Brest CancerNCT07782801
Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.
A study testing Radical mastectomy with axillary lymph node dissection, Immediate implant-based breast reconstruction and Acellular xenogeneic matrix (AXM) in people with Brest Cancer, run by National Research Oncology and Transplantology Center, Kazakhstan at 1 site in Kazakhstan.
Trial summary
In 2020, more than 31,000 new cancer cases were reported in Kazakhstan, with breast cancer being the most common type, accounting for more than 4,200 new cases. This pattern has also been observed in previous years, making breast cancer a major public health concern in the country. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Brest Cancer
- What is being tested?
- Radical mastectomy with axillary lymph node dissection, Immediate implant-based breast reconstruction and Acellular xenogeneic matrix (AXM)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with verified stage I-II breast cancer
- Age 18-65 years
- Absence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
- Absence of neurological or psychological deviations affecting capacity.
- Absence of pregnancy
- Absence of HIV, zoonotic infections.
- Absence of allergic reactions to materials or components included in ADM.
- Absence of concomitant oncological diseases, including oncohematological pathology.
Who cannot join
- Patients with unverified malignant breast tumors.
- Patients with stage III-IV malignant breast tumors.
- Age under 18 years
- Presence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
- Presence of neurological or psychological deviations affecting capacity.
- Pregnancy
Show all 14Show fewer
- HIV, zoonotic infections.
- Presence of allergic reactions to materials or components included in ADM.
- Presence of concomitant oncological diseases, including oncohematological pathology.
- Intolerance to ADM or its components.
- Medical indications arising during the study.
- Patient non-compliance (failure to comply with postoperative regimen).
- Cessation of therapy for more than 24 hours at the patient's request.
- Non-compliance with participation rules in the study.
Trial locations and contacts
1 site in 1 country.
About this study
In 2020, more than 31,000 new cancer cases were reported in Kazakhstan, with breast cancer being the most common type, accounting for more than 4,200 new cases. This pattern has also been observed in previous years, making breast cancer a major public health concern in the country.
Fortunately, approximately 94% of breast cancer cases are diagnosed at stages I-III, when treatment is generally possible. Nevertheless, treatment, particularly surgery, can be physically and emotionally challenging. Patients may develop postoperative complications such as scar contractures and lymphedema. In addition, breast loss can significantly affect body image, sense of femininity, psychological well-being, and social reintegration.
Read more
To improve functional and psychosocial outcomes, immediate breast reconstruction has become an important component of modern breast cancer surgery. Implant-based immediate reconstruction is widely used and can restore breast contour during the same surgical procedure as tumor removal.
However, implant-based reconstruction in breast cancer patients requires reliable fixation and coverage of the implant. Synthetic meshes are commonly used for this purpose, but they may be associated with complications such as inflammation, fibrosis, infection, and implant exposure.
An alternative approach is the use of biological materials derived from animal tissues, particularly acellular collagen matrices. These materials are designed to provide structural support while allowing integration with surrounding tissues. Their clinical performance, however, may vary depending on their biological origin and processing methods, and their high cost can limit their accessibility.
To address these limitations, Kazakhstani researchers developed a domestic acellular xenogeneic matrix (AXM) based on specially processed bovine peritoneum. The material has demonstrated promising results as a wound covering in preclinical and clinical studies, including applications involving implantation within the body.
The current research aims to evaluate whether AXM can be effectively used as a fixation material for breast implants in patients undergoing immediate breast reconstruction after breast cancer surgery. Because implant fixation requires sufficient mechanical strength and stable integration with surrounding tissues, further clinical evaluation is needed to establish the safety, reliability, and cost-effectiveness of AXM as a domestic alternative to commercially available biological matrices.
Read the detailed description
According to official statistical data for 2020, 31,505 new cases of cancer were registered in Kazakhstan. Among them, 4,272 were cases of malignant breast neoplasms, making breast cancer the most commonly diagnosed malignancy in the country. This trend has also been observed in previous years, highlighting breast cancer as an important public health concern.
Despite the fact that approximately 94.3% of breast cancer cases are diagnosed at stages I-III, when effective treatment is generally possible, treatment itself remains a significant challenge for patients. Surgical treatment may be associated with delayed complications such as scar contractures and lymphedema. From a psychosocial and quality-of-life perspective, breast loss may significantly affect body image, sense of femininity, psychological well-being, and social reintegration.
In modern breast oncology, immediate breast reconstruction with implants has become an important component of surgical treatment. However, implant-based reconstruction requires reliable fixation and adequate coverage of the implant. Synthetic meshes, including those based on polytetrafluoroethylene and other synthetic polymers, are commonly used for this purpose but may be associated with complications such as reactive inflammation, fibrosis, infection, and implant exposure.
As an alternative to synthetic materials, acellular collagen matrices of animal origin have been introduced into reconstructive breast surgery. These biological materials provide structural support and may facilitate integration with surrounding tissues. However, studies have demonstrated that xenogeneic matrices can differ substantially in their biological behavior depending on their tissue origin and processing methods. In addition, the high cost of commercially available matrices remains a significant limitation to their widespread use.
To address this issue, a group of Kazakhstani researchers developed and patented a domestic wound covering based on acellular bovine peritoneum, known as AXM. The material has demonstrated promising results as a wound covering in preclinical and clinical settings, including applications involving implantation within the body.
However, the use of AXM as a fixation material for breast implants represents a distinct clinical application. Unlike wound coverage, implant fixation requires the matrix to withstand mechanical tension and provide stable long-term support while integrating with the surrounding tissues. Given the differences in the biological and mechanical properties of xenogeneic matrices from different sources, the safety, effectiveness, and reliability of the domestic AXM as a fixation material for breast implants require further clinical evaluation.
- Conditions
- Brest Cancer
- Being tested
- Radical mastectomy with axillary lymph node dissection, Immediate implant-based breast reconstruction, Acellular xenogeneic matrix (AXM), Synthetic mesh prosthesis
- Keywords
- Decellularized xenomatrix, Breast reconstruction, Breast cancer, ADM, AXM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical mastectomy with axillary lymph node dissectionProcedure or surgery
Also called Study group (AXM)
Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session.
Immediate implant-based breast reconstructionProcedure or surgery
Also called Control group (synthetic mesh protstheses)
Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy.
Acellular xenogeneic matrix (AXM)Device
Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction.
Synthetic mesh prosthesisDevice
Synthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Postmastectomy immediate breast reconstruction using domestic AXM | Experimental | Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM. Receives: Procedure: Radical mastectomy with axillary lymph node dissection; Procedure: Immediate implant-based breast reconstruction; Device: Acellular xenogeneic matrix (AXM) |
| Postmastectomy immediate breast reconstruction using synthetic mesh prostheses. | Active comparator | Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using synthetic mesh prostheses. Receives: Procedure: Radical mastectomy with axillary lymph node dissection; Procedure: Immediate implant-based breast reconstruction; Device: Synthetic mesh prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
Proportion of participants with at least one postoperative complication after immediate implant-based breast reconstruction using acellular xenogeneic matrix or synthetic mesh prosthesis. Complications include surgical site infection, seroma, haematoma, skin or nipple-areola necrosis, wound dehiscence, implant exposure, capsular contracture and implant loss, graded according to the Clavien-Dindo classification.
Measured: 1, 3, 6, 12 and 24 months after surgery
Secondary outcomes (2)
Pain intensity measured by the Visual Analogue Scale (VAS)
Postoperative pain intensity assessed using the Visual Analogue Scale (VAS), an 11-point numeric scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain.
Measured: Postoperative day 3, day 7 and day 14
Health-related quality of life measured by the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Each of the eight domain scores ranges from 0 to 100, where 0 represents the worst and 100 the best possible health status. Higher scores indicate a better outcome.
Measured: 1, 3, 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start15 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brest 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Oncology and Transplantology Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bauyrzhan Anapiya, National Research Oncology and Transplantology Center, Kazakhstan
- Investigators
- Baurzhan Anapiya, Principal investigator, Baurzhan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782801
- Sponsor's protocol ID
- KazBreastRecAXM
- Other IDs
- BR24992950
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi YS, You HJ, Lee TY, Kim DW. Comparing Complications of Biologic and Synthetic Mesh in Breast Reconstruction: A Systematic Review and Network Meta-Analysis. Arch Plast Surg. 2023 Feb 6;50(1):3-9. doi: 10.1055/a-1964-8181. eCollection 2023 Jan.
PubMed 36755646Colwell AS. One- and two-stage prosthetic reconstruction in nipple-sparing mastectomy. In: Plastic Surgery. 4th ed. Vol. 5. Elsevier; 2018:233-246.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.
- ClinicalTrials.gov ID
- NCT07782801
- Acronym / sponsor ID
- KazBreastRecAXM
- Conditions
- Brest Cancer
- Keywords
- Decellularized xenomatrix, Breast reconstruction, Breast cancer, ADM, AXM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Research Oncology and Transplantology Center, KazakhstanUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 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.
In 2020, more than 31,000 new cancer cases were reported in Kazakhstan, with breast cancer being the most common type, accounting for more than 4,200 new cases. This pattern has also been observed in previous years, making breast cancer a major public health concern in the country.
Fortunately, approximately 94% of breast cancer cases are diagnosed at stages I-III, when treatment is generally possible. Nevertheless, treatment, particularly surgery, can be physically and emotionally challenging. Patients may develop postoperative complications such as scar contractures and lymphedema. In addition, breast loss can significantly affect body image, sense of femininity, psychological well-being, and social reintegration.
To improve functional and psychosocial outcomes, immediate breast reconstruction has become an important component of modern breast cancer surgery. Implant-based immediate reconstruction is widely used and can restore breast contour during the same surgical procedure as tumor removal.
However, implant-based reconstruction in breast cancer patients requires reliable fixation and coverage of the implant. Synthetic meshes are commonly used for this purpose, but they may be associated with complications such as inflammation, fibrosis, infection, and implant exposure.
An alternative approach is the use of biological materials derived from animal tissues, particularly acellular collagen matrices. These materials are designed to provide structural support while allowing integration with surrounding tissues. Their clinical performance, however, may vary depending on their biological origin and processing methods, and their high cost can limit their accessibility.
To address these limitations, Kazakhstani researchers developed a domestic acellular xenogeneic matrix (AXM) based on specially processed bovine peritoneum. The material has demonstrated promising results as a wound covering in preclinical and clinical studies, including applications involving implantation within the body.
The current research aims to evaluate whether AXM can be effectively used as a fixation material for breast implants in patients undergoing immediate breast reconstruction after breast cancer surgery. Because implant fixation requires sufficient mechanical strength and stable integration with surrounding tissues, further clinical evaluation is needed to establish the safety, reliability, and cost-effectiveness of AXM as a domestic alternative to commercially available biological matrices.
Detailed description
According to official statistical data for 2020, 31,505 new cases of cancer were registered in Kazakhstan. Among them, 4,272 were cases of malignant breast neoplasms, making breast cancer the most commonly diagnosed malignancy in the country. This trend has also been observed in previous years, highlighting breast cancer as an important public health concern.
Despite the fact that approximately 94.3% of breast cancer cases are diagnosed at stages I-III, when effective treatment is generally possible, treatment itself remains a significant challenge for patients. Surgical treatment may be associated with delayed complications such as scar contractures and lymphedema. From a psychosocial and quality-of-life perspective, breast loss may significantly affect body image, sense of femininity, psychological well-being, and social reintegration.
In modern breast oncology, immediate breast reconstruction with implants has become an important component of surgical treatment. However, implant-based reconstruction requires reliable fixation and adequate coverage of the implant. Synthetic meshes, including those based on polytetrafluoroethylene and other synthetic polymers, are commonly used for this purpose but may be associated with complications such as reactive inflammation, fibrosis, infection, and implant exposure.
As an alternative to synthetic materials, acellular collagen matrices of animal origin have been introduced into reconstructive breast surgery. These biological materials provide structural support and may facilitate integration with surrounding tissues. However, studies have demonstrated that xenogeneic matrices can differ substantially in their biological behavior depending on their tissue origin and processing methods. In addition, the high cost of commercially available matrices remains a significant limitation to their widespread use.
To address this issue, a group of Kazakhstani researchers developed and patented a domestic wound covering based on acellular bovine peritoneum, known as AXM. The material has demonstrated promising results as a wound covering in preclinical and clinical settings, including applications involving implantation within the body.
However, the use of AXM as a fixation material for breast implants represents a distinct clinical application. Unlike wound coverage, implant fixation requires the matrix to withstand mechanical tension and provide stable long-term support while integrating with the surrounding tissues. Given the differences in the biological and mechanical properties of xenogeneic matrices from different sources, the safety, effectiveness, and reliability of the domestic AXM as a fixation material for breast implants require further clinical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmastectomy immediate breast reconstruction using domestic AXM | Experimental | Procedure: Radical mastectomy with axillary lymph node dissection, Procedure: Immediate implant-based breast reconstruction, Device: Acellular xenogeneic matrix (AXM)Study subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using domestic AXM. |
| Postmastectomy immediate breast reconstruction using synthetic mesh prostheses. | Active comparator | Procedure: Radical mastectomy with axillary lymph node dissection, Procedure: Immediate implant-based breast reconstruction, Device: Synthetic mesh prosthesisStudy subjects undergoing radical mastectomy with lymph node dissection and immediate breast reconstruction using synthetic mesh prostheses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with verified stage I-II breast cancer
- Age 18-65 years
- Absence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
- Absence of neurological or psychological deviations affecting capacity.
- Absence of pregnancy
Key exclusion criteria (14 listed)
- Patients with unverified malignant breast tumors.
- Patients with stage III-IV malignant breast tumors.
- Age under 18 years
- Presence of accompanying endocrine, cardiovascular, or neurological pathologies in decompensation stage.
- Presence of neurological or psychological deviations affecting capacity.
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 |
|---|---|---|
| Radical mastectomy with axillary lymph node dissectionAlso: Study group (AXM)Radical mastectomy with axillary lymph node dissection performed as the oncological component of treatment, immediately followed by breast reconstruction in the same operative session. | Procedure or surgery | Postmastectomy immediate breast reconstruction using domestic AXM, Postmastectomy immediate breast reconstruction using synthetic mesh prostheses. |
| Immediate implant-based breast reconstructionAlso: Control group (synthetic mesh protstheses)Immediate breast reconstruction with a permanent implant, performed in the same operative session as mastectomy. | Procedure or surgery | Postmastectomy immediate breast reconstruction using domestic AXM, Postmastectomy immediate breast reconstruction using synthetic mesh prostheses. |
| Acellular xenogeneic matrix (AXM)Domestically produced acellular xenogeneic matrix used for implant coverage and soft tissue support during immediate breast reconstruction. | Device | Postmastectomy immediate breast reconstruction using domestic AXM |
| Synthetic mesh prosthesisSynthetic mesh prosthesis used for implant coverage and soft tissue support during immediate breast reconstruction. | Device | Postmastectomy immediate breast reconstruction using synthetic mesh prostheses. |
Primary outcome
Incidence of postoperative complications
Time frame: 1, 3, 6, 12 and 24 months after surgery
Proportion of participants with at least one postoperative complication after immediate implant-based breast reconstruction using acellular xenogeneic matrix or synthetic mesh prosthesis. Complications include surgical site infection, seroma, haematoma, skin or nipple-areola necrosis, wound dehiscence, implant exposure, capsular contracture and implant loss, graded according to the Clavien-Dindo classification.
2 secondary outcomes
Pain intensity measured by the Visual Analogue Scale (VAS)
Time frame: Postoperative day 3, day 7 and day 14
Health-related quality of life measured by the 36-Item Short Form Health Survey (SF-36)
Time frame: 1, 3, 6, 12 and 24 months after surgery
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 28 Aug 2026.
- Results publication: PubMed 36755646Choi YS, You HJ, Lee TY, Kim DW. Comparing Complications of Biologic and Synthetic Mesh in Breast Reconstruction: A Systematic Review and Network Meta-Analysis. Arch Plast Surg. 2023 Feb 6;50(1):3-9. doi: 10.1055/a-1964-8181. eCollection 2023 Jan.
- Results publicationColwell AS. One- and two-stage prosthetic reconstruction in nipple-sparing mastectomy. In: Plastic Surgery. 4th ed. Vol. 5. Elsevier; 2018:233-246.
- Individual participant dataSharing planned: No
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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.
Baurzhan Anapiya principal investigator
Baurzhan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical mastectomy with axillary lymph node dissection, Immediate implant-based breast reconstruction and Acellular xenogeneic matrix (AXM) in people with Brest Cancer, run by National Research Oncology and Transplantology Center, Kazakhstan at 1 site in Kazakhstan.
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 8 inclusion and 14 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 28 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 Kazakhstan. 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?
Incidence of postoperative complications (time frame: 1, 3, 6, 12 and 24 months after surgery). 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 NCT07782801, which also lists 2 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 28 Aug 2026.