- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091958
Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.
Reconstruction of Partial Mastectomy Defects With Myo-glandular Local Flap: Pilot Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Osama Hussein, MD, PhD
- Phone Number: +20 1099 8151 10
- Email: osamahussein@mans.edu.eg
Study Locations
-
-
DK
-
Mansourah, DK, Egypt, 35516
- Recruiting
- Mansoura University Oncology Center
-
Contact:
- Osama Hussein, MD,PhD,FEBS
- Phone Number: +2010 9981 5110
- Email: osamahussein@mans.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient refusal.
Contraindication of breast conservative therapy:
- Pregnancy.
- Diffuse microcalcifications.
- Patient choice for mastectomy.
- Collagen / vascular disease.
- Multicentric tumor.
- Psychological co-morbidity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post-tumourectomy reconstruction with myo-glandular flap.
Standard tumourectomy followed by reconstruction with myo-glandular flap.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of major complications
Time Frame: Six weeks after surgery.
|
The rate of major complications related to surgery that necessitate further intervention.
|
Six weeks after surgery.
|
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.
|
Six weeks after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The score of late cosmetic outcome
Time Frame: 12 Months 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.
|
12 Months after surgery.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of adequate resection
Time Frame: Two weeks after surgery.
|
This variable is dichotomous.
Histopathological examination of the paraffin blocks of the resected tumour specimen will be used to describe the resection safety margin.
The safety margin will be scored as either adequate or inadequate.
Adequate safety margin indicates no tumor on inked surface of the resected specimen.
Inadequate safety margin indicates presence of tumour on inked surface of the resected specimen.
|
Two weeks after surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Osama Hussein, MD,PhD.FEBS, Mansoura University
Publications and helpful links
General Publications
- Fisher 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.
- 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.
- Tobin 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R/19.08.578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on Pectoralis myo-glandular flap reconstruction.
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingBreast Cancer | Oncoplastic Breast Surgery | Aesthetic OutcomesChina
-
Chang Gung Memorial HospitalCompletedHead and Neck Cancer | Reconstructive SurgeryTaiwan
-
Vejle HospitalUniversity of Southern Denmark; Sygehus Lillebaelt; Region of Southern DenmarkCompletedBreast ReconstructionDenmark, Norway
-
University of ManitobaKeeping Abreast CharityCompletedDIEP Flap Breast Reconstruction | SIEA Flap Breast ReconstructionCanada
-
Taipei Medical University WanFang HospitalCompleted
-
St Vincent's University Hospital, IrelandPelvExCompletedRectal Cancer | Pelvic Cancer | Flap Necrosis | Flap Disorder | Perioperative Complication | Flap IschemiaIreland
-
University Hospital Southampton NHS Foundation...The Leeds Teaching Hospitals NHS Trust; University of Southampton; Newcastle-upon-Tyne... and other collaboratorsRecruitingQuality of Life | Surgery--Complications | Abdominal Cancer | Pelvic CancerUnited Kingdom
-
University Hospital, ToulouseTerminated
-
The National Institute of LymphologyThe DrMarga Practice Group; The Center for Restorative Breast Surgery, LLCUnknownBreast Cancer | Hereditary Breast/Ovarian Cancer (brca1, brca2) | Congenital Lymphedema | Acquired LymphedemaUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingBreast NeoplasmsChina