Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008
A phase I-II study of combined blockade of the ErbB receptor network with trastuzumab and gefitinib in patients with HER2 (ErbB2)-overexpressing metastatic breast cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
40 citing papers in PubMed, 77 citations in OpenAlex.
- Trial
- A phase I/II prospective, single arm trial of gefitinib, trastuzumab, and docetaxel in patients with stage IV HER-2 positive metastatic breast cancer.Breast cancer research and treatment · 2012Trial
- A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach.Clinical breast cancer · 2009Trial
- Unveiling the Molecular Mechanism of Trastuzumab Resistance in SKBR3 and BT474 Cell Lines for HER2 Positive Breast Cancer.Current issues in molecular biology · 2024Article
- Structure-activity relationships of novel quinazoline derivatives with high selectivity for HER2 over EGFR.Archives of pharmacal research · 2022Article
- Evolving Evidence for the Optimization of Neoadjuvant Therapy in Triple-Negative Breast Cancer.Breast cancer : basic and clinical research · 2022Review
- Acquired resistance to third-generation EGFR-TKIs and emerging next-generation EGFR inhibitors.Innovation (Cambridge (Mass.)) · 2021Review
- Epithelial-Mesenchymal Transition Programs and Cancer Stem Cell Phenotypes: Mediators of Breast Cancer Therapy Resistance.Molecular cancer research : MCR · 2020Review
- Phase I trial of afatinib and 3-weekly trastuzumab with optimal anti-diarrheal management in patients with HER2-positive metastatic cancer.Cancer chemotherapy and pharmacology · 2018Article
- LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer.Cancer chemotherapy and pharmacology · 2017Article
- Combating HER2-overexpressing breast cancer through induction of calreticulin exposure by Tras-Permut CrossMab.Oncoimmunology · 2015Article
- Prognostic and predictive values of EGFR overexpression and EGFR copy number alteration in HER2-positive breast cancer.British journal of cancer · 2015Article
- Efficacy and mechanism of action of the tyrosine kinase inhibitors gefitinib, lapatinib and neratinib in the treatment of HER2-positive breast cancer: preclinical and clinical evidence.American journal of cancer research · 2015Review
- Article
- Human epidermal growth factor receptor family-targeted therapies in the treatment of HER2-overexpressing breast cancer.The oncologist · 2014Review
- Safety and feasibility of targeted agent combinations in solid tumours.Nature reviews. Clinical oncology · 2013Review
- Human epidermal growth factor receptor-2-positive breast cancer: does estrogen receptor status define two distinct subtypes?Annals of oncology : official journal of the European Society for Medical Oncology · 2013Review
- Increased expression of epidermal growth factor receptor (EGF-R) in patients with different forms of lung fibrosis.BioMed research international · 2013Article
- Role of epidermal growth factor receptor in breast cancer.Breast cancer research and treatment · 2012Review
- Attacking a nexus of the oncogenic circuitry by reversing aberrant eIF4F-mediated translation.Molecular cancer therapeutics · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 7 institutions in 1 country.
Funding
Abstract
purposeTo determine the safety, and efficacy of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib in combination with trastuzumab in patients with metastatic HER2-positive metastatic breast cancer. EXPERIMENTAL
designPatients with HER2-overexpressing breast cancer were treated with trastuzumab 2 mg/kg/week and gefitinib 250 to 500 mg/day. The primary end point of the study was to increase the proportion progression-free from 50% to 65% at 6 months in chemotherapy-naive patients and from 50% to 70% at 3 months in patients previously treated with chemotherapy in the metastatic setting.
resultsIn the phase I study, all patients treated with gefitinib 500 mg/day developed grade 3 diarrhea. The phase II study was conducted using trastuzumab and gefitinib 250 mg/day. One patient achieved a complete response, 2 had a partial response, and 6 had stable disease for an overall response rate of 9% and a clinical benefit rate of 28% (9 of 32). Median time to progression (TTP) was 3 months (95% confidence interval, 2.3-4.1) in patients with no prior systemic therapy in the metastatic setting (n = 23). In patients treated with prior systemic therapy (n = 9), the median TTP of 5.3 months (95% confidence interval, 2.8-8.1). Overall median survival was 27 months. TTP was similar in EGFR-positive compared with EGFR-negative patients.
conclusionsGefitinib 250 mg/day was the maximal dose that can be safely administered with weekly trastuzumab. Interim analysis of the efficacy suggested that the combination was unlikely to result in clinical benefit compared with trastuzumab alone. These results do not support the use of this combination in patients with HER2-positive breast cancer.
Indexed as
Identifiers
What OpenQuestion holds
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.