Trial reportBreast cancer research and treatment2013
Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43.
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 25 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.
- The adverse effects of trastuzumab-containing regimes as a therapy in breast cancer: A piggy-back systematic review and meta-analysis.PloS one · 2022Pooled it
- Prognostic and Predictive Value of HER2 Expression in Ductal Carcinoma In Situ: Results from the UK/ANZ DCIS Randomized Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Trial
- 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
- Progression from ductal carcinoma in situ to invasive breast cancer: molecular features and clinical significance.Signal transduction and targeted therapy · 2024Review
- An overview of invasive micropapillary carcinoma of the breast: past, present, and future.Frontiers in oncology · 2024Review
- Molecular subtyping reveals uniqueness of prognosis in breast ductal carcinoma in situ patients with lumpectomy.Breast (Edinburgh, Scotland) · 2022Article
- Article
- The impact of HER2-directed targeted therapy on HER2-positive DCIS of the breast.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2021Article
- Factors predictive of invasive ductal carcinoma in cases preoperatively diagnosed as ductal carcinoma in situ.BMC cancer · 2020Article
- HER2 overexpression in ductal carcinoma in situ is associated with ipsilateral breast cancer recurrence after conservative surgery.Translational cancer research · 2020Article
- Somatic mutations and copy number variations in breast cancers with heterogeneous HER2 amplification.Molecular oncology · 2020Article
- A retrospective alternative for active surveillance trials for ductal carcinoma in situ of the breast.International journal of cancer · 2020Review
- Current Therapeutic Approaches to DCIS.Journal of mammary gland biology and neoplasia · 2018Review
- Clinical Trials for Ductal Carcinoma In Situ of the Breast.Journal of mammary gland biology and neoplasia · 2018Review
- Comparison of HER2 amplification status among breast cancer subgroups offers new insights in pathways of breast cancer progression.Virchows Archiv : an international journal of pathology · 2017Article
- HER2 isoforms co-expression differently tunes mammary tumor phenotypes affecting onset, vasculature and therapeutic response.Oncotarget · 2017Article
- Paradigm Shift toward Reducing Overtreatment of Ductal CarcinomaFrontiers in oncology · 2017Review
- CD8(+) tumor-infiltrating lymphocytes contribute to spontaneous "healing" in HER2-positive ductal carcinoma in situ.Cancer medicine · 2016Article
- Molecular classification of non-invasive breast lesions for personalised therapy and chemoprevention.Oncotarget · 2015Article
Corrections and comments
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Authors and funding
18 authors at 10 institutions in 1 country.
Funding
Abstract
NSABP B-43 is the first prospective, randomized phase III multi-institution clinical trial targeting high-risk, HER2-positive DCIS. It compares whole breast irradiation alone with WBI given concurrently with trastuzumab in women with HER2-positive DCIS treated by lumpectomy. The primary aim is to determine if trastuzumab plus radiation will reduce in-breast tumor recurrence. HER2-positive DCIS was previously estimated at >50 %, occurring primarily in ER-negative, comedo-type DCIS of high nuclear grade. There has been no documented centralized multi-institutional HER2 analysis of DCIS. NSABP B-43 provides a unique opportunity to evaluate this in a large cohort of DCIS patients. Patients undergoing lumpectomy for DCIS without evidence of an invasive component are eligible. A central review of each patient's pure DCIS lesion is carried out by immunohistochemistry analysis. If the lesion is 2+, FISH analysis is performed. Patients whose tumors are HER2 3+ or FISH-positive are randomly assigned to receive two doses of trastuzumab during WBI or WBI alone. NSABP B-43 opened 11/9/08. As of 7/31/2013, 5,861 patients have had specimens received centrally, and 5,645 of those had analyzable blocks; 1,969 (34.9 %) were HER2 positive. A total of 1,428 patients have been accrued, 1,137 (79.6 %) of whom have follow-up information. The average follow-up time for the 1,137 patients is 23.3 months. No grade 4 or 5 toxicity has been observed. In NSABP B-43 the HER2-positive rate for pure DCIS among patients undergoing breast-preserving surgery is 34.9 %, lower than the previously reported rate. No trastuzumab-related safety signals have been observed. Interest in this trial has been robust.
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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.