Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011
Gefitinib or placebo in combination with tamoxifen in patients with hormone receptor-positive metastatic breast cancer: a randomized phase II study.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 2 of them syntheses that pooled it.
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
82 citing papers in PubMed, 2 syntheses or guidelines pooled it, 181 citations in OpenAlex.
- Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HRFrontiers of medicine · 2021Pooled it
- The efficacy of gefitinib supplementation for breast cancer: A meta-analysis of randomized controlled studies.Medicine · 2020Pooled it
- A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and GiotrifJournal of cancer research and clinical oncology · 2023Trial
- Neoadjuvant tamoxifen synchronizes ERα binding and gene expression profiles related to outcome and proliferation.Oncotarget · 2016Trial
- Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.Annals of oncology : official journal of the European Society for Medical Oncology · 2014Trial
- Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial.British journal of cancer · 2013Trial
- A phase II neoadjuvant trial of anastrozole, fulvestrant, and gefitinib in patients with newly diagnosed estrogen receptor positive breast cancer.Breast cancer research and treatment · 2011Trial
- A phase II study of the histone deacetylase inhibitor vorinostat combined with tamoxifen for the treatment of patients with hormone therapy-resistant breast cancer.British journal of cancer · 2011Trial
- A Bayesian Treatment Selection Design for Phase II Randomised Cancer Clinical Trials.Statistics in medicine · 2026Article
- Review
- Busting the Breast Cancer with AstraZeneca's Gefitinib.Advances in pharmacological and pharmaceutical sciences · 2023Review
- Bibliometric analysis and visualization of endocrine therapy for breast cancer research in the last two decade.Frontiers in endocrinology · 2023Article
- Beyond HER2: Targeting the ErbB receptor family in breast cancer.Cancer treatment reviews · 2022Review
- GLUT1 participates in tamoxifen resistance in breast cancer cells through autophagy regulation.Naunyn-Schmiedeberg's archives of pharmacology · 2021Article
- Currently Applied Molecular Assays for IdentifyingInternational journal of molecular sciences · 2020Review
- Compensatory Estrogen Signal Is Capable of DNA Repair in Antiestrogen-Responsive Cancer Cells via Activating Mutations.Journal of oncology · 2020Review
- Lipid metabolic reprogramming as an emerging mechanism of resistance to kinase inhibitors in breast cancer.Cancer drug resistance (Alhambra, Calif.) · 2020Article
- Advances in Endocrine-Based Therapies for Estrogen Receptor-Positive Metastatic Breast Cancer.Drugs · 2019Review
- Estrogen conjugated fluorescent silica nanoparticles as optical probes for breast cancer cells imaging.Biomicrofluidics · 2019Article
- CIK cell-based delivery of recombinant adenovirus KGHV500 carrying the anti-p21Ras scFv gene enhances the anti-tumor effect and safety in lung cancer.Journal of cancer research and clinical oncology · 2019Article
22 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 4 countries.
Funding
Abstract
purposeIncreased growth factor signaling may contribute to tamoxifen resistance. This randomized phase II trial assessed tamoxifen plus placebo or the epidermal growth factor receptor inhibitor gefitinib in estrogen receptor (ER)-positive metastatic breast cancer. EXPERIMENTAL
designPatients with newly metastatic disease or recurred after adjuvant tamoxifen (stratum 1), or recurred during/after adjuvant aromatase inhibitor (AI) or after failed first-line AI (stratum 2), were eligible. Primary variables were progression-free survival (PFS; stratum 1) and clinical benefit rate (CBR; stratum 2). A 5% or more improvement in response variables with gefitinib was considered to warrant further investigation. Outcome was correlated with biomarkers measured on the primary tumor.
resultsIn stratum 1 (n = 206), the PFS HR (gefitinib:placebo) was 0.84 (95% CI, 0.59-1.18; median PFS 10.9 versus 8.8 months). In the stratum 1 endocrine therapy-naïve subset (n = 158) the HR was 0.78 (95% CI, 0.52-1.15), and the prior endocrine-treated subgroup (n = 48) 1.47 (95% CI, 0.63-3.45). In stratum 1, CBRs were 50.5% with gefitinib and 45.5% with placebo. In stratum 2 (n = 84), CBRs were 29.2% with gefitinib and 31.4% with placebo. Biomarker analysis suggested that in stratum 1 there was greater benefit with gefitinib in patients who were ER-negative or had lower levels of ER protein.
conclusionsIn stratum 1, the improved PFS with gefitinib plus tamoxifen met the protocol criteria to warrant further investigation of this strategy. In stratum 2, there was a numerical disadvantage for gefitinib; additional investigation after AI therapy is not warranted. Studies of predictive biomarkers are needed to subset appropriate patients.
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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.