Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

372

Study ID:

NCT04293146

Recruitment Status:

Recruiting

Sponsor:

University Hospital, Basel, Switzerland

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There are 20 Locations for this study

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Brigham and Women's Hospital Harvard Medical School
Boston Massachusetts, 02115, United States More Info
Yoon Chun, Dr. med
Contact
617-983-4774
[email protected]
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg , 5020, Austria More Info
Roland Reitsamer, Prof. Dr. med
Contact
+43 5 7255 27302
[email protected]
Medizinische Universität Wien
Wien , 1090, Austria More Info
Florian Fitzal, Prof. Dr. med
Contact
+43 1 40400 56460
[email protected]
Ruijin Hospital
Shanghai , 20002, China More Info
Xiasong Chen, Prof. Dr. med
Contact
[email protected]
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
Duisburg , , Germany More Info
Katja Engellandt, Dr. med.
Contact
+49 203 6008 3270
[email protected]
Katja Engellandt, Dr. med.
Principal Investigator
KEM | Evang. Kliniken Essen-Mitte
Essen , 45136, Germany More Info
Sherko Kümmel, Prof. Dr. med
Contact
+49 201 174 33002
[email protected]
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany More Info
Jörg Heil, Prof. Dr. med
Contact
+49 6221 56 7901
[email protected]
Landesfrauenklinik, Senologie und Brustzentrum
Wuppertal , , Germany More Info
Vesna Bjelic-Radisic, Prof. Dr. med.
Contact
+49 202 896-1401
[email protected]
Vesna Bjelic-Radisic, Prof. Dr. med.
Principal Investigator
National Institute of Oncology
Budapest , 1122, Hungary More Info
Zoltán Mátrai, Prof. Dr. med
Contact
+36 70 550 1268
[email protected]
Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica
Roma , , Italy More Info
Gianluca Franceschini, Prof. Dr. med.
Contact
+39 3201803270
[email protected]
Gianluca Franceschini, Prof. Dr. med.
Principal Investigator
Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center
Trento , , Italy More Info
Carlos A. Garcia-Etienne, Dr. med.
Contact
+39 0461902647
[email protected]
Carlos A. Garcia-Etienne, Dr. med.
Principal Investigator
Capio S:t Görans Hospital
Stockholm , 11281, Sweden More Info
Jana de Boniface, Prof. Dr. med
Contact
[email protected]
Södersjukhuset
Stockholm , 11281, Sweden More Info
Linda Nigard
Contact
[email protected]
Karolinska University Hospital
Stockholm , 17176, Sweden More Info
Amelia Chiorescu, Dr. med
Contact
+46 702437309
[email protected]
Klinik Hirslanden Brustzentrum Aarau
Aarau , 5000, Switzerland More Info
Ilario Fulco, Dr. med
Contact
+41 62 822 00 72
[email protected]
Kantonsspital Aarau AG
Aarau , 5001, Switzerland More Info
Dimitri Sarlos, PD Dr. med
Contact
+41 62 838 50 65
[email protected]
University Hospital Basel, Division of Breast Surgery
Basel , 4031, Switzerland More Info
Walter Weber, Prof. Dr. med
Contact
+41 61 328 61 49
[email protected]
Martin Haug, Prof. Dr. med
Contact
+41 61 265 7195
[email protected]
Universitätsklinik für Plastische- und Handchirurgie, Inselspital
Bern , 3010, Switzerland More Info
Mihai Constantinescu, Prof. Dr. med
Contact
+41 31 632 8014
[email protected]
Lindenhof Bern
Bern , 3011, Switzerland More Info
Thomas Fischer, Dr. med
Contact
+41 31 3115822
[email protected]
Kantonsspital Frauenfeld
Frauenfeld , 8501, Switzerland More Info
Thomas Holzbach, PD Dr. med
Contact
+41 52 723 76 76
[email protected]
Hirslanden Klinik St. Anna
Luzern , 6006, Switzerland
Gesundheitszentrum Fricktal
Rheinfelden , 4310, Switzerland More Info
Maik Hauschild, Dr. med.
Contact
+41 61 835 62 20
[email protected]
Kantonsspital St.Gallen
St Gallen , 9007, Switzerland
Ospedale Regionale di Lugano
Viganello , 6962, Switzerland More Info
Yves Harder, Prof. Dr. med
Contact
+41 91 811 75 47
[email protected]
Brust-Zentrum Zürich
Zürich , 8008, Switzerland More Info
Christoph Tausch, PD Dr. med
Contact
+41 44 533 81 00
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

372

Study ID:

NCT04293146

Recruitment Status:

Recruiting

Sponsor:


University Hospital, Basel, Switzerland

How clear is this clinincal trial information?

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