Hi needle, the 2019 San Antonio Breast Cancer Symposium on 10-14...

Hi needle, the 2019 San Antonio Breast Cancer Symposium on 10-14 December is huge with about 7500 delegates.
Find below Dr Jose P Leone Abstract Background. I could not find Dr Partick Wen presentation in my search.
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Dec 11 2019 5:00PM OT1-08-05. Phase II trial of GDC-0084 in combination with trastuzumab for patients with HER2-positive breast cancer brain metastases (BCBM)
Session OT1-08 - OT1-08. New Agents and Combinations OT1-08-05. Phase II trial of GDC-0084 in combination with trastuzumab for patients with HER2-positive breast cancer brain metastases (BCBM)
December 11, 2019, 5:00 PM - 7:00 PM Hall 1
Authors Jose P Leone, Lorenzo Trippa, Lindsey Milisits, Chelsea Andrews, Jennifer Ligibel, Heather Parsons, Wenya L Bi, Jean Zhao, Eric P Winer and Nancy U Lin. Dana-Farber Cancer Institute, Boston, MA Disclosures J.P. Leone: Contracted Research (NOTE: Pls must provide disclosure in this category); Author; Kazia Therapeutics. L. Trippa: None. L. Milisits: None. C. Andrews: None. J. Ligibel: None. H. Parsons: None. W.L. Bi: None. J. Zhao: None. E.P. Winer: None. N.U. Lin: None.
Abstract Background: The PI3K/Akt/mTOR is an important pathway in BCBM. Mutations in PIK3CA or PTEN loss are associated with trastuzumab resistance. Inhibition of PI3K and mTOR led to durable responses in 3 of 5 patient-derived xenografts (PDX) models of BCBM. GDC-0084 is a potent, brain-penetrant inhibitor of class I PI3K and mTOR.Methods: This is a single-center, phase II study to evaluate the efficacy of the combination of GDC-0084 with trastuzumab for the treatment of central nervous system (CNS) metastases in patients with HER2-positive breast cancer. Patients will receive GDC-0084 (45 mg daily) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks). Two cohorts will be enrolled: Cohort A: a single-arm, two-stage, phase II cohort; and Cohort B: a pre-surgical window cohort. Inclusion criteria include unequivocal evidence of new and/or progressive HER2-positive CNS metastases, at least one measurable (≥10 mm) CNS metastasis (Cohort A), clinical indication for CNS metastasis resection (Cohort B). Primary endpoint for Cohort A is objective response rate (ORR) in the CNS per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. For Cohort B, the primary endpoint is the correlation between p4EBP1 levels in the resected CNS tumor tissue from patients and intracranial response to GDC-0084/trastuzumab in the PDX model generated from the same patient. Secondary endpoints include overall survival, safety and patient-reported outcomes. Mandatory blood and cerebrospinal fluid with optional tumor biopsy will be collected at baseline, on-treatment and at progression. In Cohort A, we will enroll 37 patients in a Simon two-stage design. If ≥4 responses are seen, the regimen will be considered successful. This design has 90% power with alpha <10%. Cohort B will enroll 10 patients. The trial opened in February, 2019. NCT03765983.

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Jose Pablo Leone, MD, provides an overview of a study of PI3K inhibitor GDC-0084 with trastuzumab in patients with HER2-positive breast cancer that has metastasized to the brain previously on 23 August 2019 via Dana Farber YouTube.



Regards..