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Could cow tissue make breast reconstruction safer?

NCT ID NCT07782801

Disease control Sponsor: National Research Oncology and Transplantology Center, Kazakhstan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This trial is testing a new material made from cow tissue, called AXM, to support breast implants during reconstruction surgery after breast cancer removal. The goal is to see if AXM works as well as or better than synthetic mesh, with fewer complications. Women with early-stage breast cancer (stage I-II) who are having a mastectomy may participate. The study will compare complication rates, pain, and quality of life between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
decellularized bovine peritoneum matrix (AXM) used as an implant support in breast reconstruction
What this could lead to
If AXM works, it could offer a safer, more affordable option for breast reconstruction after mastectomy, reducing complications and improving quality of life for breast cancer patients.
What could go wrong
This is an early-stage trial with a small number of participants. The biological material may not perform as well as expected, and there are risks of complications like infection or implant rejection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brest cancer

Contacts and locations

Locations

  • National Research Oncology Centre

    Astana, 010000, Kazakhstan

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