Breast CancerDELTINCT07757074
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
An observational study of Breast Cancer, run by Du Zhenggui at 1 site in China.
Trial summary
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Surgery options
- Type of treatment
- Surgery or procedure
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Sep 2028
- Phase
- Observational
- 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
Study population: Collecting the data of breast cancer patients who visited our hospital and the cooperative units from 2026 to 2027.
Who may be able to join
- Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer;
- Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy;
- Patients who are able and willing to sign the informed consent form.
Who cannot join
- Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis;
- Patients who had the pectoralis major muscle resected during the initial mastectomy;
- History of thoracic or back surgery with suspected damage to the thoracodorsal vessels;
- Poor general condition and inability to tolerate surgery;
- Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking;
- Participation in other clinical studies that may interfere with this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China hospital of Sichuan University
Chengdu, Sichuan, 610000
Zhenggui Du, +86 13880768222, docduzg@163.com
About this study
Official title: A National Multicenter, Prospective Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Latissimus Dorsi ± Implant Breast Reconstruction Following Mastectomy
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively. Factors like physician skills, patient attitudes, economics, and tumor-related issues have led to a breast-conserving rate of about 19.5% nationwide, and less than 10% in non-first-tier cities. The immediate breast reconstruction rate after mastectomy is around 10.7%, with over 70% of patients losing their breasts during initial surgery. These patients often face long-term suboptimal psychological health post-surgery. As treatment outcomes improve, more patients are seeking delayed breast reconstruction.
Breast reconstruction after simple mastectomy faces challenges due to insufficient skin and tissue volume. Traditional methods include: (1) A two - stage procedure with a tissue expander in the first stage and prosthesis replacement in the second stage. This approach increases costs, requires two surgeries and anesthetics, and carries higher risks of incision dehiscence, prosthesis exposure, infection, and surgical failure. (2) Autologous reconstruction using the latissimus dorsi muscle flap, which involves simultaneous surgery on donor and recipient sites. This method results in significant trauma, longer operating times, higher complication risks, compromised sensation and function, large scars, and potential shoulder - related issues. Due to limited tissue volume, a prosthesis is often needed. While autologous reconstruction offers better breast satisfaction and social psychological health, its complexity and costs limit patient acceptance.
To tackle these challenges, our team has developed a minimally invasive, two - stage endoscopic breast reconstruction technique via an axillary approach with an inflation method. This approach reduces surgical time, trauma, and costs, minimizes complications, and enables faster recovery. The tension - free axillary incision eliminates the risk of dehiscence. Skin expansion through the prosthesis cavity results in a more natural - looking and softer breast. No studies have compared this technique with latissimus dorsi ± prosthesis reconstruction after simple mastectomy. We propose a prospective cohort study to evaluate its safety and feasibility, aiming to offer a more cost - effective, simple, and efficient reconstruction option to improve patients' quality of life.
Read the detailed description
This study is a multicenter, open, prospective cohort study. Inclusion criteria: (1) Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer; (2) Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy; (3) Patients who are able and willing to sign the informed consent form.
Exclusion criteria: (1) Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis; (2) Patients who had the pectoralis major muscle resected during the initial mastectomy; (3) History of thoracic or back surgery with suspected damage to the thoracodorsal vessels; (4) Poor general condition and inability to tolerate surgery; (5) Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking; (6) Participation in other clinical studies that may interfere with this trial.
Prior to group allocation, investigators at each research center will first stratify the subjects by radiotherapy. The subjects will be divided into two groups based on whether they have received radiotherapy, with the sample size ratio of the radiotherapy group to the non-radiotherapy group being 1:2. Subsequently, the subjects will be assigned to the two-stage endoscopic immediate prosthesis breast reconstruction group (with a proportion of "3") and the latissimus dorsi±prosthesis breast reconstruction group (with a proportion of "1"). The target sample size is 268 participants, comprising 89 in the radiotherapy group (67 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 22 in the latissimus dorsi±prosthesis breast reconstruction group) and 179 in the non-radiotherapy group (134 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 45 in the latissimus dorsi±prosthesis breast reconstruction group).
Collecting data includes encompassing demographics (e.g., age, BMI, breast ptosis), medical history (e.g., comorbidities, prior surgeries, family cancer history), oncological profiles (e.g., tumor type, size, location, stage, immunohistochemistry, nodal status, neoadjuvant/adjuvant therapies), and surgical details (e.g., procedure type, operative time, intraoperative blood loss, margin status, gland resection weight, implant size, drainage placement) from preoperatively to postoperatively. Postoperative follow-ups at 1 month, 6 months, 1 year will document complications, cosmesis (BREAST-Q, SCAR-Q, QLQ-BR45, Harris and Ueda assessments). Complications are recorded per patient, with events classified as major, minor, or any using the Clavien-Dindo grading system (Grades I-II: minor; III-IV: major). BREAST-Q/SCAR-Q/QLQ-BR45 questionnaires will be completed preoperatively and at 6 months/12 months postoperatively, alongside Harris and Ueda assessments and standardized breast photography (anteroposterior, lateral, oblique views).
An interim analysis will occur 1 year after study initiation and 1 month post-enrollment completion. Final analysis follows 1-year postoperative follow-up for all participants. Categorical variables will be analyzed using chi-square or Fisher's exact tests; continuous variables via t-tests, ANOVA, or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. Survival outcomes will employ Kaplan-Meier curves with log-rank testing.
- Conditions
- Breast Cancer
- Being tested
- Surgery options
- Keywords
- Breast Cancer, delayed Endoscopic DTI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery optionsProcedure or surgery
The different surgery options for patients Post-Mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 | Delayed Endoscopic DTI Breast Reconstruction Receives: Procedure: Surgery options | |
| Control group 2 | Latissimus dorsi ± impalnt Breast Reconstruction Receives: Procedure: Surgery options |
What is being measured
The primary outcome is the main question the study is designed to answer.
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), 1-year 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: 1 year postoperative
Surgical time
data evaluation
Measured: Intraoperative
surgical-related costs
perioperative data evaluation
Measured: perioperative
the rate of contralateral breast adjustment surgery
perioperative data evaluation
Measured: perioperative
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: 1 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: 1-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: 1-year postoperative
Quality of Life--EORTC Quality of Life scores
EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms
Measured: 1-year postoperative
Scar assessment--SCAR-Q scales
The SCAR-Q questionnaire is utilized to assess patient-reported scar outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw and standardized transformed scores will be documented, along with pre- to postoperative differences.
Measured: 1-year postoperative
Aesthetic outcome evaluation--aesthetic complications
Capsular contracture, Implant visibility, Rippling, Implant displacement, Animation deformity, Pectoralis major pain.
Measured: 1-year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Zhenggui
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, West China Second Hospital, Sichuan University, Fourth People's Hospital of Sichuan Province, The Second People's Hospital of Chengdu, Suzhou Municipal Hospital
- Responsible party
- Sponsor-investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757074
- Sponsor's protocol ID
- 2025（1441）
- Acronym
- DELTI
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 11 Aug 2026
- 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
Santosa KB, Qi J, Kim HM, Hamill JB, Wilkins EG, Pusic AL. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):891-899. doi: 10.1001/jamasurg.2018.1677.
PubMed 29926096Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.
PubMed 29926077Jagsi R, Jiang J, Momoh AO, Alderman A, Giordano SH, Buchholz TA, Pierce LJ, Kronowitz SJ, Smith BD. Complications After Mastectomy and Immediate Breast Reconstruction for Breast Cancer: A Claims-Based Analysis. Ann Surg. 2016 Feb;263(2):219-27. doi: 10.1097/SLA.0000000000001177.
PubMed 25876011Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.
PubMed 37380747Min K, Jeon DN, Han HH, Kim EK, Eom JS. Inframammary Fold Approach for Second-stage Operation in Expander-Implant Breast Reconstruction. Ann Plast Surg. 2021 Nov 1;87(5):501-505. doi: 10.1097/SAP.0000000000002629.
PubMed 33346535Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.
PubMed 37410610Yang B, Ren G, Song E, Pan D, Zhang J, Wang Y, Liao N, Tang J, Wang X, Cui S, Jin F, Geng C, Sun Q, Li H, Fan Z, Cao X, Wang H, Wang S, Shao Z, Wu J. Current Status and Factors Influencing Surgical Options for Breast Cancer in China: A Nationwide Cross-Sectional Survey of 110 Hospitals. Oncologist. 2020 Oct;25(10):e1473-e1480. doi: 10.1634/theoncologist.2020-0001. Epub 2020 May 13.
PubMed 32333626Zhao R, Jin M, Gao J, Zhang L, Tao L, Bao X. A Cross-Sectional Study of Breast Cancer Surgery and the Cost Based on Data From 77 Chinese 3A Hospitals in 2015. Front Oncol. 2022 Apr 26;12:857359. doi: 10.3389/fonc.2022.857359. eCollection 2022.
PubMed 35558511Sun K, Zhang B, Lei S, Zheng R, Liang X, Li L, Feng X, Zhang S, Zeng H, Yao Y, Ma P, Wang S, Chen R, Han B, Wei W, He J. Incidence, mortality, and disability-adjusted life years of female breast cancer in China, 2022. Chin Med J (Engl). 2024 Oct 20;137(20):2429-2436. doi: 10.1097/CM9.0000000000003278. Epub 2024 Sep 5.
PubMed 39238088Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter, Prospective Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Latissimus Dorsi ± Implant Breast Reconstruction Following Mastectomy
- ClinicalTrials.gov ID
- NCT07757074
- Acronym / sponsor ID
- DELTI / 2025（1441）
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, delayed Endoscopic DTI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Du ZhengguiUniversity, hospital or other
- Collaborators
- West China Hospital, West China Second Hospital, Sichuan University, Fourth People's Hospital of Sichuan Province, The Second People's Hospital of Chengdu, Suzhou Municipal Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 Aug 2026 (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.
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively. Factors like physician skills, patient attitudes, economics, and tumor-related issues have led to a breast-conserving rate of about 19.5% nationwide, and less than 10% in non-first-tier cities. The immediate breast reconstruction rate after mastectomy is around 10.7%, with over 70% of patients losing their breasts during initial surgery. These patients often face long-term suboptimal psychological health post-surgery. As treatment outcomes improve, more patients are seeking delayed breast reconstruction.
Breast reconstruction after simple mastectomy faces challenges due to insufficient skin and tissue volume. Traditional methods include: (1) A two - stage procedure with a tissue expander in the first stage and prosthesis replacement in the second stage. This approach increases costs, requires two surgeries and anesthetics, and carries higher risks of incision dehiscence, prosthesis exposure, infection, and surgical failure. (2) Autologous reconstruction using the latissimus dorsi muscle flap, which involves simultaneous surgery on donor and recipient sites. This method results in significant trauma, longer operating times, higher complication risks, compromised sensation and function, large scars, and potential shoulder - related issues. Due to limited tissue volume, a prosthesis is often needed. While autologous reconstruction offers better breast satisfaction and social psychological health, its complexity and costs limit patient acceptance.
To tackle these challenges, our team has developed a minimally invasive, two - stage endoscopic breast reconstruction technique via an axillary approach with an inflation method. This approach reduces surgical time, trauma, and costs, minimizes complications, and enables faster recovery. The tension - free axillary incision eliminates the risk of dehiscence. Skin expansion through the prosthesis cavity results in a more natural - looking and softer breast. No studies have compared this technique with latissimus dorsi ± prosthesis reconstruction after simple mastectomy. We propose a prospective cohort study to evaluate its safety and feasibility, aiming to offer a more cost - effective, simple, and efficient reconstruction option to improve patients' quality of life.
Detailed description
This study is a multicenter, open, prospective cohort study. Inclusion criteria: (1) Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer; (2) Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy; (3) Patients who are able and willing to sign the informed consent form.
Exclusion criteria: (1) Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis; (2) Patients who had the pectoralis major muscle resected during the initial mastectomy; (3) History of thoracic or back surgery with suspected damage to the thoracodorsal vessels; (4) Poor general condition and inability to tolerate surgery; (5) Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking; (6) Participation in other clinical studies that may interfere with this trial.
Prior to group allocation, investigators at each research center will first stratify the subjects by radiotherapy. The subjects will be divided into two groups based on whether they have received radiotherapy, with the sample size ratio of the radiotherapy group to the non-radiotherapy group being 1:2. Subsequently, the subjects will be assigned to the two-stage endoscopic immediate prosthesis breast reconstruction group (with a proportion of "3") and the latissimus dorsi±prosthesis breast reconstruction group (with a proportion of "1"). The target sample size is 268 participants, comprising 89 in the radiotherapy group (67 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 22 in the latissimus dorsi±prosthesis breast reconstruction group) and 179 in the non-radiotherapy group (134 in the two-stage endoscopic immediate prosthesis breast reconstruction group, 45 in the latissimus dorsi±prosthesis breast reconstruction group).
Collecting data includes encompassing demographics (e.g., age, BMI, breast ptosis), medical history (e.g., comorbidities, prior surgeries, family cancer history), oncological profiles (e.g., tumor type, size, location, stage, immunohistochemistry, nodal status, neoadjuvant/adjuvant therapies), and surgical details (e.g., procedure type, operative time, intraoperative blood loss, margin status, gland resection weight, implant size, drainage placement) from preoperatively to postoperatively. Postoperative follow-ups at 1 month, 6 months, 1 year will document complications, cosmesis (BREAST-Q, SCAR-Q, QLQ-BR45, Harris and Ueda assessments). Complications are recorded per patient, with events classified as major, minor, or any using the Clavien-Dindo grading system (Grades I-II: minor; III-IV: major). BREAST-Q/SCAR-Q/QLQ-BR45 questionnaires will be completed preoperatively and at 6 months/12 months postoperatively, alongside Harris and Ueda assessments and standardized breast photography (anteroposterior, lateral, oblique views).
An interim analysis will occur 1 year after study initiation and 1 month post-enrollment completion. Final analysis follows 1-year postoperative follow-up for all participants. Categorical variables will be analyzed using chi-square or Fisher's exact tests; continuous variables via t-tests, ANOVA, or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. Survival outcomes will employ Kaplan-Meier curves with log-rank testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | – | Procedure: Surgery optionsDelayed Endoscopic DTI Breast Reconstruction |
| Control group 2 | – | Procedure: Surgery optionsLatissimus dorsi ± impalnt Breast Reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Collecting the data of breast cancer patients who visited our hospital and the cooperative units from 2026 to 2027.
Key inclusion criteria (3 listed)
- Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer;
- Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy;
- Patients who are able and willing to sign the informed consent form.
Key exclusion criteria (6 listed)
- Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis;
- Patients who had the pectoralis major muscle resected during the initial mastectomy;
- History of thoracic or back surgery with suspected damage to the thoracodorsal vessels;
- Poor general condition and inability to tolerate surgery;
- Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking;
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 |
|---|---|---|
| Surgery optionsThe different surgery options for patients Post-Mastectomy | Procedure or surgery | Control group 1, Control group 2 |
Primary outcome
Aesthetic outcome evaluation--BREAST-Q scores
Time frame: Preoperative (baseline), 1-year postoperative
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
10 secondary outcomes
Complications
Time frame: 1 year postoperative
Surgical time
Time frame: Intraoperative
surgical-related costs
Time frame: perioperative
the rate of contralateral breast adjustment surgery
Time frame: perioperative
Quality of Life--BREAST-Q scores
Time frame: 1 year postoperative
Aesthetic outcome evaluation--Harris score
Time frame: 1-year postoperative
Aesthetic outcome evaluation--Ueda score
Time frame: 1-year postoperative
Quality of Life--EORTC Quality of Life scores
Time frame: 1-year postoperative
Scar assessment--SCAR-Q scales
Time frame: 1-year postoperative
Aesthetic outcome evaluation--aesthetic complications
Time frame: 1-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 11 Aug 2026.
- Background: PubMed 29926096Santosa KB, Qi J, Kim HM, Hamill JB, Wilkins EG, Pusic AL. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):891-899. doi: 10.1001/jamasurg.2018.1677.
- Background: PubMed 29926077Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.
- Background: PubMed 25876011Jagsi R, Jiang J, Momoh AO, Alderman A, Giordano SH, Buchholz TA, Pierce LJ, Kronowitz SJ, Smith BD. Complications After Mastectomy and Immediate Breast Reconstruction for Breast Cancer: A Claims-Based Analysis. Ann Surg. 2016 Feb;263(2):219-27. doi: 10.1097/SLA.0000000000001177.
- Background: PubMed 37380747Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.
- Background: PubMed 33346535Min K, Jeon DN, Han HH, Kim EK, Eom JS. Inframammary Fold Approach for Second-stage Operation in Expander-Implant Breast Reconstruction. Ann Plast Surg. 2021 Nov 1;87(5):501-505. doi: 10.1097/SAP.0000000000002629.
- Background: PubMed 37410610Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.
- Background: PubMed 32333626Yang B, Ren G, Song E, Pan D, Zhang J, Wang Y, Liao N, Tang J, Wang X, Cui S, Jin F, Geng C, Sun Q, Li H, Fan Z, Cao X, Wang H, Wang S, Shao Z, Wu J. Current Status and Factors Influencing Surgical Options for Breast Cancer in China: A Nationwide Cross-Sectional Survey of 110 Hospitals. Oncologist. 2020 Oct;25(10):e1473-e1480. doi: 10.1634/theoncologist.2020-0001. Epub 2020 May 13.
- Background: PubMed 35558511Zhao R, Jin M, Gao J, Zhang L, Tao L, Bao X. A Cross-Sectional Study of Breast Cancer Surgery and the Cost Based on Data From 77 Chinese 3A Hospitals in 2015. Front Oncol. 2022 Apr 26;12:857359. doi: 10.3389/fonc.2022.857359. eCollection 2022.
- Background: PubMed 39238088Sun K, Zhang B, Lei S, Zheng R, Liang X, Li L, Feng X, Zhang S, Zeng H, Yao Y, Ma P, Wang S, Chen R, Han B, Wei W, He J. Incidence, mortality, and disability-adjusted life years of female breast cancer in China, 2022. Chin Med J (Engl). 2024 Oct 20;137(20):2429-2436. doi: 10.1097/CM9.0000000000003278. Epub 2024 Sep 5.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- 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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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Du Zhenggui 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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 Zhenggui Du (+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?
Aesthetic outcome evaluation--BREAST-Q scores (time frame: Preoperative (baseline), 1-year 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 NCT07757074, which also lists 10 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 11 Aug 2026.