Summary of Research: HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination with Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer
This is a summary of a research article reporting the findings of the HER2CLIMB-05 trial (NCT05132582), a randomized, double-blind, placebo-controlled, international, phase III trial. The HER2CLIMB-05 trial was conducted to compare the efficacy and safety of adding tucatinib versus placebo to first-line maintenance therapy (trastuzumab and pertuzumab) following induction chemotherapy, in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. The key finding of the HER2CLIMB-05 trial was that progression-free survival was significantly improved in the tucatinib arm over the control arm (24.9 vs 16.3 months). The safety profile of tucatinib plus maintenance therapy was consistent with the known toxicities of each individual drug. The HER2CLIMB-05 regimen, with its high efficacy and manageable toxicity, represents a valuable option for first-line maintenance therapy in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer.
Authors
- Giuseppe Curigliano (ORCID: https://orcid.org/0000-0003-1781-2518)
- Eriko Tokunaga (ORCID: https://orcid.org/0000-0002-1640-5315)
- Junji Tsurutani (ORCID: https://orcid.org/0000-0002-6260-6943)
- Véronique Dièras (ORCID: https://orcid.org/0000-0001-8094-4738)
- G. Granata (ORCID: https://orcid.org/0000-0001-9651-4708)
- Marie-France Savard (ORCID: https://orcid.org/0000-0002-7651-0870)
- Shan Yang
- Qi Shen (ORCID: https://orcid.org/0000-0002-3132-5540)
- Xichun Hu (ORCID: https://orcid.org/0000-0002-9892-699X)
- Ciara C. O’Sullivan
- Volkmar Mueller
- Erika Hamilton
- Alicia Okines
- William Jacot
- Joohyuk Sohn
- Katarzyna J. Jerzak
- Miguel Martin
- Eduardo Cronemberger Silva
- the HER2CLIMB-05 Investigators
- Chiun-Sheng Huang
- Florence Lerebours
Institutions
- Sunnybrook Health Science Centre (CA)
- Royal Marsden NHS Foundation Trust (GB)
- Institute of Cancer Research (GB)
- Inserm (FR)
- Universität Hamburg (DE)
- Pfizer (United States) (US)
- University of Toronto (CA)
- University of Milan (IT)
- Université de Montpellier (FR)
- Ottawa Hospital (CA)
- Hospital General Universitario Gregorio Marañón (ES)
- Fudan University Shanghai Cancer Center (CN)
- National Hospital Organization Kyushu Cancer Center (JP)
- Sarah Cannon (US)
- University Medical Center Hamburg-Eppendorf (DE)
- Centre Eugène Marquis (FR)
- Mayo Clinic in Arizona (US)
- National Taiwan University Hospital (TW)
- Institut de Recherche en Cancérologie de Montpellier (FR)
- Regional Medical Center (US)
- SHOWA Medical University Hospital (JP)
- Yonsei University Health System (KR)
- European Institute of Oncology (IT)
- Institut Curie (FR)
Publication Details
- Journal
- Targeted Oncology
- Published
- 2026-09-19
- DOI
- https://doi.org/10.1007/s11523-026-01245-w
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00