Breast Cancer PatientsNCT07037576
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
An observational study of Breast Cancer Patients, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients 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?
- Breast Reconstruction Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Mar 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: Treatment-naïve women with unilateral primary breast cancer (clinical stage cT1-3N0-3M0) scheduled for immediate prepectoral direct-to-implant reconstruction OR tissue expander/implant two-stage reconstruction, followed by adjuvant radiotherapy.
Who may be able to join
- women aged 18 to 70；
- Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup；
- adjuvant radiotherapy is required;
- Patients scheduled to undergo nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral implant-based reconstruction (via open, endoscopic, or robotic approach) require adjuvant radiotherapy AFTER permanent implant placement; OR Patients scheduled for NSM/SSM with two-stage tissue expander/implant reconstruction (with expander placement in either submuscular or prepectoral plane) receive radiotherapy WITH the tissue expander in situ, followed by exchange for permanent implant ≥6 months post-radiotherapy (expander position: submuscular/prepectoral acceptable; surgical approach: open/endoscopic/robotic acceptable);
- Patients are eligible regardless of whether mesh is used in the reconstruction surgery;
- Patients with severe breast ptosis are eligible;
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- During the study observation period, lipofilling is permitted on the affected breast and symmetrization procedures on the contralateral breast in both cohorts;
- ECOG performance status 0-1;
- Patients receiving neoadjuvant chemotherapy (NACT) are eligible;
- Bilateral breast reconstruction is permitted;
- No smoking history OR smoking cessation ≥4 weeks prior to enrollment;
- Investigator-confirmed protocol compliance capability;
- Concurrent participation in other interventional/non-interventional trials is allowed if deemed non-interfering by the investigator;
- Voluntarily participate and sign the informed consent form after comprehensive understanding.
Who cannot join
- Stage IV (metastatic) breast cancer;
- No prior radiotherapy post-mastectomy;
- History of ipsilateral chest wall/axillary radiation therapy;
- Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use;
- Inflammatory breast cancer (cT4d);
- Autologous-based breast reconstruction or delayed reconstruction;
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- Severe cardiopulmonary/hepatic/renal comorbidities contraindicating surgery/radiotherapy (ASA class ≥III);
- Psychiatric disorders precluding independent BREAST-Q completion;
- Pregnancy or lactation;
- Documented history of protocol non-adherence;
- Life-limiting comorbidities interfering with treatment OR investigator-determined ineligibility.
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, 1 recruiting
- Recruiting
Henan cacer hospital
Henan, Henan, 450008
Chen chun
About this study
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients
Read the detailed description
This study is a prospective, double-cohort study. It plans to enroll more than 104 patients with cT1-3N0-3M0 breast cancer for immediate prepectoral muscle prosthesis reconstruction or two-step breast reconstruction with expander/prosthesis, and they will receive postoperative radiotherapy. Record the changes of BREAST-Q scores of the patients before and after the operation, as well as information such as postoperative complications and capsular contracture.
The primary endpoint was the BREAST-Q score at 12 months after the operation. The secondary endpoints included the success rate of breast reconstruction, surgical complications, cosmetic effects of the breast evaluated by doctors, the occurrence of capsular contracture, nipple and skin sensation, and tumor safety.
- Conditions
- Breast Cancer Patients
- Being tested
- Breast Reconstruction Surgery
- Keywords
- Breast cancer, Breast reconstruction surgery, Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction SurgeryProcedure or surgery
Also called radiation
Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort | Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral prosthetic breast reconstruction are eligible for inclusion, regardless of mesh use (with or without mesh). Approaches including open, endoscopic, or robotic techniques are acceptable, provided that adjuvant radiotherapy is administered after permanent implant placement. Receives: Procedure: Breast Reconstruction Surgery | |
| Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort | Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with two-stage expander/implant breast reconstruction are eligible, provided that: Expander placement may be either prepectoral or subpectoral, Mesh use is optional (with or without acellular dermal matrix), Radiotherapy is administered with the expander in situ, Permanent implant exchange is performed ≥6 months after completing radiotherapy, The implant exchange procedure permits any approach (open, endoscopic, or robotic) and any plane/mesh configuration (prepectoral/subpectoral, with/without mesh). Receives: Procedure: Breast Reconstruction Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREAST-Q (Breast Reconstruction Module) Scores
This trial collects patient-reported outcomes through four domains of the BREAST-Q Breast Reconstruction Module: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Sexual Well-being. Scores are assessed preoperatively and at 12 months postoperatively. The BREAST-Q score at 12 months post-surgery serves as the primary endpoint.
Measured: Preoperatively and at 1 Year Postoperatively
Secondary outcomes (6)
Breast Reconstruction Failure Rate
Breast Reconstruction Failure Rate: Defined as the proportion of patients requiring implant removal due to complications among all patients undergoing breast reconstruction. Implant Removal Due to Complications: Refers to explantation occurring within 12 months postoperatively attributed to any of the following surgery-related complications: Hematoma, Seroma, Flap necrosis, Nipple-areolar complex (NAC) necrosis, Surgical site infection, Wound dehiscence, Implant exposure, Baker grade III/IV capsular contracture, Implant malposition/displacement. Exclusion Criterion: Implant removals requested by patients without objective surgery-related complications (i.e., subjectively motivated explantations) must be documented separately and excluded from failure rate calculations.
Measured: 1 Year Postoperatively
Complication Profile:
Includes but not limited to: Hematoma, Poor Wound Healing, Flap Necrosis, Surgical Site Infection, Wound Dehiscence, Fat Grafting-Associated Complications. All complications must be graded according to the Clavien-Dindo Classification System, then systematically assessed and documented.
Measured: 1 Year Postoperatively
Physician-Assessed Aesthetic Outcome
Evaluated by surgeons independent of the operating team using the Harris Scale to grade the aesthetic outcome of the reconstructed breast based on standardized patient photographs.
Measured: 1 Year Postoperatively
Capsular Contracture Assessment
Evaluated using the Baker Classification System (Spear \& Baker, 1995).
Measured: 1 Year Postoperatively
Nipple and Skin Sensation Assessment
Tactile sensation is evaluated using the Semmes-Weinstein Monofilament Examination (SWME).
Measured: 1 Year Postoperatively
Oncological Safety Endpoints: Disease-Free Survival (DFS) and Overall Survival (OS).
DFS: Time interval from the date of surgery to the occurrence of any recurrence (local/regional/distant metastasis), new primary breast cancer, or death from any cause, whichever occurs first. Patients without events are censored at the last documented disease-free follow-up.
OS: Time interval from the date of surgery to death from any cause. Living patients are censored at the last confirmed survival follow-up.
Measured: 5 Year Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start20 May 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- xiuchun chen, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037576
- Sponsor's protocol ID
- 2025-034
- Status last verified
- May 2025
- 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 33890886Chatterjee 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 29346711Li 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 31913902Sigalove 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 30842930Gabriel A, Maxwell GP. Prepectoral Breast Reconstruction in Challenging Patients. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):14S-21S. doi: 10.1097/PRS.0000000000004046.
PubMed 29166343Chopra S, Al-Ishaq Z, Vidya R. The Journey of Prepectoral Breast Reconstruction through Time. World J Plast Surg. 2021 May;10(2):3-13. doi: 10.29252/wjps.10.2.3.
PubMed 34307092Clemens MW, Kronowitz SJ. Acellular dermal matrix in irradiated tissue expander/implant-based breast reconstruction: evidence-based review. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):27S-34S. doi: 10.1097/PRS.0b013e318265f690.
PubMed 23096982Kronowitz SJ, Hunt KK, Kuerer HM, Babiera G, McNeese MD, Buchholz TA, Strom EA, Robb GL. Delayed-immediate breast reconstruction. Plast Reconstr Surg. 2004 May;113(6):1617-28. doi: 10.1097/01.prs.0000117192.54945.88.
PubMed 15114121Sbitany H, Gomez-Sanchez C, Piper M, Lentz R. Prepectoral Breast Reconstruction in the Setting of Postmastectomy Radiation Therapy: An Assessment of Clinical Outcomes and Benefits. Plast Reconstr Surg. 2019 Jan;143(1):10-20. doi: 10.1097/PRS.0000000000005140.
PubMed 30589770Garza RM, Paik KJ, Chung MT, Duscher D, Gurtner GC, Longaker MT, Wan DC. Studies in fat grafting: Part III. Fat grafting irradiated tissue--improved skin quality and decreased fat graft retention. Plast Reconstr Surg. 2014 Aug;134(2):249-257. doi: 10.1097/PRS.0000000000000326.
PubMed 25068325Cano SJ, Klassen AF, Scott AM, Cordeiro PG, Pusic AL. The BREAST-Q: further validation in independent clinical samples. Plast Reconstr Surg. 2012 Feb;129(2):293-302. doi: 10.1097/PRS.0b013e31823aec6b.
PubMed 22286412Voineskos SH, Nelson JA, Klassen AF, Pusic AL. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery. Annu Rev Med. 2018 Jan 29;69:467-479. doi: 10.1146/annurev-med-060116-022831.
PubMed 29414263
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
- ClinicalTrials.gov ID
- NCT07037576
- Acronym / sponsor ID
- 2025-034
- Conditions
- Breast Cancer Patients
- Keywords
- Breast cancer, Breast reconstruction surgery, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 25 Jun 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.
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients
Detailed description
This study is a prospective, double-cohort study. It plans to enroll more than 104 patients with cT1-3N0-3M0 breast cancer for immediate prepectoral muscle prosthesis reconstruction or two-step breast reconstruction with expander/prosthesis, and they will receive postoperative radiotherapy. Record the changes of BREAST-Q scores of the patients before and after the operation, as well as information such as postoperative complications and capsular contracture.
The primary endpoint was the BREAST-Q score at 12 months after the operation. The secondary endpoints included the success rate of breast reconstruction, surgical complications, cosmetic effects of the breast evaluated by doctors, the occurrence of capsular contracture, nipple and skin sensation, and tumor safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort | – | Procedure: Breast Reconstruction SurgeryPatients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral prosthetic breast reconstruction are eligible for inclusion, regardless of mesh use (with or without mesh). Approaches including open, endoscopic, or robotic techniques are acceptable, provided that adjuvant radiotherapy is administered after permanent implant placement. |
| Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort | – | Procedure: Breast Reconstruction SurgeryPatients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with two-stage expander/implant breast reconstruction are eligible, provided that: Expander placement may be either prepectoral or subpectoral, Mesh use is optional (with or without acellular dermal matrix), Radiotherapy is administered with the expander in situ, Permanent implant exchange is performed ≥6 months after completing radiotherapy, The implant exchange procedure permits any approach (open, endoscopic, or robotic) and any plane/mesh configuration (prepectoral/subpectoral, with/without mesh). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve women with unilateral primary breast cancer (clinical stage cT1-3N0-3M0) scheduled for immediate prepectoral direct-to-implant reconstruction OR tissue expander/implant two-stage reconstruction, followed by adjuvant radiotherapy.
Key inclusion criteria (14 listed)
- women aged 18 to 70；
- Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup；
- adjuvant radiotherapy is required;
- Patients scheduled to undergo nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral implant-based reconstruction (via open, endoscopic, or robotic approach) require adjuvant radiotherapy AFTER permanent implant placement; OR Patients scheduled for NSM/SSM with two-stage tissue expander/implant reconstruction (with expander placement in either submuscular or prepectoral plane) receive radiotherapy WITH the tissue expander in situ, followed by exchange for permanent implant ≥6 months post-radiotherapy (expander position: submuscular/prepectoral acceptable; surgical approach: open/endoscopic/robotic acceptable);
- Patients are eligible regardless of whether mesh is used in the reconstruction surgery;
Key exclusion criteria (11 listed)
- Stage IV (metastatic) breast cancer;
- No prior radiotherapy post-mastectomy;
- History of ipsilateral chest wall/axillary radiation therapy;
- Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use;
- Inflammatory breast cancer (cT4d);
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 |
|---|---|---|
| Breast Reconstruction SurgeryAlso: radiationBreast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy | Procedure or surgery | Delayed-Immediate Two-Stage Expander/Implant Breast Reconstruction Cohort, Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort |
Primary outcome
BREAST-Q (Breast Reconstruction Module) Scores
Time frame: Preoperatively and at 1 Year Postoperatively
This trial collects patient-reported outcomes through four domains of the BREAST-Q Breast Reconstruction Module: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Sexual Well-being. Scores are assessed preoperatively and at 12 months postoperatively. The BREAST-Q score at 12 months post-surgery serves as the primary endpoint.
6 secondary outcomes
Breast Reconstruction Failure Rate
Time frame: 1 Year Postoperatively
Complication Profile:
Time frame: 1 Year Postoperatively
Physician-Assessed Aesthetic Outcome
Time frame: 1 Year Postoperatively
Capsular Contracture Assessment
Time frame: 1 Year Postoperatively
Nipple and Skin Sensation Assessment
Time frame: 1 Year Postoperatively
Oncological Safety Endpoints: Disease-Free Survival (DFS) and Overall Survival (OS).
Time frame: 5 Year Postoperatively
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 25 Jun 2025.
- Results publication: PubMed 33890886Kraenzlin 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.
- Results publication: PubMed 29346711Chatterjee 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.
- Results publication: PubMed 31913902Li 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.
- Results publication: PubMed 30842930Sigalove S. Prepectoral breast reconstruction and radiotherapy-a closer look. Gland Surg. 2019 Feb;8(1):67-74. doi: 10.21037/gs.2019.01.01.
- Results publication: PubMed 29166343Gabriel A, Maxwell GP. Prepectoral Breast Reconstruction in Challenging Patients. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):14S-21S. doi: 10.1097/PRS.0000000000004046.
- Results publication: PubMed 34307092Chopra S, Al-Ishaq Z, Vidya R. The Journey of Prepectoral Breast Reconstruction through Time. World J Plast Surg. 2021 May;10(2):3-13. doi: 10.29252/wjps.10.2.3.
- Results publication: PubMed 23096982Clemens MW, Kronowitz SJ. Acellular dermal matrix in irradiated tissue expander/implant-based breast reconstruction: evidence-based review. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):27S-34S. doi: 10.1097/PRS.0b013e318265f690.
- Results publication: PubMed 15114121Kronowitz SJ, Hunt KK, Kuerer HM, Babiera G, McNeese MD, Buchholz TA, Strom EA, Robb GL. Delayed-immediate breast reconstruction. Plast Reconstr Surg. 2004 May;113(6):1617-28. doi: 10.1097/01.prs.0000117192.54945.88.
- Results publication: PubMed 30589770Sbitany H, Gomez-Sanchez C, Piper M, Lentz R. Prepectoral Breast Reconstruction in the Setting of Postmastectomy Radiation Therapy: An Assessment of Clinical Outcomes and Benefits. Plast Reconstr Surg. 2019 Jan;143(1):10-20. doi: 10.1097/PRS.0000000000005140.
- Results publication: PubMed 25068325Garza RM, Paik KJ, Chung MT, Duscher D, Gurtner GC, Longaker MT, Wan DC. Studies in fat grafting: Part III. Fat grafting irradiated tissue--improved skin quality and decreased fat graft retention. Plast Reconstr Surg. 2014 Aug;134(2):249-257. doi: 10.1097/PRS.0000000000000326.
- Results publication: PubMed 22286412Cano SJ, Klassen AF, Scott AM, Cordeiro PG, Pusic AL. The BREAST-Q: further validation in independent clinical samples. Plast Reconstr Surg. 2012 Feb;129(2):293-302. doi: 10.1097/PRS.0b013e31823aec6b.
- Results publication: PubMed 29414263Voineskos SH, Nelson JA, Klassen AF, Pusic AL. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery. Annu Rev Med. 2018 Jan 29;69:467-479. doi: 10.1146/annurev-med-060116-022831.
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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.
xiuchun chen study director
Henan Cancer Hospital
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 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 14 inclusion and 11 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?
BREAST-Q (Breast Reconstruction Module) Scores (time frame: Preoperatively and at 1 Year Postoperatively). 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 NCT07037576, which also lists 12 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.