Trial reportBreast cancer research and treatment2013
A randomized, double-blind, controlled study of exemestane versus anastrozole for the first-line treatment of postmenopausal Japanese women with hormone-receptor-positive advanced breast cancer.
Trial report in Breast cancer research and treatment, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 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
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review.JAMA network open · 2021Pooled it
- Aromatase inhibitors and risk of cardiovascular events in breast cancer patients: a systematic review and meta-analysis.BMC pharmacology & toxicology · 2019Pooled it
- Surrogate threshold effect based on a meta-analysis for the predictive value of progression-free survival for overall survival in hormone receptor-positive, HER2-negative metastatic breast cancer.Breast cancer research and treatment · 2019Pooled it
- Incidence of menopausal symptoms in postmenopausal breast cancer patients treated with aromatase inhibitors.Oncotarget · 2017Pooled it
- Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis.Breast cancer (Tokyo, Japan) · 2025Trial
- Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study.Cancer science · 2018Trial
- Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study.Journal of the National Cancer Institute · 2025Article
- Aromatase Inhibitors and Plasma Lipid Changes in Postmenopausal Women with Breast Cancer: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2024Review
- Article
- Aromatase Inhibitors and Risk of Metabolic and Cardiovascular Adverse Effects in Breast Cancer Patients-A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2022Review
- Neuro-immune-endocrine mechanisms with poor adherence to aromatase inhibitor therapy in breast cancer.Frontiers in oncology · 2022Review
- Real-World First-Line Treatment Patterns and Outcomes in Hormone Receptor-Positive Advanced Breast Cancer Patients: A Multicenter, Retrospective Study in China.Frontiers in oncology · 2022Article
- Palbociclib as an early-line treatment for Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: a review of clinical trial and real-world data.International journal of clinical oncology · 2021Review
- Review
- Review
- Aromatase Inhibitor-Associated Musculoskeletal Syndrome: Understanding Mechanisms and Management.Frontiers in endocrinology · 2021Review
- A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials.European journal of clinical pharmacology · 2020Article
- Association of adjuvant aromatase inhibitor with cataract risk in postmenopausal women with breast cancer.Annals of translational medicine · 2020Article
- ACT-FASTER, a Prospective Cohort Study Exploring Treatment Patterns with Fulvestrant and Exemestane in Postmenopausal Patients with Advanced Hormone Receptor-Positive Breast Cancer under Real-Life Conditions in Germany.Breast care (Basel, Switzerland) · 2019Article
- Review
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 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aromatase inhibitors exemestane and anastrozole are approved in Japan for first-line treatment of postmenopausal patients with advanced, hormone-receptor-positive breast cancer. This phase 3, randomized, double-blind study directly compared time to progression (TTP) for exemestane and anastrozole therapy in this patient population. Eligible patients were randomized to receive exemestane 25 mg or anastrozole 1 mg, each once daily. The primary endpoint was TTP based on assessment by an expert radiologic images review committee (ERIRC). Secondary endpoints included investigator-assessed TTP, time to treatment failure, overall survival, objective response rate, clinical benefit rate, and safety. A total 298 patients were randomized to receive exemestane (n = 149; mean age 63.4 years) or anastrozole (n = 149; mean age 64.0 years). Median ERIRC-assessed TTP was 13.8 and 11.1 months (hazard ratio = 1.007; 95 % confidence interval [CI]: 0.771, 1.317) and median investigator-assessed TTP was 13.8 and 13.7 months (hazard ratio = 1.059; 95 % CI: 0.816, 1.374) in the exemestane and anastrozole arms, respectively. Median overall survival was 60.1 months in the anastrozole arm and was not reached in the exemestane arm at data cutoff. The objective response rate was 43.9 % (95 % CI: 35.3, 52.8) and 39.1 % (95 % CI: 30.6, 48.1) in the exemestane and anastrozole arms, respectively. Treatment-related adverse events grade ≥3 occurred in 9.4 and 6.0 % of patients, and treatment-related serious adverse events occurred in 4.0 and 3.4 % of patients in the exemestane and anastrozole arms, respectively. In this study, the efficacy and safety profiles of exemestane were similar to those of anastrozole in Japanese patients with advanced, hormone-receptor-positive breast cancer; however, TTP non-inferiority of exemestane versus anastrozole was not confirmed.
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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.