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.
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.
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.
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There are 20 Locations for this study
Boston Massachusetts, 02115, United States More Info
Duisburg , , Germany More Info
Principal Investigator
Wuppertal , , Germany More Info
Principal Investigator
Roma , , Italy More Info
Principal Investigator
Trento , , Italy More Info
Principal Investigator
Bern , 3010, Switzerland More Info
Luzern , 6006, Switzerland
St Gallen , 9007, Switzerland
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