Breast CancerBREAST-IINCT04261829
AFT: Introduction of a Full Breast Reconstructive Method
An observational study of Breast Cancer and Reconstructive Surgery, run by Maastricht University Medical Center at 8 sites in Netherlands.
Trial summary
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Reconstructive Surgery, Breast Reconstruction
- What is being tested?
- Autologous Fat Transfer
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 8 sitesNetherlands
- Study dates
- 9 Dec 2020to Oct 2026
- Phase
- Observational
- 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
Study population: Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.
Who may be able to join
- Female gender
- Age of 18 years and older
- History or in candidate for a mastectomy procedure in the near future
- Patients undergoing preventive mastectomy
- Patients' choice to undergo a breast reconstruction
- Wanting to participate in this study
- Patient is able to wear the external expansion device
Who cannot join
- Active smoker or a history of smoking 4 weeks prior to surgery
- Current substance abuse
- History of lidocaine allergy
- History of silicone allergy
- 4 weeks or less after chemotherapy
- History of radiation therapy in the breast region
Show all 15Show fewer
- Oncological treatment includes radiotherapy after mastectomy
- Kidney disease
- Steroid dependent asthma (daily or weekly) or other diseases
- Immune-suppressed or compromised disease
- Uncontrolled diabetes
- BMI>30
- Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
- Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
- The treating plastic surgeon has strong doubts on the patient's treatment compliance
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Enrolling by invitation
Amsterdam University Medical Center (VUMC)
Amsterdam
- Enrolling by invitation
Rijnstate
Arnhem
- Enrolling by invitation
Alexander Monro, Bilthoven
Bilthoven
- Enrolling by invitation
Amphia
Breda
- Recruiting
Ziekenhuis groep Twente (ZGT)
Hengelo
Ute Schmidbauer, MD, MsC
- Recruiting
Medical Center Leeuwarden
Leeuwarden
Chantal Mouës, MD, MsC
- Enrolling by invitation
Maastricht University Medical Center+
Maastricht, Limburg, 6229 HX
- Recruiting
Viecuri Venlo
Venlo, Limburg
An Deliaert, MD, MsC
About this study
Official title: Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.
- Conditions
- Breast Cancer, Reconstructive Surgery, Breast Reconstruction
- Being tested
- Autologous Fat Transfer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat TransferProcedure or surgery
Also called Lipofilling
Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fat Transfer | Not described Receives: Procedure: Autologous Fat Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast-related Quality of life
Measured by the BREAST-Q questionnaire (quality of life subdivision)
Measured: 2 years
Secondary outcomes (4)
Aesthetic result
The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions).
Measured: 2 years
Complications
Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.
Measured: 2 years
Oncological safety
Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded.
Measured: 5 years
Cost-effectiveness
Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start9 Dec 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Andrzej Piatkowski de Grzymala, MD, MSc, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261829
- Sponsor's protocol ID
- NL72808.068.20
- Acronym
- BREAST-II
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rijkx M, Saelmans A, Hommes J, Brandts L, De Bruijn D, Piatkowski A, Heuts E; Breast Reconstruction With External Preexpansion & autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer. Ann Plast Surg. 2024 Oct 1;93(4):516-526. doi: 10.1097/SAP.0000000000004036. Epub 2024 Jul 15.
PubMed 39016317
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
- ClinicalTrials.gov ID
- NCT04261829
- Acronym / sponsor ID
- BREAST-II / NL72808.068.20
- Conditions
- Breast Cancer, Reconstructive Surgery, Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 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.
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Fat Transfer | – | Procedure: Autologous Fat Transfer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.
Key inclusion criteria (7 listed)
- Female gender
- Age of 18 years and older
- History or in candidate for a mastectomy procedure in the near future
- Patients undergoing preventive mastectomy
- Patients' choice to undergo a breast reconstruction
Key exclusion criteria (15 listed)
- Active smoker or a history of smoking 4 weeks prior to surgery
- Current substance abuse
- History of lidocaine allergy
- History of silicone allergy
- 4 weeks or less after chemotherapy
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 |
|---|---|---|
| Autologous Fat TransferAlso: LipofillingFemale breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion. | Procedure or surgery | Autologous Fat Transfer |
Primary outcome
Breast-related Quality of life
Time frame: 2 years
Measured by the BREAST-Q questionnaire (quality of life subdivision)
4 secondary outcomes
Aesthetic result
Time frame: 2 years
Complications
Time frame: 2 years
Oncological safety
Time frame: 5 years
Cost-effectiveness
Time frame: 2 years
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 29 Jul 2021.
- Derived from this study: PubMed 39016317Rijkx M, Saelmans A, Hommes J, Brandts L, De Bruijn D, Piatkowski A, Heuts E; Breast Reconstruction With External Preexpansion & autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer. Ann Plast Surg. 2024 Oct 1;93(4):516-526. doi: 10.1097/SAP.0000000000004036. Epub 2024 Jul 15.
- 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.
Andrzej Piatkowski de Grzymala, MD, MSc principal investigator
Maastricht University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Reconstructive Surgery, run by Maastricht University Medical Center at 8 sites in Netherlands.
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 7 inclusion and 15 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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 Jamilla Wederfoort, MD, MSc (0031-(0)43 387 2308, sander.schop@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast-related Quality of life (time frame: 2 years). 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 NCT04261829, 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 29 Jul 2021.