NRG-BR002: A phase IIR/III trial of standard of care therapy with or without stereotactic body radiotherapy (SBRT) and/or surgical ablation for newly oligometastatic breast cancer (NCT02364557).

Authors

null

Steven J. Chmura

The University of Chicago Medicine, Chicago, IL

Steven J. Chmura , Kathryn A. Winter , Hania A Al-Hallaq , Virginia F. Borges , Nora T. Jaskowiak , Martha Matuszak , Michael T. Milano , Joseph Kamel Salama , Wendy A. Woodward , Julia R. White

Organizations

The University of Chicago Medicine, Chicago, IL, Statistical Center, Radiation Therapy Oncology Group, Philadelphia, PA, The University of Chicago, Chicago, IL, University of Colorado Comprehensive Cancer Center, Aurora, CO, University of Chicago, Chicago, IL, University of Michigan, Ann Arbor, MI, University of Rochester Medical Center, Rochester, NY, Duke University Medical Center, Durham, NC, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, NRG Oncology, and The Ohio State University Comprehensive Cancer Center, Columbus, OH

Research Funding

Other Government Agency

Background: This is a randomized Phase II/III trial to evaluate if stereotactic body radiotherapy (SBRT) and/or surgical resection (SR) of all metastatic sites in newly oligo-metastatic breast cancer who have received up to 12 months of first line systemic therapy without progression will significantly improve median progression free survival (PFS). If this aim is met the trial continues as a phase III to evaluate if SBRT/SR improves 5 year overall survival. Secondary aims include local control in the metastatic site, new distant metastatic rate, and technical quality. Translational primary endpoint is to determine whether < 5 CTCs is an independent prognostic marker for improved PFS and OS. Methods: Women with pathologically confirmed metastatic breast cancer to ≤ 4 sites who have been diagnosed within 365 days with metastatic disease and the primary tumor site disease is controlled. CNS metastases are ineligible. ER/PR and HER-2 neu status is required. Site radiation credentialing with a facility questionnaire and pre-treatment review of first case is required. Randomization is to standard systemic therapy with local radiotherapy/ surgery for palliation when necessary versus ablative therapy of all metastases with SBRT and/or SR. For the phase IIR portion to detect a signal for improved median PFS from 10.5 months to 19 months with 95% power and a 1-sided alpha of 0.15 and accounting for ineligible/lost patients, 128 patients will be required. For the Phase III, an additional 232 patients will be required to definitively determine if ablative therapy improves 5-year overall survival from 28% to 42.5% (HR=0.67), with 85% power and a one-sided type I error of 0.025. For the translational research assuming a two-sided probability of type I error of 0.05, the number of patients accrued in the Phase II-R and Phase III portions will provide sufficient power of at least 91% and 93% to detect whether < 5 CTC’s is prognostic for PFS and OS, respectively. Present accrual (1-31-2019): 105. Contact Information: Protocol: CTSU member web site https://www.ctsu.org. Enrollment: OPEN at https://open.ctsu.org. Support: This project is supported by NRG Oncology grants U10CA180868 and U10CA180822 from the National Cancer Institute (NCI). Translational science is supported by the Ludwig Foundation for Cancer Research. Clinical trial information: NCT02364557

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

Other Breast Cancer Subtypes

Clinical Trial Registration Number

NCT02364557

Citation

J Clin Oncol 37, 2019 (suppl; abstr TPS1117)

DOI

10.1200/JCO.2019.37.15_suppl.TPS1117

Abstract #

TPS1117

Poster Bd #

189b

Abstract Disclosures

Similar Abstracts

First Author: Corbin J. Eule

First Author: Prantik Das

First Author: Yicong Chen