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Principal Investigator
Balazs Halmos
Awardee Organization

Montefiore Medical Center (Bronx, Ny)
United States

Fiscal Year
2025
Activity Code
UG1
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Montefiore Academic Communicty NCORP Program

The overall goals of the Montefiore Academic Community NCORP Program are to advance the prevention, diagnosis, and treatment of early-stage and advanced cancer by participating in NCORP trials as an Academic Community site and contributing scientifically and administratively to the NCORP research bases. This will be accomplished by leveraging the strengths of the Montefiore Health System (MHS), including Montefiore Medical Center (MMC), which brings strengths in integrated patient care and innovative health care delivery systems in an academic medical center serving a large population historically under-accrued in clinical trials, and the Albert Einstein College of Medicine (Einstein), which brings strengths in training and education, and in basic, translational, and clinical research through its NCI-designated comprehensive cancer center. The Montefiore -Einstein Comprehensive Cancer Center (MECCC) program also brings critical leadership/membership to the NCORP Research Bases, including ECOG-ACRIN, Alliance, and NRG, including leadership roles at the level of the scientific committee chair (or co-chair), and protocol chair (or co-chair). Our plans build upon our long-standing involvement in all aspects of cancer research as a main member of ECOG for 50 years and an NCI-designated cancer center for 53 years (having achieved now comprehensive status in 2023), and a strong history of accrual of under-accrued minorities to cancer treatment trials (about 65-80% of all patients). MMC serves the Bronx, an urban community of 1.47 million residents, of whom 89% belong to historically under-accrued populations and 29% live below the federal poverty level. In the prior funding period, we continued a strong track record of scientific contributions to the NCORP research bases, and following an anticipated dip during Covid years now have met and surpassed our accrual targets for the last two years with continued exceptionally strong participation of key under-accrued patient populations. In the next funding period, we will continue our strong investment in our portfolio of NCTN/NCORP clinical trials with a significant expansion of anticipated activities in the areas of cancer prevention and screening as a result of recent recruitment of key faculty/leadership. In addition, we plan to continue our robust investment in a range of NCORP cancer care delivery research (CCDR) and cancer therapeutic trials. The Montefiore Academic Community NCORP is led by senior faculty with complimentary experience in cancer therapeutics, cancer care delivery and research. Dr. Halmos will continue to serve as the contact PI and overall technical director, including the Cores and Programs, Dr. Rapkin will provide oversight of cancer control/prevention, and Dr. Ohri will provide oversight of therapeutic trials and will continue in his role as Associate Director for Symptom Science for the remainder of the current award period of the program. This steady leadership team is supported by additional faculty leading programs of cancer prevention and screening as well as robust administrative, regulatory and quality assurance team members.

Publications

  • Albain KS, Gray RJ, Makower DF, Faghih A, Hayes DF, Geyer CE, Dees EC, Goetz MP, Olson JA, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Wood WC, Keane MM, Gomez HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW, Sparano JA. Race, Ethnicity, and Clinical Outcomes in Hormone Receptor-Positive, HER2-Negative, Node-Negative Breast Cancer in the Randomized TAILORx Trial. Journal of the National Cancer Institute. 2021 Apr 6;113(4):390-399. PMID: 32986828
  • Schneider BP, Li L, Radovich M, Shen F, Miller KD, Flockhart DA, Jiang G, Vance G, Gardner L, Vatta M, Bai S, Lai D, Koller D, Zhao F, O'Neill A, Smith ML, Railey E, White C, Partridge A, Sparano J, Davidson NE, Foroud T, Sledge GW Jr. Genome-Wide Association Studies for Taxane-Induced Peripheral Neuropathy in ECOG-5103 and ECOG-1199. Clinical cancer research : an official journal of the American Association for Cancer Research. 2015 Nov 15;21(22):5082-5091. Epub 2015 Jul 2. PMID: 26138065
  • Dunsmore VJ, Snyder BS, Gareen IF, Lehman CD, Khan SA, Romanoff J, Gatsonis C, Corsetti RL, Rahbar H, Spell DW, Han LK, Bumberry JR, Miller KD, Sparano JA, Comstock C, Park E, Wagner LI, Carlos RC. Quality of Life Among Patients With Ductal Carcinoma In Situ. JAMA network open. 2025 Jul 1;8(7):e2518887. PMID: 40608342
  • Smith KL, Zhao F, Mayer IA, Tevaarwerk AJ, Garcia SF, Arteaga CL, Symmans WF, Park BH, Burnette BL, Makower DF, Block M, Morley KA, Jani CR, Mescher C, Dewani SJ, Brown-Glaberman U, Flaum LE, Mayer EL, Sikov WM, Rodler ET, DeMichele AM, Sparano JA, Wolff AC, Miller KD, Wagner LI. Adjuvant platinum versus capecitabine for residual, invasive, triple-negative breast cancer: Patient-reported outcomes in ECOG-ACRIN EA1131. Cancer. 2024 May 15;130(10):1747-1757. Epub 2024 Jan 18. PMID: 38236702
  • Mayer IA, Zhao F, Arteaga CL, Symmans WF, Park BH, Burnette BL, Tevaarwerk AJ, Garcia SF, Smith KL, Makower DF, Block M, Morley KA, Jani CR, Mescher C, Dewani SJ, Tawfik B, Flaum LE, Mayer EL, Sikov WM, Rodler ET, Wagner LI, DeMichele AM, Sparano JA, Wolff AC, Miller KD. Reply to T. Shimoi et al and Y. Shimanuki et al. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Nov 1;39(31):3522-3524. Epub 2021 Sep 23. PMID: 34554848
  • Chou SS, Romanoff J, Lehman CD, Khan SA, Carlos R, Badve SS, Xiao J, Corsetti RL, Javid SH, Spell DW, Han LK, Sabol JL, Bumberry JR, Gareen IF, Snyder BS, Gatsonis C, Wagner LI, Wolff AC, Miller KD, Sparano JA, Comstock CE, Rahbar H. Preoperative Breast MRI for Newly Diagnosed Ductal Carcinoma in Situ: Imaging Features and Performance in a Multicenter Setting (ECOG-ACRIN E4112 Trial). Radiology. 2021 Oct;301(1):66-77. Epub 2021 Aug 3. PMID: 34342501
  • Schneider BP, Lai D, Shen F, Jiang G, Radovich M, Li L, Gardner L, Miller KD, O'Neill A, Sparano JA, Xue G, Foroud T, Sledge GW Jr. Charcot-Marie-Tooth gene, SBF2, associated with taxane-induced peripheral neuropathy in African Americans. Oncotarget. 2016 Dec 13;7(50):82244-82253. PMID: 27732968
  • Schneider BP, Shen F, Gardner L, Radovich M, Li L, Miller KD, Jiang G, Lai D, O'Neill A, Sparano JA, Davidson NE, Cameron D, Gradus-Pizlo I, Mastouri RA, Suter TM, Foroud T, Sledge GW Jr. Genome-Wide Association Study for Anthracycline-Induced Congestive Heart Failure. Clinical cancer research : an official journal of the American Association for Cancer Research. 2017 Jan 1;23(1):43-51. Epub 2016 Dec 19. PMID: 27993963
  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. The New England journal of medicine. 2018 Jul 12;379(2):111-121. Epub 2018 Jun 3. PMID: 29860917
  • Yeruva SLH, Zhao F, Miller KD, Tevaarwerk AJ, Wagner LI, Gray RJ, Sparano JA, Connolly RM. E2112: randomized phase iii trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. NPJ breast cancer. 2018 Jan 11;4:1. doi: 10.1038/s41523-017-0053-3. eCollection 2018. PMID: 29354686
  • Solin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2015 Nov 20;33(33):3938-44. Epub 2015 Sep 14. PMID: 26371148
  • Khan SA, Zhao F, Goldstein LJ, Cella D, Basik M, Golshan M, Julian TB, Pockaj BA, Lee CA, Razaq W, Sparano JA, Babiera GV, Dy IA, Jain S, Silverman P, Fisher CS, Tevaarwerk AJ, Wagner LI, Sledge GW. Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108). Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2022 Mar 20;40(9):978-987. Epub 2022 Jan 7. PMID: 34995128
  • Sadigh G, Gray RJ, Sparano JA, Yanez B, Garcia SF, Timsina LR, Sledge GW, Cella D, Wagner LI, Carlos RC. Breast cancer patients' insurance status and residence zip code correlate with early discontinuation of endocrine therapy: An analysis of the ECOG-ACRIN TAILORx trial. Cancer. 2021 Jul 15;127(14):2545-2552. Epub 2021 Apr 1. PMID: 33793979
  • Wagner LI, Gray RJ, Sparano JA, Whelan TJ, Garcia SF, Yanez B, Tevaarwerk AJ, Carlos RC, Albain KS, Olson JA Jr, Goetz MP, Pritchard KI, Hayes DF, Geyer CE, Dees EC, McCaskill-Stevens WJ, Minasian LM, Sledge GW Jr, Cella D. Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020 Jun 10;38(17):1875-1886. Epub 2020 Apr 9. PMID: 32271671
  • Morgans AK, Chen YH, Sweeney CJ, Jarrard DF, Plimack ER, Gartrell BA, Carducci MA, Hussain M, Garcia JA, Cella D, DiPaola RS, Patrick-Miller LJ. Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Apr 10;36(11):1088-1095. Epub 2018 Mar 9. PMID: 29522362
  • Mayer IA, Zhao F, Arteaga CL, Symmans WF, Park BH, Burnette BL, Tevaarwerk AJ, Garcia SF, Smith KL, Makower DF, Block M, Morley KA, Jani CR, Mescher C, Dewani SJ, Tawfik B, Flaum LE, Mayer EL, Sikov WM, Rodler ET, Wagner LI, DeMichele AM, Sparano JA, Wolff AC, Miller KD. Randomized Phase III Postoperative Trial of Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Aug 10;39(23):2539-2551. Epub 2021 Jun 6. PMID: 34092112
  • Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet (London, England). 2016 May 14;387(10032):2008-16. Epub 2016 Mar 9. PMID: 26969090
  • Lehman CD, Gatsonis C, Romanoff J, Khan SA, Carlos R, Solin LJ, Badve S, McCaskill-Stevens W, Corsetti RL, Rahbar H, Spell DW, Blankstein KB, Han LK, Sabol JL, Bumberry JR, Gareen I, Snyder BS, Wagner LI, Miller KD, Sparano JA, Comstock C. Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment. JAMA oncology. 2019 Jul 1;5(7):1036-1042. PMID: 30653209
  • Schneider BP, Shen F, Jiang G, O'Neill A, Radovich M, Li L, Gardner L, Lai D, Foroud T, Sparano JA, Sledge GW Jr, Miller KD. Impact of Genetic Ancestry on Outcomes in ECOG-ACRIN-E5103. JCO precision oncology. 2017;2017. Epub 2017 Aug 21. PMID: 29333527