive posterior margin of the nipple, it is allowed to remove the nipple, but the areola must be preserved;
  • The volume of the prosthesis is less than 500cc;
  • During the observation period of the study, the affected side may consider re fat injection, but symmetrical surgery is not allowed on the healthy side;
  • ECOG score 0-1 points;
  • New adjuvant chemotherapy patients are allowed to be enrolled;
  • No smoking history or quitting smoking for at least 4 weeks;
  • The researcher determines that they are able to comply with the research protocol;
  • Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers to not affect the study protocol can be enrolled normally;
  • After obtaining sufficient information, voluntarily participate and sign an informed consent form.

Who cannot join

  • Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
  • Double breast cancer;
  • Bilateral breast reconstruction patients;
  • Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
  • Patients with incomplete immune function, poor control of diabetes and active smoking;
  • Patients with severe breast sagging;
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  • Breast cup size ≥ E;
  • Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;
  • Patients who have previously received and/or received postoperative radiotherapy for the reconstruction site or chest wall;
  • Patients who plan to undergo symmetrical surgery on the healthy breast during the visit period;
  • Patients with mental illnesses or abnormalities who are expected to be unable to independently complete the BREAST-Q scale;
  • Pregnant and lactating patients;
  • Poor compliance, unable to conduct relevant examinations and follow ups according to the trial requirements;
  • Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

Trial locations and contacts

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

xiuchun Chen contact

18603719919

cxc701024@163.com

minhao Lv contact

13838392355

zlyylvminhao2789@zzu.edu.cn

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    xiuchun Chen, 18603719919, cxc701024@163.com

    minhao Lv, 13838392355, zlyylvminhao2789@zzu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: To Evaluate the Efficacy and Safety of Laparoscopic-assisted Nipple-areola-sparing Mastectomy Plus Pectoral Anterior Prosthesis Plus Mesh Immediate One-step Breast Reconstruction Plus Concurrent Autologous Fat Grafting: a Prospective, Single-centre, Single-arm Study

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Read the detailed description

This study is a prospective, single center, single arm clinical trial. It is planned to recruit 29 patients with unilateral breast cancer of cT1-2N0M0. Patients who meet the inclusion criteria are planned to undergo laparoscopic assisted NSM+prosthesis combined with patch breast reconstruction and concurrent fat transplantation surgery.

Main endpoint of the study: incidence of severe complications after breast reconstruction surgery.

Secondary study endpoints: BREAST-Q (Breast Reconstruction Module) score, breast reconstruction success rate, incidence of all complications, physician evaluated breast cosmetic outcomes, occurrence of capsule contractures, nipple areola and breast skin sensation, and tumor safety.

Being tested
Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Keywords
Breast cancer, Endoscopic technology, Breast reconstruction surgery, Autologous fat transplantation
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantationProcedure or surgery

    Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation

Study groups in NCT07037537
Study groupRoleWhat they receive
Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantationExperimentalEndoscopic assisted NSM+prosthesis combined with patch for anterior breast reconstruction and simultaneous fat transplantation
Receives: Procedure: Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

What is being measured

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

  1. Incidence of serious complications after breast reconstruction surgery

    All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.

    Measured: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery

Secondary outcomes (7)

  1. BREAST-Q (Breast Reconstruction Module) score

    This experiment obtained subject report results from four dimensions of breast satisfaction, psychological health, physical health, and sexual health using the BREAST-Q (Breast Reconstruction Module) scoring system. BREAST-Q scoring was performed at preoperative, 1 month, 3 months, 6 months, and 12-month follow-up. The BREAST-Q score at 12 months after surgery is the main evaluation metric.

    Measured: BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up

  2. Success rate of breast reconstruction

    Calculation formula:The result of subtracting the number of implant removal cases caused by complications from the total number of breast reconstruction cases received, divided by the total number of reconstruction cases received.Definition of implant removal caused by complications: Refers to the removal of implants during the 12-month follow-up period due to surgical related reasons such as hematoma, serum swelling, skin flap necrosis, nipple areola necrosis, infection, incision dehiscence, implant exposure, capsule contraction, and prosthesis displacement.

    Measured: One year after surgery

  3. All incidence of complications

    Complications such as hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, and fat injection related complications are classified according to the Clavien Dindo scoring system, including grades I-V, and evaluated and recorded.

    Measured: On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery

  4. Breast cosmetic effects evaluated by doctors

    The cosmetic effect of breast reconstruction is evaluated by professional doctors independent of the surgeon using the ueda scoring criteria based on patient photos.

    Measured: Before surgery，on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery

  5. Occurrence of capsule contraction

    The Baker classification method (Spear\&Baker, 1995) was used for evaluation.

    Measured: one months after surgery,three months after surgery, six months after surgery, and one year after surgery

  6. Nipple, areola, and breast skin sensation

    The Semmes Weinstein single filament inspection method was used to measure tactile sensation. Semmes Weinstein Monofilament Inspection Method

    Measured: Before surgery, one week after surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery

  7. Tumor safety

    Disease free survival (DFS) and overall survival (OS). DFS defines the time from surgery to the occurrence of recurrence, metastasis, or last follow-up. OS defines the time from surgery to patient death or last follow-up.

    Measured: five years after surgery

Timeline

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

  1. First posted25 Jun 2025
  2. Study start30 Oct 2024
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037537
Sponsor's protocol ID
2024-362
Status last verified
Oct 2024
First submitted
17 Jun 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kraenzlin F, Chopra K, Kokosis G, Venturi ML, Mesbahi A, Nahabedian MY. Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants. Plast Reconstr Surg. 2021 May 1;147(5):743e-748e. doi: 10.1097/PRS.0000000000007885.

    PubMed 33890886

  • Chatterjee A, Nahabedian MY, Gabriel A, Macarios D, Parekh M, Wang F, Griffin L, Sigalove S. Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis. J Surg Oncol. 2018 May;117(6):1119-1130. doi: 10.1002/jso.24938. Epub 2018 Jan 18.

    PubMed 29346711

  • Li Y, Xu G, Yu N, Huang J, Long X. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Meta-analysis. Ann Plast Surg. 2020 Oct;85(4):437-447. doi: 10.1097/SAP.0000000000002190.

    PubMed 31913902

  • Feng Y, Liang F, Wen N, Yang H, Zhou J, Zhang S, Liu X, Qiu M, Xie Y, Du Z. An Innovative and Highly Efficient Single-Port Endoscopic Nipple-/Skin-Sparing Mastectomy and Dual-Plane Direct-to-Implant Breast Reconstruction: A Prospective Study from a Single Institution. Aesthetic Plast Surg. 2024 Mar;48(6):1133-1141. doi: 10.1007/s00266-023-03402-2. Epub 2023 May 30.

    PubMed 37253841

  • Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20.

    PubMed 31176887

  • Wang ZH, Gao GX, Liu WH, Wu SS, Xie F, Xu W, Ding GQ, Xu YQ, Zhang ZT, Qu X. Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for breast cancer. Surg Endosc. 2023 May;37(5):3842-3851. doi: 10.1007/s00464-023-09862-6. Epub 2023 Jan 25.

    PubMed 36695902

  • Li L, Su Y, Xiu B, Huang X, Chi W, Hou J, Zhang Y, Tian J, Wang J, Wu J. Comparison of prepectoral and subpectoral breast reconstruction after mastectomies: A systematic review and meta analysis. Eur J Surg Oncol. 2019 Sep;45(9):1542-1550. doi: 10.1016/j.ejso.2019.05.015. Epub 2019 May 14.

    PubMed 31256950

  • Abbate O, Rosado N, Sobti N, Vieira BL, Liao EC. Meta-analysis of prepectoral implant-based breast reconstruction: guide to patient selection and current outcomes. Breast Cancer Res Treat. 2020 Aug;182(3):543-554. doi: 10.1007/s10549-020-05722-2. Epub 2020 Jun 9.

    PubMed 32514624

  • Ostapenko E, Nixdorf L, Devyatko Y, Exner R, Wimmer K, Fitzal F. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Systemic Review and Meta-analysis. Ann Surg Oncol. 2023 Jan;30(1):126-136. doi: 10.1245/s10434-022-12567-0. Epub 2022 Oct 16.

    PubMed 36245049

  • Rancati AO, Angrigiani CH, Hammond DC, Nava MB, Gonzalez EG, Dorr JC, Gercovich GF, Rocco N, Rostagno RL. Direct to Implant Reconstruction in Nipple Sparing Mastectomy: Patient Selection by Preoperative Digital Mammogram. Plast Reconstr Surg Glob Open. 2017 Jun 20;5(6):e1369. doi: 10.1097/GOX.0000000000001369. eCollection 2017 Jun.

    PubMed 28740781

  • Sigalove S. Prepectoral breast reconstruction and radiotherapy-a closer look. Gland Surg. 2019 Feb;8(1):67-74. doi: 10.21037/gs.2019.01.01.

    PubMed 30842930

  • Sorrentino L, Regolo L, Scoccia E, Petrolo G, Bossi D, Albasini S, Caruso A, Vanna R, Morasso C, Mazzucchelli S, Truffi M, Corsi F. Autologous fat transfer after breast cancer surgery: An exact-matching study on the long-term oncological safety. Eur J Surg Oncol. 2019 Oct;45(10):1827-1834. doi: 10.1016/j.ejso.2019.05.013. Epub 2019 May 21.

    PubMed 31133371

  • Gronovich Y, Winder G, Maisel-Lotan A, Lysy I, Sela E, Spiegel G, Carmon M, Hadar T, Elami A, Eizenman N, Binenboym R. Hybrid Prepectoral Direct-to-Implant and Autologous Fat Graft Simultaneously in Immediate Breast Reconstruction: A Single Surgeon's Experience with 25 Breasts in 15 Consecutive Cases. Plast Reconstr Surg. 2022 Mar 1;149(3):386e-391e. doi: 10.1097/PRS.0000000000008879.

    PubMed 35196670

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation in people with Breast Cancer Patients, run by Henan Cancer Hospital at 1 site 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 16 inclusion and 14 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 xiuchun Chen (18603719919, cxc701024@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious complications after breast reconstruction surgery (time frame: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery). 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 NCT07037537, which also lists 13 linked publications.

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 25 Jun 2025.

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