Breast Cancer Early Stage Breast Cancer (Stage 1-3)HUAXI-h-01NCT06995118
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
A study testing HUAXI hole 1 in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Du Zhenggui at 20 sites in China.
Trial summary
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- HUAXI hole 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 20 sitesChina
- Study dates
- 17 Jun 2025to 31 Dec 2031
- 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
- Female patients aged 18-70 years (inclusive18 and 70 years);
- Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;
- Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;
- For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;
- Patients volunteered to provide informed consent.
Who cannot join
- History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);
- Breast cancer diagnosed during pregnancy or lactation;
- Subnipple-plane scarring with radiotherapy;
- Metastatic breast cancer (M1);
- Severe comorbidities precluding general anesthesia or surgery;
- BMI ≥40 kg/m²;
Show all 10Show fewer
- HbA1c >7.5%;
- Immunodeficiency;
- Active smoking with ≥20 cigarettes per day
- Patients with concurrent participation in conflicting clinical trials.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
Anyang City Tumor Hospital
Anyang, Henan, 455000
Ya Wei, +86 13939993106, wei13939993106@163.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Dong Song, Dr., +86 13943189777, songdong@jlu.edu.cn
- Not yet recruiting
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410000
Jinhui Hu, +86 13637412178, hujinhui173@163.com
- Not yet recruiting
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan, 610011
Donglin Zhang, Dr., +86 13684050025, zoomail@126.com
- Not yet recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 610041
Junyan Li, Dr., +86 18113583236, lijunyan4990@126.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Hao Wang, +86 13518204307, Unique214@163.com
- Recruiting
West China hospital of Sichuan University
Chengdu, Sichuan, 610041
Zhenggui Du, Dr., +86 13880768222, docduzg@163.com
Hui Dai, +86 18075202377, daih108@163.com
- Not yet recruiting
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu, Sichuan, 610041
Bin Ma, Dr., +86 13999878091, 55898790@qq.com
- Not yet recruiting
West China Tianfu Hospital
Chengdu, Sichuan, 610041
Jing Wang, Dr., +86 18980601457, wangjinghxyy@163.com
- Not yet recruiting
The People's Hospital of Dazu, Chongqing
Chongqing, 400000
Qiang Liu, +86 15922846047, 1795135859@gq.com
- Not yet recruiting
Deyang People's Hospital
Deyang, Sichuan, 618000
Xuemei Jiang, +86 13981093933, 360410334@qq.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Fangmeng Fu, +86 13365917923, ffm@fjmu.edu.cn
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000
Di Huang, +86 13631455489, penguinzone@163.com
- Not yet recruiting
The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Junwen Bai, +86 13654811311, baijunwen2001@163.com
- Not yet recruiting
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000
Yong Liu, +86 13981183899, 709405660@qq.com
- Not yet recruiting
Nanchang People's Hospital
Nanchang, Jiangxi, 330000
Yali Cao, +86 13330108883, namexll@163.com
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
You Meng, Dr., +86 13912774015, 13912774015@163.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Haibo Yang, Dr., +86 13835191210,, haiboyangtg@163.com
- Not yet recruiting
Taiyuan Central Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
Bin Li, Dr., +86 13546111615, 12356086@gq.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Youyi Xiong, Dr., +86 15736792587, xiongyouyi1987@126.com
About this study
Official title: The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Read the detailed description
Conventional open nipple-sparing mastectomy (NSM) often results in significant surgical scarring, which is detrimental to the aesthetic outcome of the breast and the patient's psychosocial well-being. Meanwhile, endoscopic NSM has been reported to achieve favorable aesthetic outcomes and surgical safety. However, traditional endoscopic NSM has high technical difficulty and low surgical efficiency.
Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.
To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.
Therefore, this national multicenter, open-label, randomized controlled trial will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
- Being tested
- HUAXI hole 1
- Keywords
- Breast Cancer, Endoscopic surgery, Nipple-sparing mastectomy, Minimal invasive surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUAXI hole 1Procedure or surgery
A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| HH-01 group | Experimental | Use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction Receives: Procedure: HUAXI hole 1 |
| Control group | No intervention | Don't use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions.
Measured: Immediate postoperative
Secondary outcomes (10)
Complications
Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission
Measured: Immediate postoperative, within 3-month postoperative, and within 1-year postoperative
Aesthetic outcome evaluation--BREAST-Q scores
The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores
Measured: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
Aesthetic outcome evaluation--Harris score
The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).
Measured: 3-month postoperative and 2-year postoperative
Aesthetic outcome evaluation--Ueda score
Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented
Measured: 3-month postoperative and 2-year postoperative
Quality of Life--BREAST-Q scores
The Psychosocial Well-Being, Sexual Well-Being, and Physical Well-Being of the Chest modules of BREAST-Q questionnaire are used to evaluate quality of life (QoL) outcomes. Transformed scores range from 0 to 100, with higher values indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be recorded, along with pre- to postoperative differences in transformed scores
Measured: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
Surgical margin involvement
Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination
Measured: 2-3 weeks postoperative after paraffin-embedded pathological report available
Resection mastectomy weight
Mean mastectomy weight (g)
Measured: Immediate postoperative
Local Recurrence-Free Survival(LRFS)
The time interval from initiation of treatment to the first recurrence at the primary tumor site.If local recurrence appears, record the time and location of recurrence
Measured: 2-year postoperative and 5-year postoperative
Disease-Free Survival(DFS)
The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location.
Measured: 2-year postoperative and 5-year postoperative
Overall Survival(OS)
The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason.
Measured: 2-year postoperative and 5-year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start17 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 337 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Zhenggui
- Sponsor type
- University, hospital or other
- Collaborators
- West China Tianfu Hospital, West China Fourth Hospital, Fourth People's Hospital of Sichuan Province, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Shanxi Bethune Hospital, Chengdu Fifth People's Hospital, Suzhou Municipal Hospital, Taiyuan Central Hospital of Shanxi Medical University, The People's Hospital of DAZU ，Chongqing, Anyang City Tumor Hospital, Mianyang Hospital of Traditional Chinese Medicine, Sichuan Cancer Hospital and Research Institute, Deyang People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Guangzhou First People's Hospital, Fujian Medical University Union Hospital, Nanchang Third Hospital
- Responsible party
- Sponsor-investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995118
- Sponsor's protocol ID
- 2024(2591)
- Acronym
- HUAXI-h-01
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
Publications
Ho WS, Ying SY, Chan AC. Endoscopic-assisted subcutaneous mastectomy and axillary dissection with immediate mammary prosthesis reconstruction for early breast cancer. Surg Endosc. 2002 Feb;16(2):302-6. doi: 10.1007/s004640000203. Epub 2001 Nov 16.
PubMed 11967683Yang H, Liang F, Xie Y, Qiu M, Du Z. Single axillary incision reverse-order endoscopic nipple/skin-sparing mastectomy followed by subpectoral implant-based breast reconstruction: Technique, clinical outcomes, and aesthetic results from 88 preliminary procedures. Surgery. 2023 Sep;174(3):464-472. doi: 10.1016/j.surg.2023.05.037. Epub 2023 Jul 7.
PubMed 37422354Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
PubMed 29484564Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.
PubMed 38348883Qiu M, Liang F, Xie Y, Yang H, Zhang Q, Zhong J, Dai H, Du Z. Clinical Outcomes of Transaxillary Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy and Direct-to-Implant Prepectoral Breast Reconstruction: A Prospective Study of Initial 68 Procedures. Ann Surg Oncol. 2024 Apr;31(4):2777-2785. doi: 10.1245/s10434-023-14687-7. Epub 2024 Feb 9.
PubMed 38334846Feng Y, Xie Y, Liang F, Zhou J, Yang H, Qiu M, Zhang Q, Liu Y, Liang P, Du Z. Twenty-four-hour discharge of patients after endoscopic nipple-sparing mastectomy and direct-to-implant breast reconstruction: safety and aesthetic outcomes from a prospective cohort study. Br J Surg. 2024 Jan 3;111(1):znad356. doi: 10.1093/bjs/znad356. No abstract available.
PubMed 37991082Lai HW, Chen DR, Liu LC, Chen ST, Kuo YL, Lin SL, Wu YC, Huang TC, Hung CS, Lin YJ, Tseng HS, Mok CW, Cheng FT. Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P). Ann Surg. 2024 Jan 1;279(1):138-146. doi: 10.1097/SLA.0000000000005924. Epub 2023 May 25.
PubMed 37226826Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977.
PubMed 39141399
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)
- ClinicalTrials.gov ID
- NCT06995118
- Acronym / sponsor ID
- HUAXI-h-01 / 2024(2591)
- Keywords
- Breast Cancer, Endoscopic surgery, Nipple-sparing mastectomy, Minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 337 participants (estimated)
- Lead sponsor
- Du ZhengguiUniversity, hospital or other
- Collaborators
- West China Tianfu Hospital, West China Fourth Hospital, Fourth People's Hospital of Sichuan Province, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Shanxi Bethune Hospital, Chengdu Fifth People's Hospital, Suzhou Municipal Hospital, Taiyuan Central Hospital of Shanxi Medical University, The People's Hospital of DAZU ，Chongqing, Anyang City Tumor Hospital, Mianyang Hospital of Traditional Chinese Medicine, Sichuan Cancer Hospital and Research Institute, Deyang People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Guangzhou First People's Hospital, Fujian Medical University Union Hospital, Nanchang Third Hospital
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Detailed description
Conventional open nipple-sparing mastectomy (NSM) often results in significant surgical scarring, which is detrimental to the aesthetic outcome of the breast and the patient's psychosocial well-being. Meanwhile, endoscopic NSM has been reported to achieve favorable aesthetic outcomes and surgical safety. However, traditional endoscopic NSM has high technical difficulty and low surgical efficiency.
Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.
To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.
Therefore, this national multicenter, open-label, randomized controlled trial will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-01 group | Experimental | Procedure: HUAXI hole 1Use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction |
| Control group | No intervention | –Don't use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-70 years (inclusive18 and 70 years);
- Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;
- Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;
- For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;
- Patients volunteered to provide informed consent.
Key exclusion criteria (10 listed)
- History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);
- Breast cancer diagnosed during pregnancy or lactation;
- Subnipple-plane scarring with radiotherapy;
- Metastatic breast cancer (M1);
- Severe comorbidities precluding general anesthesia or surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUAXI hole 1A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction. | Procedure or surgery | HH-01 group |
Primary outcome
Operative time
Time frame: Immediate postoperative
Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions.
10 secondary outcomes
Complications
Time frame: Immediate postoperative, within 3-month postoperative, and within 1-year postoperative
Aesthetic outcome evaluation--BREAST-Q scores
Time frame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
Aesthetic outcome evaluation--Harris score
Time frame: 3-month postoperative and 2-year postoperative
Aesthetic outcome evaluation--Ueda score
Time frame: 3-month postoperative and 2-year postoperative
Quality of Life--BREAST-Q scores
Time frame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
Surgical margin involvement
Time frame: 2-3 weeks postoperative after paraffin-embedded pathological report available
Resection mastectomy weight
Time frame: Immediate postoperative
Local Recurrence-Free Survival(LRFS)
Time frame: 2-year postoperative and 5-year postoperative
Disease-Free Survival(DFS)
Time frame: 2-year postoperative and 5-year postoperative
Overall Survival(OS)
Time frame: 2-year postoperative and 5-year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 11967683Ho WS, Ying SY, Chan AC. Endoscopic-assisted subcutaneous mastectomy and axillary dissection with immediate mammary prosthesis reconstruction for early breast cancer. Surg Endosc. 2002 Feb;16(2):302-6. doi: 10.1007/s004640000203. Epub 2001 Nov 16.
- Background: PubMed 37422354Yang H, Liang F, Xie Y, Qiu M, Du Z. Single axillary incision reverse-order endoscopic nipple/skin-sparing mastectomy followed by subpectoral implant-based breast reconstruction: Technique, clinical outcomes, and aesthetic results from 88 preliminary procedures. Surgery. 2023 Sep;174(3):464-472. doi: 10.1016/j.surg.2023.05.037. Epub 2023 Jul 7.
- Background: PubMed 29484564Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
- Background: PubMed 38348883Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.
- Background: PubMed 38334846Qiu M, Liang F, Xie Y, Yang H, Zhang Q, Zhong J, Dai H, Du Z. Clinical Outcomes of Transaxillary Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy and Direct-to-Implant Prepectoral Breast Reconstruction: A Prospective Study of Initial 68 Procedures. Ann Surg Oncol. 2024 Apr;31(4):2777-2785. doi: 10.1245/s10434-023-14687-7. Epub 2024 Feb 9.
- Background: PubMed 37991082Feng Y, Xie Y, Liang F, Zhou J, Yang H, Qiu M, Zhang Q, Liu Y, Liang P, Du Z. Twenty-four-hour discharge of patients after endoscopic nipple-sparing mastectomy and direct-to-implant breast reconstruction: safety and aesthetic outcomes from a prospective cohort study. Br J Surg. 2024 Jan 3;111(1):znad356. doi: 10.1093/bjs/znad356. No abstract available.
- Background: PubMed 37226826Lai HW, Chen DR, Liu LC, Chen ST, Kuo YL, Lin SL, Wu YC, Huang TC, Hung CS, Lin YJ, Tseng HS, Mok CW, Cheng FT. Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P). Ann Surg. 2024 Jan 1;279(1):138-146. doi: 10.1097/SLA.0000000000005924. Epub 2023 May 25.
- Background: PubMed 39141399Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HUAXI hole 1 in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Du Zhenggui at 20 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 5 inclusion and 10 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 Zhenggui Du, MD (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Immediate postoperative). 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 NCT06995118, which also lists 8 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 2 Jul 2025.