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

Not Applicable

Active, not recruiting

• Conditions: Breast Reconstruction; Implant-Based Breast Reconstruction (IBBR)
• Interventions: Procedure: pre-pectoral IBBR; Procedure: sub-pectoral IBBR

• Registration Number: NCT04293146
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Study Start: 2020-07-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-05
• Study Completion: 2033-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 382

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-pectoral IBBR	pre-pectoral IBBR	-
sub-pectoral IBBR	sub-pectoral IBBR	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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	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)
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
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.
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
aesthetic results evaluated by patients	at baseline and after 24 months	evaluated by patients using a four point scale: excellent, good, regular, bad.
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
patient satisfaction	over 24 months since mastectomy	compare patient satisfaction after pre-pectoral or sub-pectoral IBBR
total number of operative procedures	until 24 months after mastectomy	assess the burden on patients by total number of operative procedures
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.

Trial Locations

Locations (22)

Universitätsklinik für Frauenheilkunde und Geburtshilfe; 🇦🇹 Salzburg, Austria

Brust-Zentrum Zürich; 🇨🇭 Zürich, Switzerland

Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center; 🇮🇹 Trento, Italy

KEM | Evang. Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Brigham and Women's Hospital Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie; 🇩🇪 Duisburg, Germany

Landesfrauenklinik, Senologie und Brustzentrum; 🇩🇪 Wuppertal, Germany

Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica; 🇮🇹 Roma, Italy

National Institute of Oncology; 🇭🇺 Budapest, Hungary

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Capio S:t Görans Hospital; 🇸🇪 Stockholm, Sweden

Kantonsspital Aarau AG; 🇨🇭 Aarau, Switzerland

Universitätsklinik für Plastische- und Handchirurgie, Inselspital; 🇨🇭 Bern, Switzerland

University Hospital Basel, Division of Breast Surgery; 🇨🇭 Basel, Switzerland

Klinik Hirslanden Brustzentrum Aarau; 🇨🇭 Aarau, Switzerland

Lindenhof Bern; 🇨🇭 Bern, Switzerland

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Kantonsspital Frauenfeld; 🇨🇭 Frauenfeld, Switzerland

Gesundheitszentrum Fricktal; 🇨🇭 Rheinfelden, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Viganello, Switzerland