Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC (NCT04293146)
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
🩺 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: Review the eligibility criteria below.
Location: Brigham and Women's Hospital Harvard Medical School — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
- pre-pectoral IBBR (PROCEDURE)
- sub-pectoral IBBR (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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.
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- Access My Breast Cancer Care App — Vancouver, British Columbia
- Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction — Boston, Massachusetts
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.