Evidence map›Paper›PMID 42028343›Full record

ArticleClinical and translational radiation oncology2026

Single fraction based-partial breast irradiation: 10-year results of the SiFEBI phase 2 prospective trial.

Laura Haas, Jocelyn Gal, Mathieu Gauthier, Renaud Schiappa, Jean-Michel Hannoun-Levi

Registry-linked trialAbstract read
In one paragraph

Article in Clinical and translational radiation oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01727011 (A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from 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.

2 · The registry

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.

NCT01727011 nacompletednot on this map

A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence

TypeinterventionalSponsorCentre Antoine LacassagneRan2012 to 2015Enrolled37ConditionsBreast CancerArmsIPAS
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Laura HaasDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University Côte d'Azur, Nice, France.
Jocelyn GalDepartment of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France.
Mathieu GauthierDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University Côte d'Azur, Nice, France.
Renaud SchiappaDepartment of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France.
Jean-Michel Hannoun-LeviDepartment of Radiation Oncology, Antoine Lacassagne Cancer Center, University Côte d'Azur, Nice, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This analysis updates the SiFEBI phase 2 trial (NCT01727011) evaluating accelerated partial breast irradiation (APBI) delivered as a single fraction (sfPBI) of postoperative multicatheter interstitial HDR brachytherapy (MIB) in elderly patients with low-risk breast cancer. Materials and methods: Patients aged ≥ 70 years (Balducci I-II) with low-risk breast cancer were enrolled. After lumpectomy, intraoperative catheter implantation was performed and postoperative sfPBI (16 Gy) was delivered. The primary endpoint was cumulative incidence of local recurrence (ciLR). Secondary endpoints included cumulative incidence of distant metastasis (ciDM), cancer-specific survival (CSS), overall survival (OS), late toxicity, cosmetic outcome, and endocrine-therapy (ET) adherence. Results: From 11/12 to 09/14, 26 patients were enrolled. Median age was 76.6 years; median tumour size was 10.4 mm. Most tumours were invasive ductal carcinoma (76.5%), all of luminal subtype. After a median follow-up of 137 months, 10-year ciLR was 5%. Ten-year ciDM, CSS, and OS were 0%, 100%, and 81%, respectively. Late toxicity was observed in 9 patients (34.6%) with a total of 12 events (G1: 83.3%, G2: 16.6%). Reported late effects included breast pain, hypopigmentation, telangiectasia and breast fibrosis. Ten-year cosmetic outcomes were reported in 18 pts as excellent in 14 patients (77.8%) and good in 4 patients (22.2%). Median ET duration was 59 months; 14 pts (53.8%) were non-adherent. Conclusion: In this elderly, low-risk cohort, single fraction postoperative MIB sfPBI provided excellent long-term oncological outcomes with acceptable toxicity and cosmesis. Larger studies with extended follow-up are warranted.

Indexed as

BrachytherapyBreast cancerFractionationSingle fractionToxicityTreatment de-escalationVery accelerated partial breast irradiation (APBI)

Identifiers

PMID42028343
PMCPMC13101662

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Registered trials

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