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.

Authors

null

Steven J. Chmura

The University of Chicago Hospitals, Chicago, IL

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

Organizations

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

Research Funding

NIH

Background: This is a randomized Phase II trial to evaluate if stereotactic body radiotherapy (SBRT) and/or surgical resection (SR) of all metastatic sites in oligo-metastatic breast cancer who have received up to 6 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 (OS). Secondary aims include local control in the metastatic site, 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. Predictive value of CTCs will be assessed. Methods: Women with pathologically confirmed metastatic breast cancer to < / = 2 sites who have received up to 6 months of standard first line systemic therapy and the primary site disease is controlled are eligible. CNS metastases are ineligible. ER/PR and HER-2 neu is required on the primary or metastatic site. Site radiation credentialing with a facility questionnaire and a case benchmark is required. Randomization is to local radiotherapy/ surgery for palliation only when necessary versus ablation of all metastases with SBRT and/or SR. Statistics: For the phase IIR portion to detect a signal for improved median PFS from 10.5 to 19 months with 95% power and accounting for ineligible/lost patients, 146 patients will be required. For the Phase III, an additional 246 patients will be required to definitively determine if ablative therapy improves 5-year OS 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, the number of patients accrued in Phase IIR and Phase III portions will provide sufficient power of at least 91% to detect whether < 5 CTC’s is a prognostic marker for improved PFS and OS. Contact Information: Protocol: CTSU member web site https://www.ctsu.org. Pt enrollment: OPEN at https://open.ctsu.orgor the OPEN tab on CTSU member web site. Support: NCI U10CA180868 and U10CA180822 Clinical trial information: Pending.

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy

Track

Breast Cancer

Sub Track

Local Therapy

Clinical Trial Registration Number

Pending

Citation

J Clin Oncol 33, 2015 (suppl; abstr TPS1105)

DOI

10.1200/jco.2015.33.15_suppl.tps1105

Abstract #

TPS1105

Poster Bd #

216b

Abstract Disclosures

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