ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019
Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 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
50 citing papers in PubMed, 80 citations in OpenAlex.
- NSABP FB-10: a phase Ib/II trial evaluating ado-trastuzumab emtansine (T-DM1) with neratinib in women with metastatic HER2-positive breast cancer.Breast cancer research : BCR · 2024Trial
- Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Lessons from a National Liquid Biopsy Program to Provide Cancer Testing and Treatment for Patients with Advanced Solid Tumors.Current oncology (Toronto, Ont.) · 2025Article
- Antibody-drug conjugates in breast cancer: mechanisms of resistance and future therapeutic perspectives.NPJ breast cancer · 2025Review
- Drug treatment of breast cancer brain metastases: progress and challenges.Discover oncology · 2025Review
- Modulation of HER2 internalization enhances single-dose antibody-drug potency in HER2Scientific reports · 2025Article
- Navigating the Landscape of Resistance Mechanisms in Antibody-Drug Conjugates for Cancer Treatment.Targeted oncology · 2025Review
- Spatially precise chemo-radio-immunotherapy by antibody drug conjugate directed tumor radiosensitization to potentiate immunotherapies.NPJ precision oncology · 2025Review
- Antibody-drug conjugates in breast cancer: current evidence and future directions.Experimental hematology & oncology · 2025Review
- Nonlinear progression during the occult transition establishes cancer lethality.Disease models & mechanisms · 2025Article
- Molecular mechanisms and therapeutic strategies in overcoming chemotherapy resistance in cancer.Molecular biomedicine · 2025Review
- Recent advances of antibody-drug conjugates in treating breast cancer with different HER2 status.Therapeutic advances in medical oncology · 2025Review
- Unveiling the future of breast cancer therapy: Cutting-edge antibody-drug conjugate strategies and clinical outcomes.Breast (Edinburgh, Scotland) · 2024Review
- Antibody-drug conjugates for breast cancer: a bibliometric study and clinical trial analysis.Discover oncology · 2024Article
- Quantitative systems pharmacology modeling of HER2-positive metastatic breast cancer for translational efficacy evaluation and combination assessment across therapeutic modalities.Acta pharmacologica Sinica · 2024Article
- Combined inhibition of HER2 and VEGFR synergistically improves therapeutic efficacy via PI3K-AKT pathway in advanced ovarian cancer.Journal of experimental & clinical cancer research : CR · 2024Article
- The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.Journal of hematology & oncology · 2024Review
- Case report: Near-complete response to neratinib-based treatment in HR-positiveFrontiers in oncology · 2024Article
- Antibody-drug conjugates combinations in cancer treatment.Exploration of targeted anti-tumor therapy · 2024Review
- Development of antibody-drug conjugates in cancer: Overview and prospects.Cancer communications (London, England) · 2024Review
Corrections and comments
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Authors and funding
18 authors at 8 institutions in 2 countries.
Funding
Abstract
purposePatients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer eventually develop resistance to dual-antibody therapy with trastuzumab plus pertuzumab. Mechanisms of resistance have not been well elucidated. We evaluated the safety, tolerability, and efficacy of ado-trastuzumab emtansine (T-DM1) plus neratinib in patients who progressed on trastuzumab plus pertuzumab. PATIENTS AND
methodsIn this 3 + 3 dose-escalation study, patients with metastatic breast cancer who progressed on trastuzumab, pertuzumab, and a taxane were treated with T-DM1 at 3.6 mg/kg intravenously every 3 weeks and dose-escalating neratinib at 120, 160, 200, or 240 mg/d orally.
resultsTwenty-seven patients were treated across four dose-levels of neratinib. Dose-limiting toxicity in cycle 1 was grade 3 diarrhea in six patients and grade 3 nausea in one; no patient experienced grade 4 diarrhea, and there were no grade 5 toxicities. Other grade 3 to 4 toxicities included nausea (11%), dehydration (11%), electrolyte abnormality (19%), thrombocytopenia (15%), elevated transaminase levels (7%), and fatigue (7%). Twelve (63%) of 19 evaluable patients had an objective response. Responses occurred at all neratinib doses. Plasma cell-free DNA at baseline showed
conclusionWe report the recommended phase II dose of T-DM1 3.6 mg/kg and neratinib 160 mg/d for this combination. Possible resistance mechanisms to HER2 antibodies may be loss of the HER2 receptor and high expression of p95HER2. These data provide the basis for an ongoing phase II study to better define the activity of this regimen.
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Registered trials
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.