Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial—a study protocol
-
Published:2023-05-09
Issue:1
Volume:23
Page:
-
ISSN:1471-2407
-
Container-title:BMC Cancer
-
language:en
-
Short-container-title:BMC Cancer
Author:
Civil Yasmin A.,Oei Arlene L.,Duvivier Katya M.,Bijker Nina,Meijnen Philip,Donkers Lorraine,Verheijen Sonja,van Kesteren Zdenko,Palacios Miguel A.,Schijf Laura J.,Barbé Ellis,Konings Inge R. H. M.,-van der Houven van Oordt C. Willemien Menke,Westhoff Paulien G.,Meijer Hanneke J. M.,Diepenhorst Gwen M. P.,Thijssen Victor,Mouliere Florent,Slotman Berend J.,van der Velde Susanne,van den Bongard H. J. G. Desirée
Abstract
Abstract
Background
Partial breast irradiation (PBI) is standard of care in low-risk breast cancer patients after breast-conserving surgery (BCS). Pre-operative PBI can result in tumor downstaging and more precise target definition possibly resulting in less treatment-related toxicity. This study aims to assess the pathologic complete response (pCR) rate one year after MR-guided single-dose pre-operative PBI in low-risk breast cancer patients.
Methods
The ABLATIVE-2 trial is a multicenter prospective single-arm trial using single-dose ablative PBI in low-risk breast cancer patients. Patients ≥ 50 years with non-lobular invasive breast cancer ≤ 2 cm, grade 1 or 2, estrogen receptor-positive, HER2-negative, and tumor-negative sentinel node procedure are eligible. A total of 100 patients will be enrolled. PBI treatment planning will be performed using a radiotherapy planning CT and -MRI in treatment position. The treatment delivery will take place on a conventional or MR-guided linear accelerator. The prescribed radiotherapy dose is a single dose of 20 Gy to the tumor, and 15 Gy to the 2 cm of breast tissue surrounding the tumor. Follow-up MRIs, scheduled at baseline, 2 weeks, 3, 6, 9, and 12 months after PBI, are combined with liquid biopsies to identify biomarkers for pCR prediction. BCS will be performed 12 months after radiotherapy or after 6 months, if MRI does not show a radiologic complete response. The primary endpoint is the pCR rate after PBI. Secondary endpoints are radiologic response, toxicity, quality of life, cosmetic outcome, patient distress, oncological outcomes, and the evaluation of biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 10 years after radiation therapy.
Discussion
This trial will investigate the pathological tumor response after pre-operative single-dose PBI after 12 months in patients with low-risk breast cancer. In comparison with previous trial outcomes, a longer interval between PBI and BCS of 12 months is expected to increase the pCR rate of 42% after 6–8 months. In addition, response monitoring using MRI and biomarkers will help to predict pCR. Accurate pCR prediction will allow omission of surgery in future patients.
Trial registration
The trial was registered prospectively on April 28th 2022 at clinicaltrials.gov (NCT05350722).
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Reference62 articles.
1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. 2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7–33. 3. Ward ZJ, Atun R, Hricak H, Asante K, McGinty G, Sutton EJ, et al. The impact of scaling up access to treatment and imaging modalities on global disparities in breast cancer survival: a simulation-based analysis. Lancet Oncol. 2021;22(9):1301–11. 4. Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, et al. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019;69(5):363–85. 5. van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, et al. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000;92(14):1143–50.
|
|