Trial reportJournal of the National Cancer Institute2023
Ten-year update: NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-42 randomized trial: extended letrozole therapy in early-stage breast cancer.
Trial report in Journal of the National Cancer Institute, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers.
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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.
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Who cites it
12 citing papers in PubMed, 17 citations in OpenAlex.
- Differential long-term tamoxifen therapy benefit by menopausal status in breast cancer patients: secondary analysis of a controlled randomized clinical trial.Journal of the National Cancer Institute · 2025Trial
- Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-Positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Optimizing Extended Adjuvant Endocrine Therapy in Early HR+/HER2- Breast Cancer: The Emerging Role of Genomic Assays and ctDNA MRD.Advances in therapy · 2026Review
- Development and Validation of a Multimodal-Multitask Deep Learning Approach for Estimating Late Distant Recurrence Risk in HR-Positive Early Breast Cancer.Cancer research communications · 2026Article
- Engineering Folic Acid-Modified Nanoparticles to Enhance Letrozole's Anticancer Action.Macromolecular bioscience · 2025Article
- Clinical treatment score post-5 years and survival benefit from extended endocrine therapy for breast cancer patients under and over 50 years of age.Breast cancer research and treatment · 2025Article
- Extended adjuvant endocrine therapy in early breast cancer: finding the individual balance.ESMO open · 2025Review
- Adjuvant endocrine treatment strategies for non-metastatic breast cancer: a network meta-analysis.EClinicalMedicine · 2025Article
- A narrative review: research progress of adjuvant intensive endocrine therapy for early breast cancer.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2024Review
- Diabetes mellitus in breast cancer survivors: metabolic effects of endocrine therapy.Nature reviews. Endocrinology · 2024Review
- Are we there yet? Optimal duration of endocrine therapy in women with postmenopausal early-stage hormone receptor-positive breast cancer.Journal of the National Cancer Institute · 2023Article
- Focusing on the Advances and Challenges of HER2-Targeted Therapy: Cutting-Edge Breakthroughs in Neoadjuvant Treatment for HER2-Positive Breast Cancer.Technology in cancer research & treatmentReview
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
16 authors at 11 institutions in 3 countries.
Funding
Abstract
backgroundThe National Surgical Adjuvant Breast and Bowel Project B-42 trial evaluated extended letrozole therapy (ELT) in postmenopausal breast cancer patients who were disease free after 5 years of aromatase inhibitor (AI)-based therapy. Seven-year results demonstrated a nonstatistically significant trend in disease-free survival (DFS) in favor of ELT. We present 10-year outcome results.
methodsIn this double-blind, phase III trial, patients with stage I-IIIA hormone receptor-positive breast cancer, disease free after 5 years of an AI or tamoxifen followed by an AI, were randomly assigned to 5 years of letrozole or placebo. Primary endpoint was DFS, defined as time from random assignment to breast cancer recurrence, second primary malignancy, or death. All statistical tests are 2-sided.
resultsBetween September 2006 and January 2010, 3966 patients were randomly assigned (letrozole: 1983; placebo: 1983). Median follow-up time for 3923 patients included in efficacy analyses was 10.3 years. There was statistically significant improvement in DFS in favor of letrozole compared with placebo (hazard ratio [HR] = 0.85, 95% confidence interval [CI] = 0.74 to 0.96; P = .01; 10-year DFS: placebo = 72.6%, letrozole = 75.9%, absolute difference = 3.3%). There was no difference in the effect of letrozole on overall survival (HR = 0.97, 95% CI = 0.82 to 1.15; P = .74). Letrozole statistically significantly reduced breast cancer-free interval events (HR = 0.75, 95% CI = 0.62 to 0.91; P = .003; absolute difference in cumulative incidence = 2.7%) and distant recurrences (HR = 0.72, 95% CI = 0.55 to 0.92; P = .01; absolute difference = 1.8%). The rates of osteoporotic fractures and arterial thrombotic events did not differ between treatment groups.
conclusionsThe beneficial effect of ELT on DFS persisted at 10 years. Letrozole also improved breast cancer-free interval and distant recurrences without improving overall survival. Careful assessment of potential risks and benefits is necessary for selecting appropriate candidates for ELT.
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