Trial reportBMC cancer2018
Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node.
Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01717131 (A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer), which is not on this map. Cited by 15 papers, 2 of them syntheses 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.
A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Axillary dissection versus axillary observation for low risk, clinically node-negative invasive breast cancer: a systematic review and meta-analysis.Breast cancer (Tokyo, Japan) · 2021Pooled it
- Comparing Observation, Axillary Radiotherapy, and Completion Axillary Lymph Node Dissection for Management of Axilla in Breast Cancer in Patients with Positive Sentinel Nodes: A Systematic Review.Annals of surgical oncology · 2020Pooled it
- Risk of Residual Axillary Lymph Node Macrometastasis in Early Breast Cancer PATIENTS with One Positive Macrometastasis Sentinel Lymph Node.OncoTargets and therapy · 2025Article
- Postoperative Outcomes of Pre-Pectoral Versus Sub-Pectoral Implant Immediate Breast Reconstruction.Cancers · 2024Article
- The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases.Cancer medicine · 2023Article
- Axillary surgery in node-positive breast cancer.Breast (Edinburgh, Scotland) · 2022Article
- Intraoperative prediction of non-sentinel lymph node metastases in breast cancer using cytokeratin 19 mRNA copy number: A retrospective analysis.Molecular and clinical oncology · 2022Article
- Impact of Post-Mastectomy Radiation Therapy for Sentinel Lymph Node Micrometastases in Early-Stage Breast Cancer Patients.Medical science monitor : international medical journal of experimental and clinical research · 2022Article
- Mastectomy and Immediate Breast Reconstruction with Pre-Pectoral or Sub-Pectoral Implant: Assessing Clinical Practice, Post-Surgical Outcomes, Patient's Satisfaction and Cost.Journal of surgery and research · 2022Article
- Survival and recurrence with or without axillary dissection in patients with invasive breast cancer and sentinel node metastasis.Scientific reports · 2021Article
- Article
- Robotic Versus Conventional Nipple-Sparing Mastectomy With Immediate Breast Reconstruction.Frontiers in oncology · 2021Article
- Mastectomy with immediate breast reconstruction: Results of a mono-centric 4-years cohort.Annals of medicine and surgery (2012) · 2021Article
- Article
- A Radiation Oncologist's Guide to Axillary Management in Breast Cancer: A Walk Through the Trials.Current breast cancer reports · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
29 authors at 16 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThree randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included.
methodsSERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement.
resultsOf the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy.
conclusionThe main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed.
trial registrationThis study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.
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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.