BRCA1/2 MutationPROFASNCT05391763
Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?
A study testing Fascia pectoralis preservation in people with BRCA1/2 Mutation and Bilateral Prophylactic Mastectomy, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- BRCA1/2 Mutation, Bilateral Prophylactic Mastectomy, Seroma
- What is being tested?
- Fascia pectoralis preservation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient
- Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam
- Ability to give written consent
- Adequate understanding of Dutch language
Who cannot join
- History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- Other malignancies
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Linetta Koppert, MD, PhD, MHS, +31107040151, l.koppert@erasmusmc.nl
Linetta Koppert, MD, PhD, MHS
About this study
Official title: Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?: Protocol of a Dutch Double Blinded, Prospective, Randomized Controlled Pilot Study With a Within-subject Design
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.
Read the detailed description
The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications.
The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF
The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.
- Being tested
- Fascia pectoralis preservation
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia pectoralis preservationProcedure or surgery
A total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery.
| Study group | Role | What they receive |
|---|---|---|
| Right: removal of fascia pectoralis, left: preservation of fascia pectoralis | Other | Not described Receives: Procedure: Fascia pectoralis preservation |
| Left: removal of fascia pectoralis, right: preservation of fascia pectoralis | Other | Not described Receives: Procedure: Fascia pectoralis preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainproduction in milliliters
The total drainage volume of the left and right breast in milliliters
Measured: Until drain removal, maximum 1 week
Time to drain removal in days
Number of days until drain removed
Measured: Until drain removal, maximum 1 week
Secondary outcomes (6)
Seroma (yes/no)
Occurrence of seroma
Measured: Up to 6 weeks
Needle aspirations (number)
Number of needle aspirations
Measured: Up to 6 weeks
Postoperative pain (score 1-10)
Postoperative pain measured with Visual Analogue Scale
Measured: Up to 6 weeks
Postoperative bleeding (yes/no)
Occurrence of postoperative bleeding
Measured: Up to 6 weeks
Wound related issues (yes/no)
Wound related issues such as hematoma or infection
Measured: Up to 6 weeks
Hospitalization duration (in days)
Duration of hospitalization, including readmissions
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (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 BRCA1/2 MutationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linetta Koppert, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391763
- Sponsor's protocol ID
- NL72939.078.20
- Other IDs
- NTR7620
- Acronym
- PROFAS
- Status last verified
- Jan 2023
- First submitted
- 17 May 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clarijs ME, van Egdom LSE, Verhoef C, Vasilic D, Koppert LB; PROFAS Collaborator Group. Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject design (PROFAS). BMJ Open. 2023 Feb 17;13(2):e066728. doi: 10.1136/bmjopen-2022-066728.
PubMed 36806067
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?: Protocol of a Dutch Double Blinded, Prospective, Randomized Controlled Pilot Study With a Within-subject Design
- ClinicalTrials.gov ID
- NCT05391763
- Acronym / sponsor ID
- PROFAS / NL72939.078.20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 May 2022 (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.
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.
Detailed description
The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications.
The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF
The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right: removal of fascia pectoralis, left: preservation of fascia pectoralis | Other | Procedure: Fascia pectoralis preservation |
| Left: removal of fascia pectoralis, right: preservation of fascia pectoralis | Other | Procedure: Fascia pectoralis preservation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient
- Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam
- Ability to give written consent
- Adequate understanding of Dutch language
Key exclusion criteria (2 listed)
- History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- Other malignancies
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 |
|---|---|---|
| Fascia pectoralis preservationA total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery. | Procedure or surgery | Left: removal of fascia pectoralis, right: preservation of fascia pectoralis, Right: removal of fascia pectoralis, left: preservation of fascia pectoralis |
Primary outcome
Drainproduction in milliliters
Time frame: Until drain removal, maximum 1 week
The total drainage volume of the left and right breast in milliliters
Time to drain removal in days
Time frame: Until drain removal, maximum 1 week
Number of days until drain removed
6 secondary outcomes
Seroma (yes/no)
Time frame: Up to 6 weeks
Needle aspirations (number)
Time frame: Up to 6 weeks
Postoperative pain (score 1-10)
Time frame: Up to 6 weeks
Postoperative bleeding (yes/no)
Time frame: Up to 6 weeks
Wound related issues (yes/no)
Time frame: Up to 6 weeks
Hospitalization duration (in days)
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 36806067Clarijs ME, van Egdom LSE, Verhoef C, Vasilic D, Koppert LB; PROFAS Collaborator Group. Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject design (PROFAS). BMJ Open. 2023 Feb 17;13(2):e066728. doi: 10.1136/bmjopen-2022-066728.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia pectoralis preservation in people with BRCA1/2 Mutation and Bilateral Prophylactic Mastectomy, run by Erasmus Medical Center at 1 site 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marloes Clarijs, MD (+31 6 22035529, m.clarijs@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainproduction in milliliters (time frame: Until drain removal, maximum 1 week). The study lists 2 primary outcomes in all. 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 NCT05391763, 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 11 Jan 2023.