Breast CancerPhase 1NCT04091958
Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.
A Phase 1 study testing Pectoralis myo-glandular flap reconstruction. in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pectoralis myo-glandular flap reconstruction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2019to 28 Feb 2022
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early breast cancer or phylloides tumor.
- Eligible for breast conservative surgery.
- Expected post-lumpectomy volume loss of 20-40% of breast volume.
- Tumor location in upper quadrants.
- Informed consent.
Who cannot join
- Patient refusal.
- Contraindication of breast conservative therapy:
- Pregnancy.
- Diffuse microcalcifications.
- Patient choice for mastectomy.
- Collagen / vascular disease.
- Multicentric tumor.
- Psychological co-morbidity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Oncology Center
Al Mansurah, DK, 35516
Osama Hussein, MD,PhD,FEBS, +2010 9981 5110, osamahussein@mans.edu.eg
About this study
Official title: Reconstruction of Partial Mastectomy Defects With Myo-glandular Local Flap: Pilot Study.
Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. The present study aims at improving the cosmetic outcome of breast conservative surgery. The defect remaining in the breast tissue after excision of the tumour will be filled with the underlying pectoralis major muscle. This pilot study will test the safety and efficacy of using the pectoralis major muscle for reconstructing a partial mastectomy defect. fifteen patients with early breast cancer scheduled for breast conservation will be recruited to this study.
Read the detailed description
Breast conservative surgery is the standard of care for early breast cancer patients. Large multi-center randomized trials have shown breast conservative surgery to be non-inferior to total mastectomy . Oncoplastic breast surgery consists of adequate tumorectomy followed by aesthetic repair of the partial mastectomy defect to achieve satisfactory cosmetic outcome. Oncoplastic surgery is recommended for all breast conservative operations. Level-I oncoplastic surgery is used to repair minor loss of breast volume. In this level, reconstruction is limited to mobilization and redistribution of the breast parenchyma to fill the tumorectomy defect. Larger volume loss requires complex procedures with significant morbidity and is called level-II oncoplasty. In level-II procedures, extra-mammary tissue is mobilized to fill the breast defect (volume replacement). Alternatively, bilateral reduction mammoplasty procedure (volume displacement) is used to reconfigure the breast, obliterate the tumorectomy defect and correct associated breast hypertrophy or ptosis. With either strategy, volume replacement and volume displacement require extensive skin incisions and tissue mobilization. Thus, level-II oncoplasty achieve maximum aesthetic outcome on the expense of major surgical trauma and significant probability of operative morbidity. Recent years have witnessed renewed interest in de-escalating oncoplastic surgical strategies. Level-I oncoplastic operations have been used more frequently to fulfil the cosmetic needs of the majority of breast conservative operations. Moreover, the patient acceptability of the complex level-II oncoplastic procedures is not universal. With the exception of level-II oncoplastic procedures, breast cancer surgery is a well-tolerated intervention that can be offered in a fast-track or day-case basis with economic, psychological and social advantages.
In view of the above-mentioned considerations, The investigators and others have worked to expand the role of level-I oncoplastic surgery. Several innovative techniques have been recommended to allow repair of wider post-tumorectomy defects with simple mobilization of breast parenchymal flaps.
The pectoralis major muscle flap is the classic workhorse of reconstructive surgery of the head and neck. The muscle has been extensively used as a pedicled or free flap to achieve reconstruction of major post-ablative tissue defects. In aesthetic breast surgery, pectoralis major muscle has been used as a sling to correct breast ptosis.
The investigators hypothesized that mobilization of glandular tissue based on underlying pectoralis major fibres will allow repair of larger defects using an "extended level-I oncoplasty". Pectoralis major is known to have reliable segmental blood supply that allows muscle-sparing flap construction with minimal or no functional deficit.
The aim of this work is to evaluate the operative and aesthetic outcome of extended-level-I oncoplastic reconstruction with pectoralis myo-parenchymal flaps.
This is a pilot study that is equivalent to a phase I trial i.e. a safety study. The primary goal is to identify unforeseen surgical, oncologic or cosmetic drawbacks for the technique. This study will also evaluate the efficacy of the technique for providing satisfactory cosmetic outcome.
- Conditions
- Breast Cancer
- Being tested
- Pectoralis myo-glandular flap reconstruction.
- Keywords
- Breast conserving surgery, Pectoralis major muscle
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoralis myo-glandular flap reconstruction.Procedure or surgery
Tumorectomy with surgical margin will be evaluated with frozen-section examination. Reconstruction starts with mobilization of skin flaps. The sternal head of the pectoralis major muscle will be disconnected from its insertion at the humerus. The muscle fibers will be mobilized off the chest wall. The pectoralis major receives dual blood supply. The pectoral branches of the thoraco-acromial artery enter the superior part of the muscle and the perforator branches of the internal mammary artery enter the medial part of the muscle. According to the location of the defect in the breast, the muscle will be mobilized based on one vascular pedicle. The muscle flap may consist of all or some segmental fibres of the sternal head of the pectoralis major muscle. In all cases, the muscle flap connection to the overlying breast parenchyma is kept intact and the clavicular head of the pectoralis major muscle is undisturbed. Closure of the cavity in layers over suction drain will follow.
| Study group | Role | What they receive |
|---|---|---|
| Post-tumourectomy reconstruction with myo-glandular flap. | Experimental | Standard tumourectomy followed by reconstruction with myo-glandular flap. Receives: Procedure: Pectoralis myo-glandular flap reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major complications
The rate of major complications related to surgery that necessitate further intervention.
Measured: Six weeks after surgery.
The score of early cosmetic outcome
This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.
Measured: Six weeks after surgery.
Secondary outcomes (1)
The score of late cosmetic outcome
This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.
Measured: 12 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 posted17 Sep 2019
- Study start24 Aug 2019
- Primary completion30 Jan 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a cohort study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hussein, Mansoura University
- Investigators
- Osama Hussein, MD,PhD.FEBS, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091958
- Sponsor's protocol ID
- R/19.08.578
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.
PubMed 110740Tobin GR. Pectoralis major segmental anatomy and segmentally split pectoralis major flaps. Plast Reconstr Surg. 1985 Jun;75(6):814-24. doi: 10.1097/00006534-198506000-00009.
PubMed 4001201Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Partial Mastectomy Defects With Myo-glandular Local Flap: Pilot Study.
- ClinicalTrials.gov ID
- NCT04091958
- Acronym / sponsor ID
- R/19.08.578
- Conditions
- Breast Cancer
- Keywords
- Breast conserving surgery, Pectoralis major muscle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Aug 2019 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 17 Sep 2019 (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.
Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. The present study aims at improving the cosmetic outcome of breast conservative surgery. The defect remaining in the breast tissue after excision of the tumour will be filled with the underlying pectoralis major muscle. This pilot study will test the safety and efficacy of using the pectoralis major muscle for reconstructing a partial mastectomy defect. fifteen patients with early breast cancer scheduled for breast conservation will be recruited to this study.
Detailed description
Breast conservative surgery is the standard of care for early breast cancer patients. Large multi-center randomized trials have shown breast conservative surgery to be non-inferior to total mastectomy . Oncoplastic breast surgery consists of adequate tumorectomy followed by aesthetic repair of the partial mastectomy defect to achieve satisfactory cosmetic outcome. Oncoplastic surgery is recommended for all breast conservative operations. Level-I oncoplastic surgery is used to repair minor loss of breast volume. In this level, reconstruction is limited to mobilization and redistribution of the breast parenchyma to fill the tumorectomy defect. Larger volume loss requires complex procedures with significant morbidity and is called level-II oncoplasty. In level-II procedures, extra-mammary tissue is mobilized to fill the breast defect (volume replacement). Alternatively, bilateral reduction mammoplasty procedure (volume displacement) is used to reconfigure the breast, obliterate the tumorectomy defect and correct associated breast hypertrophy or ptosis. With either strategy, volume replacement and volume displacement require extensive skin incisions and tissue mobilization. Thus, level-II oncoplasty achieve maximum aesthetic outcome on the expense of major surgical trauma and significant probability of operative morbidity. Recent years have witnessed renewed interest in de-escalating oncoplastic surgical strategies. Level-I oncoplastic operations have been used more frequently to fulfil the cosmetic needs of the majority of breast conservative operations. Moreover, the patient acceptability of the complex level-II oncoplastic procedures is not universal. With the exception of level-II oncoplastic procedures, breast cancer surgery is a well-tolerated intervention that can be offered in a fast-track or day-case basis with economic, psychological and social advantages.
In view of the above-mentioned considerations, The investigators and others have worked to expand the role of level-I oncoplastic surgery. Several innovative techniques have been recommended to allow repair of wider post-tumorectomy defects with simple mobilization of breast parenchymal flaps.
The pectoralis major muscle flap is the classic workhorse of reconstructive surgery of the head and neck. The muscle has been extensively used as a pedicled or free flap to achieve reconstruction of major post-ablative tissue defects. In aesthetic breast surgery, pectoralis major muscle has been used as a sling to correct breast ptosis.
The investigators hypothesized that mobilization of glandular tissue based on underlying pectoralis major fibres will allow repair of larger defects using an "extended level-I oncoplasty". Pectoralis major is known to have reliable segmental blood supply that allows muscle-sparing flap construction with minimal or no functional deficit.
The aim of this work is to evaluate the operative and aesthetic outcome of extended-level-I oncoplastic reconstruction with pectoralis myo-parenchymal flaps.
This is a pilot study that is equivalent to a phase I trial i.e. a safety study. The primary goal is to identify unforeseen surgical, oncologic or cosmetic drawbacks for the technique. This study will also evaluate the efficacy of the technique for providing satisfactory cosmetic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cohort study.
| Arm | Type | Receives |
|---|---|---|
| Post-tumourectomy reconstruction with myo-glandular flap. | Experimental | Procedure: Pectoralis myo-glandular flap reconstruction.Standard tumourectomy followed by reconstruction with myo-glandular flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with early breast cancer or phylloides tumor.
- Eligible for breast conservative surgery.
- Expected post-lumpectomy volume loss of 20-40% of breast volume.
- Tumor location in upper quadrants.
- Informed consent.
Key exclusion criteria (8 listed)
- Patient refusal.
- Contraindication of breast conservative therapy:
- Psychological co-morbidity.
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 |
|---|---|---|
| Pectoralis myo-glandular flap reconstruction.Tumorectomy with surgical margin will be evaluated with frozen-section examination. Reconstruction starts with mobilization of skin flaps. The sternal head of the pectoralis major muscle will be disconnected from its insertion at the humerus. The muscle fibers will be mobilized off the chest wall. The pectoralis major receives dual blood supply. The pectoral branches of the thoraco-acromial artery enter the superior part of the muscle and the perforator branches of the internal mammary artery enter the medial part of the muscle. According to the location of the defect in the breast, the muscle will be mobilized based on one vascular pedicle. The muscle flap may consist of all or some segmental fibres of the sternal head of the pectoralis major muscle. In all cases, the muscle flap connection to the overlying breast parenchyma is kept intact and the clavicular head of the pectoralis major muscle is undisturbed. Closure of the cavity in layers over suction drain will follow. | Procedure or surgery | Post-tumourectomy reconstruction with myo-glandular flap. |
Primary outcome
The rate of major complications
Time frame: Six weeks after surgery.
The rate of major complications related to surgery that necessitate further intervention.
The score of early cosmetic outcome
Time frame: Six weeks after surgery.
This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.
1 secondary outcome
The score of late cosmetic outcome
Time frame: 12 Months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 110740Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.
- Background: PubMed 4001201Tobin GR. Pectoralis major segmental anatomy and segmentally split pectoralis major flaps. Plast Reconstr Surg. 1985 Jun;75(6):814-24. doi: 10.1097/00006534-198506000-00009.
- Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
- 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. This study is not recruiting at the moment.
Osama Hussein, MD,PhD.FEBS principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pectoralis myo-glandular flap reconstruction. in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 8 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 19 Nov 2020. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Osama Hussein, MD, PhD (+20 1099 8151 10, osamahussein@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of major complications (time frame: Six weeks after surgery.). 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 NCT04091958, which also lists 3 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 19 Nov 2020.