Trial reportJCO precision oncology2021
Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells.
Trial report in JCO precision oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 13 citations in OpenAlex.
- Trastuzumab and first-line taxane chemotherapy in metastatic breast cancer patients with a HER2-negative tumor and HER2-positive circulating tumor cells: a phase II trial.Breast cancer research and treatment · 2024Trial
- Liquid biopsy in breast cancer: clinical implications of ctDNA and CTCs in diagnosis, treatment and monitoring.Molecular and cellular biochemistry · 2025Review
- Concordance of HER2 status between primary tumor and circulating tumor cells in breast cancer.Discover oncology · 2024Article
- Circulating tumor cells in breast cancer: clinical validity and utility.NPJ breast cancer · 2024Review
- Comparing the HER2 Status of the Primary Tumor to That of Disseminated Tumor Cells in Early Breast Cancer.International journal of molecular sciences · 2024Article
- Review
- Liquid biopsy for brain metastases and leptomeningeal disease in patients with breast cancer.NPJ breast cancer · 2023Review
- Utilization of Circulating Tumor Cells in the Management of Solid Tumors.Journal of personalized medicine · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
purposeHuman epidermal growth factor receptor 2 (HER2)-directed treatments improve outcomes for patients with HER2-positive metastatic breast cancer (MBC). Current identification of patients with HER2-positive disease relies on tumor tissue testing, which can be inaccurate because of tumor heterogeneity or tumor evolution. Circulating tumor cells (CTCs) are often present in patients with cancer. We hypothesized that HER2 assessment of CTCs in patients with HER2-negative breast cancer could identify a subset of patients with HER2-positive CTCs who could benefit from HER2-directed treatments.
methodsThis was a single-arm, two-stage, phase II trial. Patients with HER2-negative progressive MBC with HER2-positive CTC (defined as HER2/CEP17 ratio ≥ 2.0 by fluorescence in situ hybridization), ≥ 1 prior chemotherapy regimen for MBC, and no prior vinorelbine received trastuzumab in combination with vinorelbine on days 1, 8, and 15 of a 21-day cycle. The primary end point was objective response rate.
resultsFrom January 2013 to June 2014, we prospectively screened CTCs from patients with HER2-negative MBC. CTCs were detected in 201 of 311 patients (65%). The median number of CTCs was 10 (interquartile range, 3-57). Sixty-nine of 311 patients (22%) had HER2+ CTCs, with a median of three HER2+ CTCs (range 1-21). Twenty patients with HER2+ CTCs were treated on study. At data cutoff (January 13, 2017), no patients remained on study therapy. The objective response rate was 5% (95% CI, 0.1 to 24.9), with one of 20 patients experiencing a partial response. The clinical benefit rate was 20.0% (1 partial response and 3 stable diseases > 24 weeks, 95% CI, 5.7% to 43.7%). The median progression-free survival was 2.7 months.
conclusionCTC analysis of patients with HER2-negative MBC identifies a subset with HER2-amplified CTCs. However, clinical activity of an HER2-directed regimen in this population was low. The functional significance of HER2-positive CTCs remains uncertain.
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