Breast CancerPhase 2NCT06993714
3D-printed Biodegradable Breast Implants for Breast Restoration
A Phase 2 study testing Breast restoration surgery based on 3D printed degradable biological implants, Traditional breast-conserving surgery and Traditional silicone prosthesis breast reconstruction in people with Breast Cancer and Breast Reconstruction, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction
- What is being tested?
- Breast restoration surgery based on 3D printed degradable biological implants, Traditional breast-conserving surgery and Traditional silicone prosthesis breast reconstruction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
- Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
- Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
- ECOG performance status score: 0-1.
- If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
- Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.
Who cannot join
- Age > 70 years.
- Newly diagnosed stage IV metastatic breast cancer.
- Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
- Tumor invasion of the papillary areola complex.
- Inability to accept/tolerate radiotherapy.
- Breast cancer during pregnancy.
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- History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
- Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
- Patients deemed unsuitable for participation by the researchers.
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
Xijing hospital
Xi'an, Shaanxi, 710032
Ju liang J L Zhang, 029-84775271, vascularzhang@163.com
About this study
Official title: A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is:
Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction?
Read more
Participants will:
Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.
Read the detailed description
This is a prospective, multicenter, controlled clinical study divided into three groups. The experimental group receives breast reconstruction using 3D-printed biodegradable material breast implants, while the control groups undergo traditional breast-conserving surgery or breast reconstruction with silicone implants.
After providing full informed consent, subjects voluntarily choose their surgical approach, sign the informed consent form, and enter the trial period after passing screening. The specific treatment protocols are as follows:
- Preoperative Patient-Reported Outcome Assessment: The Chinese version of the BREAST-Q V2.0 scale is used to evaluate breast aesthetics, satisfaction, and quality of life, with calculation of the Q-score.
- Imaging Assessment: Enrolled patients undergo preoperative thin-slice breast magnetic resonance imaging (MRI), including conventional plain scan (SE T1WI sequence) and 3D dynamic contrast-enhanced scanning (FLASH sequence) to obtain three-dimensional enhanced images.
- Surgical Simulation, Design, and 3D Printing of Fillers for the Experimental Group: Three-dimensional model data of the breast tissue to be resected are acquired via MRI scanning. The Mimics software is used to extract models of diseased and healthy tissues for surgical planning. Subsequently, Geomagic and 3-matic software are employed to design the breast filler model, which is optimized for mechanical properties, cell ingrowth conditions, and degradation time requirements. Finally, the breast implant model is layer-by-layer printed using polycaprolactone (PCL) as the material via selective laser sintering (SLS) technology, followed by sterilization for standby use.
- Surgery: Experimental Group: Tumors are resected through transverse arc, periareolar, or radial incisions to ensure negative margins, followed by axillary lymph node dissection or sentinel lymph node biopsy. The 3D-printed filler is then implanted and sutured in place. Control Groups: Conventional breast-conserving surgery or nipple-areola-preserving subcutaneous gland resection combined with simultaneous breast reconstruction using implants is performed according to clinical routines. Incision types are selected by the surgeon. Tissue behind the nipple is sent for intraoperative pathological examination, and patch application is decided as needed.
- Postoperative Managemen: Wound dressing changes are performed on schedule, and the occurrence of complications or adverse reactions (e.g., infection) is recorded.
- Postoperative Systemic Therapy: Systemic chemotherapy or endocrine therapy is administered according to standard protocols. All patients in the experimental group receive local radiotherapy following the regimen for conventional breast-conserving surgery, including boost irradiation to the tumor bed. Radiotherapy for the control groups is decided according to current clinical guidelines and specifications.
- Postoperative Follow-Up Imaging and Assessments: Ultrasound Examinations: Routine breast ultrasound is conducted weekly within the first postoperative month, then monthly thereafter, to record changes in blood supply in the filler area. Full-volume breast ultrasound is performed every 3 months. MRI Examinations and PRO Assessments: MRI is conducted at 3, 6, 12, and 24 months postoperatively. Concurrently, the Chinese version of the BREAST-Q V2.0 scale is used to evaluate breast aesthetics, satisfaction, and quality of life, with calculation of the Q-score.
- Database Follow-Up:
Telephone follow-ups are conducted once monthly, and in-person follow-ups are conducted once every 3 months.
- Conditions
- Breast Cancer, Breast Reconstruction
- Being tested
- Breast restoration surgery based on 3D printed degradable biological implants, Traditional breast-conserving surgery, Traditional silicone prosthesis breast reconstruction
- Keywords
- 3D printing, Immediate breast reconstruction, biodegradable scaffold
- 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 restoration surgery based on 3D printed degradable biological implantsProcedure or surgery
In the experimental group, the surgeon makes an incision on the skin and creates an electrosurgical free flap with a thickness of approximately 3mm. Based on the tumor size simulated by the computer and combined with real-time exploration during the operation, the tumor is resected. The incision margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the resected specimen. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are excluded from the clinical trial). Corresponding surgical treatment is provided. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The wound is soaked and rinsed, hemostasis is thoroughly achieved, the designed 3D printed filler is implanted, and sutured and fixed. After placing the drainage, the skin is sutured layer by layer. The corresponding operation time is recorde.
Traditional breast-conserving surgeryProcedure or surgery
In the control group undergoing traditional breast - saving surgery, tumor segment resection is performed according to the clinical routine. The resection margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the circumferential specimens after resection. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative resection margin. The volume of the resected part during the intraoperative section is replaced by autologous tissue. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The corresponding operation time is recorded.
Traditional silicone prosthesis breast reconstructionProcedure or surgery
In the control group of traditional prosthesis reconstruction, subcutaneous gland resection with nipple and areola preservation combined with prosthesis for concurrent breast reconstruction is carried out according to the clinical routine. The incision method is selected by the surgeon. During the operation, the tissue behind the nipple is sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are considered out of the clinical trial and given corresponding surgical treatment), and the surgeon decides whether to use the patch in combination. The corresponding operation time is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Breast restoration surgery based on 3D printed degradable biological implants | Experimental | The patient will undergo breast reduction surgery based on 3D-printed degradable biological implants Receives: Procedure: Breast restoration surgery based on 3D printed degradable biological implants |
| Traditional breast-conserving surgery | Active comparator | The patient will undergo traditional breast-conserving surgery Receives: Procedure: Traditional breast-conserving surgery |
| Traditional silicone prosthesis breast reconstruction | Active comparator | The patient will undergo traditional silicone prosthesis breast reconstruction Receives: Procedure: Traditional silicone prosthesis breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cosmetic effects and quality of life
Patient satisfaction in the reconstruction module of the BREAST-Q scale is used for scoring, including: satisfaction with the breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score is the main endpoint of this study. After the BREAST-Q questionnaire is completed, its score is calculated and called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score, and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial, and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.
Measured: One year after the operation
Secondary outcomes (4)
Recurrence-free survival (RFS)
Imaging examinations confirm recurrence at the ipsilateral breast, ipsilateral chest wall or skin, and surgical scar sites. The date of the earliest discovered imaging examination is defined as the "local recurrence date".
When local recurrence is diagnosed through clinical history and physical examination findings, the date of clinical "local recurrence" is determined as the "local recurrence day".
In cases where local recurrence is diagnosed through cytology or tissue biopsy pathology, the earliest date of cytology or tissue biopsy pathology examination shall be regarded as the "local recurrence date".
The time starting from the day of the surgery and ending from the date of disease recurrence/death. In the case where neither death nor tumor recurrence was observed through follow-up, the final date for confirming no recurrence was reached.
Only an increase in relevant tumor markers such as CEA cannot be diagnosed as recurrence.
Measured: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Disease-free survival (DFS)
The time starting from the day of the surgery and ending from the date of tumor recurrence (if the specific date of tumor recurrence is unknown, the date of death due to the tumor is taken as the ending point). In the case where neither death nor tumor recurrence is followed up and observed, the final date for confirming no recurrence (the final recurrence-free survival confirmation date: the last date among the outpatient visit date or the examination date) is used up.
Measured: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Overall survival (OS)
The time between taking the day of the surgery as the starting point and deaths caused by various reasons as the ending point (when no death occurs, the time of the last follow-up is the ending point). In the case of survival, until the final date of survival confirmation. In cases where follow-up and tracking are not possible, the period ends on the last date when survival is confirmed before follow-up and tracking cannot be conducted.
Measured: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Surgical technique safety (incidence of complications)
Intraoperative complications encompass, but are not restricted to, intraoperative bleeding, vital blood vessel injury, subcutaneous emphysema, etc. Their incidence is calculated by using the total number of patients undergoing surgical treatment as the denominator and the number of patients experiencing any intraoperative complication as the numerator.
Postoperative complications include, but are not limited to, infection, flap or nipple-areola necrosis, abnormal sensation in the surgical site, and prosthesis-related complications. Similarly, the calculation of their occurrence rate involves taking the total number of surgically treated patients as the denominator and the number of patients with any postoperative complication as the numerator.
Regarding the rate of unplanned secondary surgeries, it is determined by using the total number of patients who received surgical treatment as the denominator and the number of patients undergoing unplanned secondary surgeries as the numerator.
Measured: Immediately after the operation, and at 3 days, 7 days, 10 days, 14 days, 1 month, 3 months, 6 months, 12 months and 24 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 posted29 May 2025
- Study start1 May 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Breast restoration surgery based on 3D printed degradable biological implants Control Group 1: Traditional breast-conserving surgery Control Group 2: Traditional silicone prosthesis breast reconstruction
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993714
- Sponsor's protocol ID
- KY20252204-C-1
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mu X, Zhang J, Jiang Y. 3D Printing in Breast Reconstruction: From Bench to Bed. Front Surg. 2021 May 20;8:641370. doi: 10.3389/fsurg.2021.641370. eCollection 2021.
PubMed 34095200
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration
- ClinicalTrials.gov ID
- NCT06993714
- Acronym / sponsor ID
- KY20252204-C-1
- Conditions
- Breast Cancer, Breast Reconstruction
- Keywords
- 3D printing, Immediate breast reconstruction, biodegradable scaffold
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (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.
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is:
Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction?
Participants will:
Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.
Detailed description
This is a prospective, multicenter, controlled clinical study divided into three groups. The experimental group receives breast reconstruction using 3D-printed biodegradable material breast implants, while the control groups undergo traditional breast-conserving surgery or breast reconstruction with silicone implants.
After providing full informed consent, subjects voluntarily choose their surgical approach, sign the informed consent form, and enter the trial period after passing screening. The specific treatment protocols are as follows:
- Preoperative Patient-Reported Outcome Assessment: The Chinese version of the BREAST-Q V2.0 scale is used to evaluate breast aesthetics, satisfaction, and quality of life, with calculation of the Q-score.
- Imaging Assessment: Enrolled patients undergo preoperative thin-slice breast magnetic resonance imaging (MRI), including conventional plain scan (SE T1WI sequence) and 3D dynamic contrast-enhanced scanning (FLASH sequence) to obtain three-dimensional enhanced images.
- Surgical Simulation, Design, and 3D Printing of Fillers for the Experimental Group: Three-dimensional model data of the breast tissue to be resected are acquired via MRI scanning. The Mimics software is used to extract models of diseased and healthy tissues for surgical planning. Subsequently, Geomagic and 3-matic software are employed to design the breast filler model, which is optimized for mechanical properties, cell ingrowth conditions, and degradation time requirements. Finally, the breast implant model is layer-by-layer printed using polycaprolactone (PCL) as the material via selective laser sintering (SLS) technology, followed by sterilization for standby use.
- Surgery: Experimental Group: Tumors are resected through transverse arc, periareolar, or radial incisions to ensure negative margins, followed by axillary lymph node dissection or sentinel lymph node biopsy. The 3D-printed filler is then implanted and sutured in place. Control Groups: Conventional breast-conserving surgery or nipple-areola-preserving subcutaneous gland resection combined with simultaneous breast reconstruction using implants is performed according to clinical routines. Incision types are selected by the surgeon. Tissue behind the nipple is sent for intraoperative pathological examination, and patch application is decided as needed.
- Postoperative Managemen: Wound dressing changes are performed on schedule, and the occurrence of complications or adverse reactions (e.g., infection) is recorded.
- Postoperative Systemic Therapy: Systemic chemotherapy or endocrine therapy is administered according to standard protocols. All patients in the experimental group receive local radiotherapy following the regimen for conventional breast-conserving surgery, including boost irradiation to the tumor bed. Radiotherapy for the control groups is decided according to current clinical guidelines and specifications.
- Postoperative Follow-Up Imaging and Assessments: Ultrasound Examinations: Routine breast ultrasound is conducted weekly within the first postoperative month, then monthly thereafter, to record changes in blood supply in the filler area. Full-volume breast ultrasound is performed every 3 months. MRI Examinations and PRO Assessments: MRI is conducted at 3, 6, 12, and 24 months postoperatively. Concurrently, the Chinese version of the BREAST-Q V2.0 scale is used to evaluate breast aesthetics, satisfaction, and quality of life, with calculation of the Q-score.
- Database Follow-Up:
Telephone follow-ups are conducted once monthly, and in-person follow-ups are conducted once every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental group: Breast restoration surgery based on 3D printed degradable biological implants Control Group 1: Traditional breast-conserving surgery Control Group 2: Traditional silicone prosthesis breast reconstruction
| Arm | Type | Receives |
|---|---|---|
| Breast restoration surgery based on 3D printed degradable biological implants | Experimental | Procedure: Breast restoration surgery based on 3D printed degradable biological implantsThe patient will undergo breast reduction surgery based on 3D-printed degradable biological implants |
| Traditional breast-conserving surgery | Active comparator | Procedure: Traditional breast-conserving surgeryThe patient will undergo traditional breast-conserving surgery |
| Traditional silicone prosthesis breast reconstruction | Active comparator | Procedure: Traditional silicone prosthesis breast reconstructionThe patient will undergo traditional silicone prosthesis 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 (6 listed)
- Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
- Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
- Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
- ECOG performance status score: 0-1.
- If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
Key exclusion criteria (9 listed)
- Age > 70 years.
- Newly diagnosed stage IV metastatic breast cancer.
- Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
- Tumor invasion of the papillary areola complex.
- Inability to accept/tolerate radiotherapy.
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 restoration surgery based on 3D printed degradable biological implantsIn the experimental group, the surgeon makes an incision on the skin and creates an electrosurgical free flap with a thickness of approximately 3mm. Based on the tumor size simulated by the computer and combined with real-time exploration during the operation, the tumor is resected. The incision margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the resected specimen. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are excluded from the clinical trial). Corresponding surgical treatment is provided. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The wound is soaked and rinsed, hemostasis is thoroughly achieved, the designed 3D printed filler is implanted, and sutured and fixed. After placing the drainage, the skin is sutured layer by layer. The corresponding operation time is recorde. | Procedure or surgery | Breast restoration surgery based on 3D printed degradable biological implants |
| Traditional breast-conserving surgeryIn the control group undergoing traditional breast - saving surgery, tumor segment resection is performed according to the clinical routine. The resection margin is more than 1cm away from the tumor boundary. Eight to ten points are selected at equal intervals around the circumferential specimens after resection. Samples are taken and sent for frozen tissue pathological section examination to ensure a negative resection margin. The volume of the resected part during the intraoperative section is replaced by autologous tissue. Axillary lymph node dissection or sentinel lymph node biopsy is routinely performed. The corresponding operation time is recorded. | Procedure or surgery | Traditional breast-conserving surgery |
| Traditional silicone prosthesis breast reconstructionIn the control group of traditional prosthesis reconstruction, subcutaneous gland resection with nipple and areola preservation combined with prosthesis for concurrent breast reconstruction is carried out according to the clinical routine. The incision method is selected by the surgeon. During the operation, the tissue behind the nipple is sent for frozen tissue pathological section examination to ensure a negative incision margin (those with a positive incision margin are considered out of the clinical trial and given corresponding surgical treatment), and the surgeon decides whether to use the patch in combination. The corresponding operation time is recorded. | Procedure or surgery | Traditional silicone prosthesis breast reconstruction |
Primary outcome
Postoperative cosmetic effects and quality of life
Time frame: One year after the operation
Patient satisfaction in the reconstruction module of the BREAST-Q scale is used for scoring, including: satisfaction with the breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score is the main endpoint of this study. After the BREAST-Q questionnaire is completed, its score is calculated and called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score, and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial, and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.
4 secondary outcomes
Recurrence-free survival (RFS)
Time frame: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Disease-free survival (DFS)
Time frame: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Overall survival (OS)
Time frame: Three months, half a year, one year after the operation, and then once a year thereafter until ten years
Surgical technique safety (incidence of complications)
Time frame: Immediately after the operation, and at 3 days, 7 days, 10 days, 14 days, 1 month, 3 months, 6 months, 12 months and 24 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 6 Jun 2025.
- Background: PubMed 34095200Mu X, Zhang J, Jiang Y. 3D Printing in Breast Reconstruction: From Bench to Bed. Front Surg. 2021 May 20;8:641370. doi: 10.3389/fsurg.2021.641370. eCollection 2021.
- Individual participant dataSharing planned: 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Breast restoration surgery based on 3D printed degradable biological implants, Traditional breast-conserving surgery and Traditional silicone prosthesis breast reconstruction in people with Breast Cancer and Breast Reconstruction, run by Xijing 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 6 inclusion and 9 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 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ju liang J L Zhang (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cosmetic effects and quality of life (time frame: One year after the operation). 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 NCT06993714, which also lists 1 linked publication.
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 6 Jun 2025.