Trial reportBreast cancer research : BCR2019
A phase I/II study of epertinib plus trastuzumab with or without chemotherapy in patients with HER2-positive metastatic breast cancer.
Trial report in Breast cancer research : BCR, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 64 citations in OpenAlex.
- Advances in Small-molecule Dual Inhibitors Targeting EGFR and HER2 Receptors as Anti-cancer Agents.Current medicinal chemistry · 2025Review
- Depicting Biomarkers for HER2-Inhibitor Resistance: Implication for Therapy in HER2-Positive Breast Cancer.Cancers · 2024Review
- Molecular Targeting of the Human Epidermal Growth Factor Receptor-2 (HER2) Genes across Various Cancers.International journal of molecular sciences · 2024Review
- Standard-of-Care Treatment for HER2+ Metastatic Breast Cancer and Emerging Therapeutic Options.Breast cancer : basic and clinical research · 2024Review
- Novel HER-2 Targeted Therapies in Breast Cancer.Cancers · 2023Review
- Unlocking New Avenues in Breast Cancer Treatment: The Synergy of Kinase Inhibitors and Immunotherapy.Cancers · 2023Review
- The History and Development of HER2 Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Review
- Targeting HER2-positive breast cancer: advances and future directions.Nature reviews. Drug discovery · 2023Review
- Refining Therapy in Patients with HER2-Positive Breast Cancer with Central Nervous System Metastasis.Breast care (Basel, Switzerland) · 2022Review
- Review
- Intracranial Response Rate in Patients with Breast Cancer Brain Metastases after Systemic Therapy.Cancers · 2022Review
- Efficacy and Risk Factors of Pyrrotinib in Second- and Third-Line Treatments for HER2-Positive Advanced Breast Cancer.Computational and mathematical methods in medicine · 2022Article
- Is Molecular Tailored-Therapy Changing the Paradigm for CNS Metastases in Breast Cancer?Clinical drug investigation · 2021Review
- HER2-positive breast cancer and tyrosine kinase inhibitors: the time is now.NPJ breast cancer · 2021Review
- Upregulation of microRNA-181a-5p increases the sensitivity of HS578T breast cancer cells to cisplatin by inducing vitamin D receptor-mediated cell autophagy.Oncology letters · 2021Article
- Comparison of pyrotinib or lapatinib with chemotherapy for patients with HER2 positive breast cancer after first-line treatment failure: a retrospective study.American journal of translational research · 2021Article
- Management of Brain and Leptomeningeal Metastases from Breast Cancer.International journal of molecular sciences · 2020Review
- Evolving treatment strategies of brain metastases from breast cancer: current status and future direction.Therapeutic advances in medical oncology · 2020Article
- HER2-targeted therapy prolongs survival in patients with HER2-positive breast cancer and intracranial metastatic disease: a systematic review and meta-analysis.Neuro-oncology advancesArticle
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 3 countries.
Funding
Abstract
backgroundEpertinib (S-222611) is a potent reversible inhibitor of HER2, EGFR and HER4. This trial evaluated the safety, tolerability, pharmacokinetics and antitumour activity of daily oral epertinib combined with trastuzumab (arm A), with trastuzumab plus vinorelbine (arm B) or with trastuzumab plus capecitabine (arm C), in patients with HER2-positive metastatic breast cancer (MBC).
methodsEligible patients, with or without brain metastases, had received prior HER2-directed therapy. A dose-escalation phase determined the tolerability of each combination and established a dose for further study. Further, patients were recruited to expansion cohorts in each of the 3 arms to further explore efficacy and safety.
resultsThe recommended doses of epertinib were 600 mg, 200 mg and 400 mg in arms A, B and C, respectively. The most frequent grade 3/4 adverse event (AE) was diarrhoea in all arms, which was manageable with medical intervention and dose modification. The objective response rate (complete response [CR] plus partial response [PR]) in heavily pre-treated HER2-positive MBC patients at the recommended doses of epertinib combined with trastuzumab was 67% (N = 9), with trastuzumab plus vinorelbine was 0% (N = 5) and with trastuzumab plus capecitabine was 56% (N = 9). Notably, 4 of 6 patients previously treated with T-DM1 responded in the arm A expansion cohort (epertinib plus trastuzumab). In the arm C expansion cohort (epertinib plus trastuzumab plus capecitabine), 4 of 7 patients responded despite previous exposure to capecitabine. Measurable regression of brain metastases was observed in patients with CNS target lesions treated in both arms A and C.
conclusionWe observed safety, tolerability and encouraging antitumour activity of epertinib combined with trastuzumab, or with trastuzumab plus capecitabine. This supports further evaluation of these combinations in patients with pre-treated HER2-positive MBC, with or without brain metastases.
trial registrationEudraCT Number: 2013-003894-87; registered 09-September-2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.