Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC (NCT04293146)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (3 items).
Location: Brigham and Women's Hospital Harvard Medical School — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- No indication for IBBR according to clinical judgment of the treating surgeon
- Skin flaps inadequate for pre-pectoral IBBR.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (22 Sites)
- Brigham and Women's Hospital Harvard Medical School — Boston, Massachusetts
- Universitätsklinik für Frauenheilkunde und Geburtshilfe — Salzburg,
- Medizinische Universität Wien — Vienna,
- Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie — Duisburg,
- KEM | Evang. Kliniken Essen-Mitte — Essen,
- Universitätsklinikum Heidelberg — Heidelberg,
- Landesfrauenklinik, Senologie und Brustzentrum — Wuppertal,
- National Institute of Oncology — Budapest,
- Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica — Roma,
- Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center — Trento,
- Capio S:t Görans Hospital — Stockholm,
- Södersjukhuset — Stockholm,
- Karolinska University Hospital — Stockholm,
- Klinik Hirslanden Brustzentrum Aarau — Aarau,
- Kantonsspital Aarau AG — Aarau,
- University Hospital Basel, Division of Breast Surgery — Basel,
- Universitätsklinik für Plastische- und Handchirurgie, Inselspital — Bern,
- Lindenhof Bern — Bern,
- Kantonsspital Frauenfeld — Frauenfeld,
- Gesundheitszentrum Fricktal — Rheinfelden,
- Ospedale Regionale di Lugano — Viganello,
- Brust-Zentrum Zürich — Zurich,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.