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HCRN BRE12-158

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

Status: Closed to Accrual

This study will test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard.

  • Condition: Triple Negative (ER-/PR-/HER2-) Invasive Breast Cancer
  • Intervention:
    • Drug: Genomically Directed Monotherapy
    • Other: Observation/Standard Therapy
  • Phase: Phase 2

Learn more:

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

Manuscripts/Articles:

  • 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.

Study Contact: studies@hoosiercancer.org; (317) 921-2050.