Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study
PH FDC SC was well tolerated, with safety consistent with that of P + H IV (except local injection-site reactions) and no grade ≥ 3 anaphylaxis/hypersensitivity or new safety signals in the continuation period. Immature efficacy data showed high event-free rates, consistent with the known clinical benefit of pertuzumab and trastuzumab (although follow-up was relatively short at 3 years). PHranceSCa adds to the totality of evidence reinforcing the long-term clinical benefit and safety of pertuzumab and trastuzumab.
Authors
- Thomas Boulet (ORCID: https://orcid.org/0000-0002-5577-4973)
- Susana Sousa (ORCID: https://orcid.org/0000-0003-0680-474X)
- Päivi Auvinen (ORCID: https://orcid.org/0000-0002-2392-9395)
- Nadia Theron
- Peter C. Trask
- Josefina Cruz Jurado (ORCID: https://orcid.org/0000-0001-6398-1641)
- Ljiljana Stamatović
- Joyce O’Shaughnessy (ORCID: https://orcid.org/0000-0002-2955-5523)
- Ana Cvetanović (ORCID: https://orcid.org/0000-0002-4113-9274)
- Mauricio Burotto (ORCID: https://orcid.org/0000-0002-7150-4033)
- Valentine Revelant (ORCID: https://orcid.org/0000-0001-8924-5976)
- Catarina Pulido (ORCID: https://orcid.org/0000-0002-4313-7213)
- Lesley Fallowfield (ORCID: https://orcid.org/0000-0003-0577-4518)
- Laurentia Wahyudi
- Z. Machackova
- Sharon Wilks (ORCID: https://orcid.org/0000-0003-2004-4273)
- Leonor Ribeiro (ORCID: https://orcid.org/0000-0002-7657-0902)
Institutions
- Brighton and Sussex Medical School (GB)
- Roche (Switzerland) (CH)
- University of Nis (RS)
- University of Sussex (GB)
- Texas Oncology (US)
- Hospital Universitario de Canarias (ES)
- Baylor University Medical Center (US)
- Kuopio University Hospital (FI)
- Oncology Institute of Vojvodina (RS)
- Administração Regional de Saúde de Lisboa e Vale do Tejo (PT)
- CUF Porto Hospital (PT)
- Hospital da Luz (PT)
- Hospital de Santa Maria (PT)
Publication Details
- Journal
- Clinical Breast Cancer
- Published
- 2025-05-03
- DOI
- https://doi.org/10.1016/j.clbc.2025.04.016
- Citations
- 2
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 2.09
Funders
- Roche
- F. Hoffmann-La Roche