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BMC Cancer
Published in: BMC Cancer 1/2023

Open Access 01-12-2023 | Breast Cancer | Study Protocol

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

Authors: Yasmin A. Civil, Arlene L. Oei, Katya M. Duvivier, Nina Bijker, Philip Meijnen, Lorraine Donkers, Sonja Verheijen, Zdenko van Kesteren, Miguel A. Palacios, Laura J. Schijf, Ellis Barbé, Inge R. H. M. Konings, C. Willemien Menke -van der Houven van Oordt, Paulien G. Westhoff, Hanneke J. M. Meijer, Gwen M. P. Diepenhorst, Victor Thijssen, Florent Mouliere, Berend J. Slotman, Susanne van der Velde, H. J. G. Desirée van den Bongard

Published in: BMC Cancer | Issue 1/2023

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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).
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Metadata
Title
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
Authors
Yasmin A. Civil
Arlene L. Oei
Katya M. Duvivier
Nina Bijker
Philip Meijnen
Lorraine Donkers
Sonja Verheijen
Zdenko van Kesteren
Miguel A. Palacios
Laura J. Schijf
Ellis Barbé
Inge R. H. M. Konings
C. Willemien Menke -van der Houven van Oordt
Paulien G. Westhoff
Hanneke J. M. Meijer
Gwen M. P. Diepenhorst
Victor Thijssen
Florent Mouliere
Berend J. Slotman
Susanne van der Velde
H. J. G. Desirée van den Bongard
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-023-10910-6

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