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7d
OptiTROP-Breast01: SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
P3, N=254, Active, not recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Trial completion date: Dec 2024 --> Mar 2025
Trial completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 expression • PGR negative • HER-2 negative + HR positive + BRCA mutation
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gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
2ms
Real-world demographics, clinical characteristics, and treatment patterns among US patients with HER2-negative early breast cancer and germline BRCA mutations since 2021 (SABCS 2024)
Pembrolizumab (n=92/151, 61%) and CT (n=54/151, 36%) were the most common neoadjuvant therapies for TNBC. Recently updated cancer guidelines endorse gBRCAm testing in all pts ≤65 years with a breast cancer diagnosis, pts >65 years who are candidates for PARP inhibitor therapy, and other high-risk individuals. This real-world analysis of pts diagnosed since 2021 showed that 55% of pts with HR+/HER2− eBC and 27% with TNBC did not receive a gBRCA test, and utilization of adjuvant olaparib was low, particularly among pts with HR+/HER2− eBC. Wider implementation of genetic testing is needed to ensure appropriate utilization of olaparib in eligible pts with eBC.
Clinical • Real-world evidence • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker • Real-world
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HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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HR positive • HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
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Oncotype DX Breast Recurrence Score®Test
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Keytruda (pembrolizumab) • Lynparza (olaparib)
2ms
BRCA1/2 alterations in circulating tumor DNA: correlation with germline origin and impact on survival in breast cancer. (SABCS 2024)
The VAF cut-off identified for the likelihood of a germinal mutation detected by ctDNA resulted lower than expected, underlining the importance of a larger germline BC screening, with considerable impact on therapeutic decision making and germline testing of other family members. Further analysis to explore the interplay of different co-mutations with BRCA1/2 will be performed and validation in additional dataset is needed.
BRCA Biomarker • PARP Biomarker • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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HER-2 positive • TP53 mutation • BRCA2 mutation • BRCA1 mutation • EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative • BRCA1 mutation + BRCA2 mutation • HER-2 negative + HR positive + BRCA mutation
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Guardant360® CDx
3ms
Trial completion • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • BAP1 (BRCA1 Associated Protein 1) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD50 (RAD50 Double Strand Break Repair Protein) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • FANCF (FA complementation group F) • WRN (WRN RecQ Like Helicase) • FANCM (FA Complementation Group M) • FANCD2 (FA Complementation Group D2) • FANCE (FA Complementation Group E) • FANCC (FA Complementation Group C)
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HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • ATM mutation • PALB2 mutation • CDK12 mutation • BAP1 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • FANCA mutation • HR positive + HER-2 negative • RAD50 mutation • BARD1 mutation • BLM mutation • CHEK1 mutation • FANCF mutation • MRE11A mutation • NBN mutation • FANCM mutation • PTEN mutation + HR positive • CHEK1 expression • HER-2 negative + HR positive + BRCA mutation
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Herceptin (trastuzumab) • Zejula (niraparib) • Puyouheng (pucotenlimab)