This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
382
The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.
Brigham and Women's Hospital Harvard Medical School
Boston, Massachusetts, United States
Change in BREAST-Q scale
compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).
Time frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
Change in EQ-5D-5L questionnaire
The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
loss of expander or implant
compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of loss of expander or implant. Loss of expander or implant is defined as an unplanned surgical removal of expander/implant with or without immediate replacement.
Time frame: within 24 months of undergoing mastectomy and immediate reconstruction
surgical complications
compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of surgical complications. The complications include: Wound dehiscence, Haematoma, Seroma, Implant/expander exposure/Extrusion, Implant/Expander rotation/malpositioning, Infection, Mastectomy skin flap necrosis, Capsular contraction, Lymphedema
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Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg, Austria
Medizinische Universität Wien
Vienna, Austria
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
Duisburg, Germany
KEM | Evang. Kliniken Essen-Mitte
Essen, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Landesfrauenklinik, Senologie und Brustzentrum
Wuppertal, Germany
National Institute of Oncology
Budapest, Hungary
Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica
Roma, Italy
Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center
Trento, Italy
...and 12 more locations
Time frame: within 24 months of undergoing mastectomy and immediate reconstruction
thromboembolic events
compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of thromboembolic events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: within 24 months of undergoing mastectomy and immediate reconstruction
patient satisfaction
compare patient satisfaction after pre-pectoral or sub-pectoral IBBR
Time frame: over 24 months since mastectomy
animation deformity
compare animation deformity after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy
Time frame: before and 24 months after the mastectomy
capsular contracture
compare capsular contracture after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy
Time frame: before and 24 months after the mastectomy
aesthetic results
compare aesthetic results after pre-pectoral or sub-pectoral IBBR assessed by photographs of the breast taken in a standardized way. They will be evaluated by an experienced investigator who is blinded for group assignment. The blinded outcome assessment team will be trained to enter data for the two most widely used semi-automatic software for objective aesthetic evaluation, the 'Breast Cancer Conservative Treatment cosmetic results' (BCCT.core)
Time frame: before and 24 months after the mastectomy
Recurrence-free survival (RFS)
RFS is defined as the time from randomization until the first documentation of any of the following events: local-regional occurrence or recurrence of invasive disease or ductal carcinoma in situ (DCIS), distant breast cancer metastasis, or death from any cause.
Time frame: until 10 years after mastectomy and IBBR.
aesthetic results evaluated by patients
evaluated by patients using a four point scale: excellent, good, regular, bad.
Time frame: at baseline and after 24 months
total number of operative procedures
assess the burden on patients by total number of operative procedures
Time frame: until 24 months after mastectomy
length of hospital stay (index hospitalization and overall)
length of hospital stay (index hospitalization and overall) following randomization until discharge and the cumulative number of days the patient was hospitalized
Time frame: until 24 months after randomization
total number of outpatient visits at the trial site and the emergency department
assess the burden on patients by total number of outpatient visits at the trial site and the emergency department
Time frame: from admission for mastectomy until 24 months after randomization
aesthetic results evaluated by local physicians
evaluated by local physicians using a four point scale: excellent, good, regular, bad.
Time frame: at baseline and after 24 months