Breast CarcinomaNCT04688697
Prepectoral and Subpectoral Implant-based Breast Reconstruction
A study testing prepectoral implant-based reconstruction and subpectoral implant-based reconstruction in people with Breast Carcinoma and Breast Reconstruction, run by Fudan University at 1 site in China.
Trial summary
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Reconstruction
- What is being tested?
- prepectoral implant-based reconstruction and subpectoral implant-based reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to 31 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old
- Female
- Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
- Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
- Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
- No clinical or imaging evidence of distant metastasis
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- Patients to receive skin sparing mastectomy or nipple sparing mastectomy
- BMI < 35
- Patients with no or mild mastoptosis
- Prosthesis to be implanted <500 ml
- Be able and willing to sign the Informed Consent Form (ICF)
Who cannot join
- Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
- BMI>=35
- Patients who have received symmetrical breast surgery on the unaffected side immediately or later
- Patients with locally advanced breast cancer to receive neoadjuvant therapy
- Patients currently participating in other clinical trials, which may have impact on the participation in this trial
- Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
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- Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
- Pregnancy breast-feeding women
- History of smoking
- Previous history of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric, Open-labeled, Prospective, Randomized Controlled Study to Compare the Satisfaction and Safety of the Prepectoral and Subpectoral Implant-based Breast Reconstruction in Patients Receiving Immediate Breast Reconstruction Using Implant Combined With TiLoop® Bra After Skin Sparing or Nipple-areola Sparing Mastectomy
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast reconstruction due to its less injury, shorter time of operation and relatively simple surgical technique. In the long-term clinical practice, due to the lack of safe and effective alternative methods, the reconstruction method with prosthesis placed to posterior pectoralis major has been accepted by surgeons and patients, and has become the most commonly used method of prosthesis construction. However, the development of biomaterials provides new ideas for breast reconstruction. At present, more and more doctors in clinical practice discontinue the use of serratus anterior, but use the synthetic mesh (mostly titanium mesh TiLoop® Bra) or allogeneic acellular dermal matrix mesh to cover part of the dilator or prosthesis so as to shorten the entire operation cycle and make the appearance of the reconstructed breast more natural and aesthetic. In particular, it can improve the contour of the folds under the breast and shape the breasts with a certain degree of sagging.
This study takes the patients receiving immediate reconstruction with an implant combined with TiLoop® Bra after total mastectomy as the subjects, aiming to compare the aesthetics and safety of the placement of implant to anterior and posterior pectoralis major through a prospective and randomized study. The primary objective of the study is to analyze the aesthetics of breast appearance, patient satisfaction and postoperative quality of life (QOL) of the placement of implant to anterior and posterior pectoralis major. The secondary objective of the study is to analyze the incidence of complications and type of reoperation in both groups.
- Conditions
- Breast Carcinoma, Breast Reconstruction
- Being tested
- prepectoral implant-based reconstruction, subpectoral implant-based reconstruction
- Keywords
- breast carcinoma, breast reconstruction, Prepectoral prosthetic breast reconstruction, Complication
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prepectoral implant-based reconstructionProcedure or surgery
In this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major.
subpectoral implant-based reconstructionProcedure or surgery
In this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant.
| Study group | Role | What they receive |
|---|---|---|
| Prepectoral Group | Experimental | Prepectoral implant-based reconstruction applied for patients in this group Receives: Procedure: prepectoral implant-based reconstruction |
| Subpectoral Group | Active comparator | Subpectoral implant-based reconstruction applied for patients in this group Receives: Procedure: subpectoral implant-based reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction
Patients' satisfaction evaluated based on Breast-Q scale
Measured: 18 months after the operation
Secondary outcomes (1)
Incidences of complications and serious complications
Incidences of complications and serious complications
Measured: During 18 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start12 May 2021
- Primary completion27 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688697
- Sponsor's protocol ID
- PSIBBR
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Open-labeled, Prospective, Randomized Controlled Study to Compare the Satisfaction and Safety of the Prepectoral and Subpectoral Implant-based Breast Reconstruction in Patients Receiving Immediate Breast Reconstruction Using Implant Combined With TiLoop® Bra After Skin Sparing or Nipple-areola Sparing Mastectomy
- ClinicalTrials.gov ID
- NCT04688697
- Acronym / sponsor ID
- PSIBBR
- Conditions
- Breast Carcinoma, Breast Reconstruction
- Keywords
- breast carcinoma, breast reconstruction, Prepectoral prosthetic breast reconstruction, Complication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Dec 2020 (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 one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast reconstruction due to its less injury, shorter time of operation and relatively simple surgical technique. In the long-term clinical practice, due to the lack of safe and effective alternative methods, the reconstruction method with prosthesis placed to posterior pectoralis major has been accepted by surgeons and patients, and has become the most commonly used method of prosthesis construction. However, the development of biomaterials provides new ideas for breast reconstruction. At present, more and more doctors in clinical practice discontinue the use of serratus anterior, but use the synthetic mesh (mostly titanium mesh TiLoop® Bra) or allogeneic acellular dermal matrix mesh to cover part of the dilator or prosthesis so as to shorten the entire operation cycle and make the appearance of the reconstructed breast more natural and aesthetic. In particular, it can improve the contour of the folds under the breast and shape the breasts with a certain degree of sagging.
This study takes the patients receiving immediate reconstruction with an implant combined with TiLoop® Bra after total mastectomy as the subjects, aiming to compare the aesthetics and safety of the placement of implant to anterior and posterior pectoralis major through a prospective and randomized study. The primary objective of the study is to analyze the aesthetics of breast appearance, patient satisfaction and postoperative quality of life (QOL) of the placement of implant to anterior and posterior pectoralis major. The secondary objective of the study is to analyze the incidence of complications and type of reoperation in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepectoral Group | Experimental | Procedure: prepectoral implant-based reconstructionPrepectoral implant-based reconstruction applied for patients in this group |
| Subpectoral Group | Active comparator | Procedure: subpectoral implant-based reconstructionSubpectoral implant-based reconstruction applied for patients in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- More than 18 years old
- Female
- Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
- Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
- Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
Key exclusion criteria (10 listed)
- Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
- BMI>=35
- Patients who have received symmetrical breast surgery on the unaffected side immediately or later
- Patients with locally advanced breast cancer to receive neoadjuvant therapy
- Patients currently participating in other clinical trials, which may have impact on the participation in this trial
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 |
|---|---|---|
| prepectoral implant-based reconstructionIn this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major. | Procedure or surgery | Prepectoral Group |
| subpectoral implant-based reconstructionIn this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant. | Procedure or surgery | Subpectoral Group |
Primary outcome
Patients' satisfaction
Time frame: 18 months after the operation
Patients' satisfaction evaluated based on Breast-Q scale
1 secondary outcome
Incidences of complications and serious complications
Time frame: During 18 months after the operation
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 Apr 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prepectoral implant-based reconstruction and subpectoral implant-based reconstruction in people with Breast Carcinoma and Breast Reconstruction, run by Fudan University 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 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' satisfaction (time frame: 18 months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025.