A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer.

Manuscripts/Articles:

• Bryan P. Schneider,MD; Guanglong, Jiang,MS; Tarah J. Ballinger, MD; Fei Shen, MD; Christopher Chitambar, MD; Rita Nanda, MD; Carla Falkson, MBBch, PhD; Filipa C. Lynce , MD; Christopher Gallagher , MD; Claudine Isaacs , MD; Marcelo Blaya, MD; Elisavet Paplomata, MD; Radhika Walling, MD; Karen Daily , DO; Reshma Mahtani , DO; Michael A. Thompson , MD, PhD; Robert Graham, MD; Maureen E. Cooper, BS; Dean C. Pavlick , BS; Lee A. Albacker , PhD; Jeffrey Gregg, MD; Jeffrey P. Solzak , MS, MBA; Yu-Hsiang Chen, PhD; Casey L. Bales , MS; Erica Cantor , MS; Bradley A. Hancock, BS; Nawal Kassem , MD; Paul Helft, MD; Bert O’Neil, MD; Anna Maria V. Storniolo , MD; Sunil Badve , MBBS; Kathy D. Miller, MD; and Milan Radovich , PhD. BRE12-158: A Postneoadjuvant, Randomized Phase II Trial of Personalized Therapy Versus Treatment of Physician’s Choice for Patients with Residual Triple-Negative Breast Cancer. (BRE12-158) Journal of Clinical Oncology 40, no. 4 (February 01, 2022) 345-355. DOI: 10.1200/JCO.21.01657 See abstract. 
• M Radovich, G Jiang, BA Hancock, C Chitambar, R Nanda, C Falkson, FC Lynce, C Gallagher, C Isaacs, M Blaya, E Paplomata, R Walling, K Daily, R Mahtani, MA Thompson, R Graham, ME Cooper, DC Pavlick, LA Albacker, J Gregg, JP Solzak, Y Chen, CL Bales, E Cantor, F Shen, AMV Storniolo, S Badve, TJ Ballinger, C Chang, Y Zhong, C Savran, KD Miller, BP Schneider. Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial. JAMA Oncol. Published online July 09, 2020. doi:10.1001/jamaoncol.2020.2295. See abstract.
• Schneider B, Miller KD, Badve S, O’Neil B, Helft P, Chitambar C, Falkson C, Nanda R, McCormick M, Danso M, Blaya M, Langdon R, Lippman M, Paplomata E, Walling R, Thompson M, Robin E, Aggarwal L, Shalaby I, Canfield V, Adesunloye B, Lee T, Daily K, Ma C, Erban J, Radhakrishnan N, Bruetman D, Graham M, Reddy NA, Lynce FC, Radovich M. Abstract OT3-04-01: BRE12-158: A phase II randomized controlled trial of genomically directed therapy after preoperative chemotherapy in patients with triple negative breast cancer (TNBC). In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-04-01. See abstract.

Abstracts/Posters/Presentations:

• M Radovich, N Kassem, G Jiang, BA Hancock, BP Schneider. Circulating TP53 mutations in TNBC after neoadjuvant chemotherapy is associated with rapid disease recurrence: Correlative analysis from clinical trial BRE12-158. Spotlight Poster Discussion Session, San Antonio Breast Cancer Symposium 2020. See abstract.
• M Radovich, G Jiang, C Chitambar, R Nanda, C Falkson, FC Lynce, C Gallagher, C Isaacs, M Blaya, E Paplomata, R Walling, K Daily, R Mahtani, MA Thompson, R Graham, ME Cooper, DC Pavlick, L Albacker, J Gregg, CL Bales, BA. Hancock, E Cantor, F Shen, AMV Storniolo, S Badve, T Ballinger, KD Miller, BP Schneider. Detection of circulating tumor DNA (ctDNA) after neoadjuvant chemotherapy is significantly associated with disease recurrence in early-stage triple-negative breast cancer (TNBC): Preplanned correlative results from clinical trial BRE12-158. General Session, San Antonio Breast Cancer Symposium 2019. See abstract.
• Schneider B, Miller KD, Badve S, O’Neil B, Helft P, Chitambar C, Falkson C, Nanda R, McCormick M, Danso M, Blaya M, Langdon R, Lippman M, Paplomata E, Walling R, Thompson M, Robin E, Aggarwal L, Shalaby I, Canfield V, Adesunloye B, Lee T, Daily K, Ma C, Erban J, Radhakrishnan N, Bruetman D, Graham M, Reddy NA, Lynce FC, Radovich M. BRE12-158: A phase II randomized controlled trial of genomically directed therapy after preoperative chemotherapy in patients with triple negative breast cancer (TNBC). Ongoing Clinical Trials Poster, San Antonio Breast Cancer Symposium 2016. See abstract.

Learn more:

• IU researchers show rapid disease recurrence more likely in TNBC patients with TP53 mutations. (2/2/2021)
• Study finds presence of ctDNA and CTCs after neoadjuvant chemo in triple-negative breast cancer is associated with disease recurrence. (7/14/2020)
• IU School of Medicine researchers predict which triple negative breast cancer patients may avoid recurrence and which are at high-risk of relapse. (12/19/2019)
• Breast cancer trial incorporates advanced genomic technology. (5/16/2014)

For full description, see clinicaltrials.gov (#NCT02101385).