Trial reportBreast (Edinburgh, Scotland)2022
Long term outcome data from the EORTC 75111-10114 ETF/BCG randomized phase II study: Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer, followed by T-DM1 after progression.
Trial report in Breast (Edinburgh, Scotland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Frailty and outcomes in adults undergoing systemic anticancer treatment: a systematic review and meta-analysis.Journal of the National Cancer Institute · 2025Pooled it
- Metronomic Chemotherapy in Breast Cancer: Unleashing the Potential of Combination Regimens.Cancer innovation · 2025Review
- Antibody-drug conjugates in elderly patients with breast cancer.Breast (Edinburgh, Scotland) · 2025Review
- Incidence of antibody-drug conjugate-related hepatotoxicity in breast cancer: a systematic review and meta-analysis.Therapeutic advances in drug safety · 2024Article
- Cardiac toxicity of HER-2 targeting antibody-drug conjugates: overview and clinical implications.Future oncology (London, England) · 2024Review
- A Comprehensive Review on the State of the Art of Breast Cancers in Italy.Current medicinal chemistry · 2024Review
- Metronomic chemotherapy in cancer treatment: new wine in an old bottle.Theranostics · 2024Review
- Real-World Experience of Metronomic Chemotherapy in Metastatic Breast Cancer: Results of a Retrospective Unicenter Study.Breast care (Basel, Switzerland) · 2023Article
- Chemotherapeutic and targeted drugs-induced immunogenic cell death in cancer models and antitumor therapy: An update review.Frontiers in pharmacology · 2023Review
- Protein Kinase Inhibitors as a New Target for Immune System Modulation and Brain Cancer Management.International journal of molecular sciences · 2022Review
- Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer.Oncology research and treatment · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOlder patients are at higher risk of chemotherapy-induced toxicity, raising interest in less toxic anti-HER2 regimens for older persons with HER2-positive (HER2+) metastatic breast cancer (MBC). PATIENTS AND
methodsThis phase II study randomized (1:1) patients with HER2+ MBC, aged 70+ or frail 60+, to first line chemotherapy with metronomic oral cyclophosphamide (M) + Trastuzumab (T) and Pertuzumab (P) or TP alone. T-DM1 was offered in case of progression.
resultsIn total, 39 and 41 patients were randomized to TP and TPM arm respectively. Median follow-up is 54.0 months. 24-month PFS was 18.7% (95% CI 8.2-32.4) and 28.7% (95% CI 15.8-43.0), respectively. A total of 49 (61.3%) patients died of whom 37 (75.5%) from disease progression; number of deaths per arm was 27 (69.2%) for TP and 22 (53.7%) for TPM. There was no significant difference in OS between the two arms (median OS TP vs TPM: 32.1 vs 37.5 months, p 0.25). Among the 40 patients who have started T-DM1 after disease progression on TP/TPM, PFS rate at 6 months after start of T-DM1 was 43.6% (95% CI: 27.7-58.5) and grade 3 or higher AE occurred in 18 pts (45%).
conclusionsMetronomic chemotherapy-based dual blockade (TPM), followed by T-DM1 after progression, provides an active and relatively well tolerated treatment option in an older/frail HER2+ MBC population, with a median survival of over 3 years. Nevertheless, the majority of this older/frail population died from breast cancer, highlighting the need for well tolerated and efficacious treatments in these patients.
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