Breast Cancer Stage INCT06931548
Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery
A study testing Implant-based breast reconstruction using polytetrafluoroethylene mesh and Implant-based breast reconstruction using Allogeneic dura mater graft in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Branch Office of "Hadassah Medical Ltd" at 1 site in Russia.
Trial summary
There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage II, In Situ Breast Cancer
- What is being tested?
- Implant-based breast reconstruction using polytetrafluoroethylene mesh and Implant-based breast reconstruction using Allogeneic dura mater graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2022to Feb 2026
- 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
- White women;
- Breast cancer stage 0-II;
- Indications for breast reconstruction;
- Consent to participate in the study and photographic documentation.
Who cannot join
- Non-white women;
- Breast cancer stage III-IV;
- Tubular breast;
- Mental and cognitive health disorders;
- Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);
- Patient refusal to participate in the study at any stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
The Branch of Hadassah Medical LTD
Moscow, Skolkovo Innovation Center, 121205
Igor Utyashev, PhD, +7 (495) 800-10-00 ext. 7041, i.utyashev@hadassah.moscow
About this study
Official title: Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft
There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control.
Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.
Read more
The primary questions this study aims to answer are:
- What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation.
- How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction?
- What is the patient satisfaction rate with the surgical results?
Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant.
After the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary.
Projections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques.
Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome.
The results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.
- Being tested
- Implant-based breast reconstruction using polytetrafluoroethylene mesh, Implant-based breast reconstruction using Allogeneic dura mater graft
- Keywords
- implant-based breast reconstruction, breast cancer, PTFE mesh
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant-based breast reconstruction using polytetrafluoroethylene meshProcedure or surgery
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with polytetrafluoroethylene (PTFE) mesh. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
Implant-based breast reconstruction using Allogeneic dura mater graftProcedure or surgery
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with an allogeneic dura mater graft. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
| Study group | Role | What they receive |
|---|---|---|
| Polytetrafluoroethylene mesh | Experimental | Patients in this group will undergo one-stage breast reconstruction using an implant and polytetrafluoroethylene (PTFE) mesh after subcutaneous or skin-sparing mastectomy. Receives: Procedure: Implant-based breast reconstruction using polytetrafluoroethylene mesh |
| Allogeneic dura mater graft | Active comparator | Patients in this group will undergo one-stage breast reconstruction using an implant and allogeneic dura mater graft after subcutaneous or skin-sparing mastectomy. Receives: Procedure: Implant-based breast reconstruction using Allogeneic dura mater graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major and minor complications
Major complications will be defined as complications that lead to revision surgery. These may include long-term seromas and hematomas, necrosis, infections that are not controlled by therapy or physical therapy. Also, displacement of the implant position by more than 2 cm.
Minor complications will be defined as complications that do not require reoperation.
Measured: within 6 months from the date of surgery
Secondary outcomes (2)
Evaluation of changes in projections of the implant and inframammary fold
After the operation and after 6 months, the following distances will be measured:
- from the jugular notch to the nipple;
- from the middle of the clavicle to the nipple;
- from the anterior midline to the nipple;
- from the inframammary fold to the nipple.
Calipers are used for measurements, distances are measured in the metric system. These measurements will allow you to assess the change in the position of the implant and, as a result, the shape of the breast. Changes in distances immediately after surgery and the same distances after 6 months by more than 1 cm (0.39 inches) will be considered a significant displacement of the implant.
Measured: within 6 months from the date of surgery
Quality of life
After surgery and 6 months later, patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire:
- "Physical well-being: chest";
- "Sexual well-being";
- "Psychosocial well-being";
- "Satisfaction with breast".
The BREAST-Q© is a rigorously developed patient-reported outcome (PRO) measure designed to evaluate outcomes among women undergoing different types of breast surgery. In this study, the "Reconstructive Module" of the questionnaire will be used.
There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL (depending on the scale).
Measured: within 6 months from the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Mar 2022
- Primary completionAug 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Branch Office of "Hadassah Medical Ltd"
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Responsible party
- Sponsor
- Investigators
- Alla Kartasheva, PhD, Principal investigator, The Branch of Hadassah Medical LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931548
- Sponsor's protocol ID
- BREAST-ONE
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie the results in a publication will be formed into a single tabular data array and placed in cloud storage. Access to viewing this array will be provided upon request of researchers or scientific publications (through the corresponding author).
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery Using Polytetrafluoroethylene (PTFE) Mesh or Allogeneic Dura Mater Graft
- ClinicalTrials.gov ID
- NCT06931548
- Acronym / sponsor ID
- BREAST-ONE
- Keywords
- implant-based breast reconstruction, breast cancer, PTFE mesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Branch Office of "Hadassah Medical Ltd"University, hospital or other
- Collaborators
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 17 Apr 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.
There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control.
Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.
The primary questions this study aims to answer are:
- What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation.
- How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction?
- What is the patient satisfaction rate with the surgical results?
Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant.
After the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary.
Projections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques.
Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome.
The results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polytetrafluoroethylene mesh | Experimental | Procedure: Implant-based breast reconstruction using polytetrafluoroethylene meshPatients in this group will undergo one-stage breast reconstruction using an implant and polytetrafluoroethylene (PTFE) mesh after subcutaneous or skin-sparing mastectomy. |
| Allogeneic dura mater graft | Active comparator | Procedure: Implant-based breast reconstruction using Allogeneic dura mater graftPatients in this group will undergo one-stage breast reconstruction using an implant and allogeneic dura mater graft after subcutaneous or skin-sparing mastectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- White women;
- Breast cancer stage 0-II;
- Indications for breast reconstruction;
- Consent to participate in the study and photographic documentation.
Key exclusion criteria (6 listed)
- Non-white women;
- Breast cancer stage III-IV;
- Tubular breast;
- Mental and cognitive health disorders;
- Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);
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 |
|---|---|---|
| Implant-based breast reconstruction using polytetrafluoroethylene meshPatients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with polytetrafluoroethylene (PTFE) mesh. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle. | Procedure or surgery | Polytetrafluoroethylene mesh |
| Implant-based breast reconstruction using Allogeneic dura mater graftPatients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with an allogeneic dura mater graft. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle. | Procedure or surgery | Allogeneic dura mater graft |
Primary outcome
Incidence of major and minor complications
Time frame: within 6 months from the date of surgery
Major complications will be defined as complications that lead to revision surgery. These may include long-term seromas and hematomas, necrosis, infections that are not controlled by therapy or physical therapy. Also, displacement of the implant position by more than 2 cm. Minor complications will be defined as complications that do not require reoperation.
2 secondary outcomes
Evaluation of changes in projections of the implant and inframammary fold
Time frame: within 6 months from the date of surgery
Quality of life
Time frame: within 6 months from the date of 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 17 Apr 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie the results in a publication will be formed into a single tabular data array and placed in cloud storage. Access to viewing this array will be provided upon request of researchers or scientific publications (through the corresponding author).
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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.
Alla Kartasheva, PhD principal investigator
The Branch of Hadassah Medical LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant-based breast reconstruction using polytetrafluoroethylene mesh and Implant-based breast reconstruction using Allogeneic dura mater graft in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Branch Office of "Hadassah Medical Ltd" at 1 site in Russia.
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 4 inclusion and 6 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 17 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 Russia. 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 Artem Mishin, MD (+7 (910) 175-98-75, dr.mishin@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major and minor complications (time frame: within 6 months from the date of surgery). 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 17 Apr 2025.