Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04293146

Collaborator

Swiss National Science Foundation (Other)

372

Enrollment

Locations

Arms

151.1

Anticipated Duration (Months)

14.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction Implant-Based Breast Reconstruction (IBBR)	Procedure: pre-pectoral IBBR Procedure: sub-pectoral IBBR	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

372 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.

Masking:

Single (Outcomes Assessor)

Masking Description:

blinded outcome assessment for aesthetic results

Primary Purpose:

Other

Official Title:

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): A Pragmatic, Multicenter, Randomized, Superiority Trial

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

Mar 1, 2032

Anticipated Study Completion Date :

Mar 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: pre-pectoral IBBR	Procedure: pre-pectoral IBBR The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
Active Comparator: sub-pectoral IBBR	Procedure: sub-pectoral IBBR The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

Arm

Intervention/Treatment

Active Comparator: pre-pectoral IBBR

Procedure: pre-pectoral IBBR

The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.

Active Comparator: sub-pectoral IBBR

Procedure: sub-pectoral IBBR

The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

Outcome Measures

Primary Outcome Measures

Change in BREAST-Q scale [within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)]
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).
Change in EQ-5D-5L questionnaire [within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)]
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'.

Secondary Outcome Measures

loss of expander or implant [within 24 months of undergoing mastectomy and immediate reconstruction]
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.
surgical complications [within 24 months of undergoing mastectomy and immediate reconstruction]
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
thromboembolic events [within 24 months of undergoing mastectomy and immediate reconstruction]
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
patient satisfaction [over 24 months since mastectomy]
compare patient satisfaction after pre-pectoral or sub-pectoral IBBR
animation deformity [before and 24 months after the mastectomy]
compare animation deformity after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy
capsular contracture [before and 24 months after the mastectomy]
compare capsular contracture after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy
aesthetic results [before and 24 months after the mastectomy]
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)
Recurrence-free survival (RFS) [until 10 years after mastectomy and IBBR.]
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.
aesthetic results evaluated by patients [at baseline and after 24 months]
evaluated by patients using a four point scale: excellent, good, regular, bad.
total number of operative procedures [until 24 months after mastectomy]
assess the burden on patients by total number of operative procedures
length of hospital stay (index hospitalization and overall) [until 24 months after randomization]
length of hospital stay (index hospitalization and overall) following randomization until discharge and the cumulative number of days the patient was hospitalized
total number of outpatient visits at the trial site and the emergency department [from admission for mastectomy until 24 months after randomization]
assess the burden on patients by total number of outpatient visits at the trial site and the emergency department
aesthetic results evaluated by local physicians [at baseline and after 24 months]
evaluated by local physicians using a four point scale: excellent, good, regular, bad.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
Ability to complete the Quality of Life questionnaires

Exclusion Criteria:

No indication for IBBR according to clinical judgment of the treating surgeon
Skin flaps inadequate for pre-pectoral IBBR.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital Harvard Medical School	Boston	Massachusetts	United States	02115
2	Universitätsklinik für Frauenheilkunde und Geburtshilfe	Salzburg		Austria	5020
3	Medizinische Universität Wien	Wien		Austria	1090
4	Ruijin Hospital	Shanghai		China	200025
5	Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie	Duisburg		Germany
6	KEM \| Evang. Kliniken Essen-Mitte	Essen		Germany	45136
7	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
8	Landesfrauenklinik, Senologie und Brustzentrum	Wuppertal		Germany
9	National Institute of Oncology	Budapest		Hungary	1122
10	Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica	Roma		Italy
11	Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center	Trento		Italy
12	Capio S:t Görans Hospital	Stockholm		Sweden	11281
13	Södersjukhuset	Stockholm		Sweden	11281
14	Karolinska University Hospital	Stockholm		Sweden	17176
15	Klinik Hirslanden Brustzentrum Aarau	Aarau		Switzerland	5000
16	Kantonsspital Aarau AG	Aarau		Switzerland	5001
17	University Hospital Basel, Division of Breast Surgery	Basel		Switzerland	4031
18	Universitätsklinik für Plastische- und Handchirurgie, Inselspital	Bern		Switzerland	3010
19	Lindenhof Bern	Bern		Switzerland	3011
20	Kantonsspital Frauenfeld	Frauenfeld		Switzerland	8501
21	Hirslanden Klinik St. Anna	Luzern		Switzerland	6006
22	Gesundheitszentrum Fricktal	Rheinfelden		Switzerland	4310
23	Kantonsspital St.Gallen	St Gallen		Switzerland	9007
24	Ospedale Regionale di Lugano	Viganello		Switzerland	6962
25	Brust-Zentrum Zürich	Zürich		Switzerland	8008