Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
Comparison of Radiation With or Without Concurrent Trastuzumab for HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy: A Phase III Clinical Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 28 citations in OpenAlex.
- Large Language Models for Supporting Clear Writing and Detecting Spin in Randomized Controlled Trials in Oncology: Comparative Analysis of GPT Models and Prompts.JMIR cancer · 2026Article
- Ten-Year Follow-up Clinical Outcomes and the Role of Adjuvant Chemotherapy in HER2-Positive Patients with Microinvasive Breast Cancer.Cancer research and treatment · 2026Article
- Cooperative CCL2/CCR2 and HGF/MET signaling enhances breast cancer growth and invasion associated with metabolic reprogramming.Cancer biology & therapy · 2025Article
- Quantitative assessment of HER2 expression in invasive ductal carcinoma and co-existing DCIS.Breast cancer research and treatment · 2025Article
- Case Report: Breast ductal carcinomaFrontiers in oncology · 2025Article
- Systematic assessment of HER2 status in ductal carcinoma in situ of the breast: a perspective on the potential clinical relevance.Breast cancer research : BCR · 2024Review
- Landscape of Endometrial Cancer: Molecular Mechanisms, Biomarkers, and Target Therapy.Cancers · 2024Review
- Article
- Tools to Guide Radiation Oncologists in the Management of DCIS.Healthcare (Basel, Switzerland) · 2024Review
- Progression from ductal carcinoma in situ to invasive breast cancer: molecular features and clinical significance.Signal transduction and targeted therapy · 2024Review
- Combined trastuzumab and radiation therapy for HER2-positive uterine serous carcinoma: A case report.Gynecologic oncology reports · 2023Article
- Clinical significance of microinvasive breast cancer across the different subtypes and human epidermal growth factor receptor 2 expression levels.Breast cancer research and treatment · 2023Article
- Outcomes in patients with non-invasive breast carcinoma.Cancer reports (Hoboken, N.J.) · 2023Article
- Major hurdles to the use of tyrosine kinase inhibitors in clinical prevention/interception studies: Do preclinical studies with EGFR inhibitors suggest approaches to overcome some of the limitations.Frontiers in cell and developmental biology · 2023Review
- Molecular subtypes predict second breast events of ductal carcinoma in situ after breast-conserving surgery.Cancer medicine · 2022Article
- Article
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Authors and funding
20 authors at 18 institutions in 1 country.
Funding
Abstract
purposePreclinical studies report that trastuzumab (T) can boost radiotherapy (RT) effectiveness. The primary aim of the B-43 trial was to assess the efficacy of RT alone vs concurrent RT plus T in preventing recurrence of ipsilateral breast cancer (IBTR) in women with ductal carcinoma in situ (DCIS). PATIENTS AND
methodsEligibility: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, DCIS resected by lumpectomy, known estrogen receptor (ER) and/or progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) status by centralized testing. Whole-breast RT was given concurrently with T. Stratification was by menopausal status, adjuvant endocrine therapy plan, and nuclear grade. Definitive intent-to-treat primary analysis was to be conducted when either 163 IBTR events occurred or all accrued patients were on study ≥ 5 years.
resultsThere were 2,014 participants who were randomly assigned. Median follow-up time as of December 31, 2019, was 79.2 months. At primary definitive analysis, 114 IBTR events occurred: RT arm, 63 and RT plus T arm, 51 (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.17;
conclusionAddition of T to RT did not achieve the objective of 36% reduction in IBTR rate but did achieve a modest but statistically nonsignificant reduction of 19%. Nonetheless, this trial had negative results. Further exploration of RT plus T is needed in HER2-positive DCIS before its routine delivery in patients with DCIS resected by lumpectomy.
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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.