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

Breast Reconstruction Clinical Trial

— OPBC-02PREPEC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04293146
• Other study ID #: 2020-00256; ch18Weber4
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: February 2033

Study information

• Verified date: June 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 382
• Est. completion date: February 2033
• Est. primary completion date: February 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reconstruction
• Implant-Based Breast Reconstruction (IBBR)

Intervention

Procedure:
• pre-pectoral IBBR
The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
• sub-pectoral IBBR
The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

Locations

Country	Name	City	State
Austria	Universitätsklinik für Frauenheilkunde und Geburtshilfe	Salzburg
Austria	Medizinische Universität Wien	Wien
Germany	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
Hungary	National Institute of Oncology	Budapest
Italy	Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica	Roma
Italy	Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center	Trento
Sweden	Capio S:t Görans Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm
Switzerland	Kantonsspital Aarau AG	Aarau
Switzerland	Klinik Hirslanden Brustzentrum Aarau	Aarau
Switzerland	University Hospital Basel, Division of Breast Surgery	Basel
Switzerland	Lindenhof Bern	Bern
Switzerland	Universitätsklinik für Plastische- und Handchirurgie, Inselspital	Bern
Switzerland	Kantonsspital Frauenfeld	Frauenfeld
Switzerland	Gesundheitszentrum Fricktal	Rheinfelden
Switzerland	Ospedale Regionale di Lugano	Viganello
Switzerland	Brust-Zentrum Zürich	Zürich
United States	Brigham and Women's Hospital Harvard Medical School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Hungary,  Italy,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
Primary	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'.	within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
Secondary	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.	within 24 months of undergoing mastectomy and immediate reconstruction
Secondary	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	within 24 months of undergoing mastectomy and immediate reconstruction
Secondary	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	within 24 months of undergoing mastectomy and immediate reconstruction
Secondary	patient satisfaction	compare patient satisfaction after pre-pectoral or sub-pectoral IBBR	over 24 months since mastectomy
Secondary	animation deformity	compare animation deformity after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy	before and 24 months after the mastectomy
Secondary	capsular contracture	compare capsular contracture after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy	before and 24 months after the mastectomy
Secondary	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)	before and 24 months after the mastectomy
Secondary	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.	until 10 years after mastectomy and IBBR.
Secondary	aesthetic results evaluated by patients	evaluated by patients using a four point scale: excellent, good, regular, bad.	at baseline and after 24 months
Secondary	total number of operative procedures	assess the burden on patients by total number of operative procedures	until 24 months after mastectomy
Secondary	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	until 24 months after randomization
Secondary	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	from admission for mastectomy until 24 months after randomization
Secondary	aesthetic results evaluated by local physicians	evaluated by local physicians using a four point scale: excellent, good, regular, bad.	at baseline and after 24 months