Journal: Nature Communications

Article Title: AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

doi: 10.1038/s41467-022-31668-8

Figure Lengend Snippet: Demographic and patient characteristics at baseline in Parts A and B (safety populations) and the biomarker population (Parts A and B excluding the amcenestrant QD 20-mg dose).

Article Snippet: Wild-type and mutant ESR1 status in cfDNA was determined by ddPCR detecting 12 ESR1 pathogenic single-nucleotide variants in the ligand-binding domain of ESR1 using the OncoBEAMTM platform by Sysmex Inostics (Baltimore, MD, USA) .

Techniques: Biomarker Discovery

Journal: Nature Communications

Article Title: AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

doi: 10.1038/s41467-022-31668-8

Figure Lengend Snippet: Prespecified analyses of antitumor activity in the response-evaluable populations of Parts A and B.

Article Snippet: Wild-type and mutant ESR1 status in cfDNA was determined by ddPCR detecting 12 ESR1 pathogenic single-nucleotide variants in the ligand-binding domain of ESR1 using the OncoBEAMTM platform by Sysmex Inostics (Baltimore, MD, USA) .

Techniques: Activity Assay

Journal: Nature Communications

Article Title: AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

doi: 10.1038/s41467-022-31668-8

Figure Lengend Snippet: Changes from screening to cycle 2, day 28 in a ER nucleus H-score by IHC; b PgR nucleus H-score by IHC; c percent of positive cells showing Ki67 protein expression by IHC; and d ER activation scores by GSVA; and changes from cycle 1, day 1 to cycle 2, day 28 in e allele frequency of ESR1 mutations in cfDNA by ddPCR; and f numbers of ESR1 mutations in cfDNA by ddPCR. *Each line refers to an ESR1 mutation, but several lines may refer to a single patient. C1D1, cycle 1, day 1; C1D15, cycle 1, day 15; C2D28, cycle 2, day 28; CB clinical benefit (complete response + partial response + stable disease ≥ 24 weeks), cfDNA circulating free DNA, ddPC, droplet digital polymerase chain reaction, ER estrogen receptor, ESR1 estrogen receptor 1, GSVA gene set variation analysis, IHC immunohistochemistry, PgR progesterone receptor, PR partial response.

Article Snippet: Wild-type and mutant ESR1 status in cfDNA was determined by ddPCR detecting 12 ESR1 pathogenic single-nucleotide variants in the ligand-binding domain of ESR1 using the OncoBEAMTM platform by Sysmex Inostics (Baltimore, MD, USA) .

Techniques: Expressing, Activation Assay, Mutagenesis, Digital PCR, Immunohistochemistry

Journal: Nature Communications

Article Title: AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

doi: 10.1038/s41467-022-31668-8

Figure Lengend Snippet: ESR1 mutation status at baseline in patients from the biomarker population (Parts A and B excluding the pharmacodynamically inactive amcenestrant QD 20-mg dose) with available data for baseline ESR1 mutational analysis in cfDNA detected by ddPCR ( n = 58), and analyzed by those who subsequently achieved clinical benefit versus no benefit during amcenestrant therapy.

Article Snippet: Wild-type and mutant ESR1 status in cfDNA was determined by ddPCR detecting 12 ESR1 pathogenic single-nucleotide variants in the ligand-binding domain of ESR1 using the OncoBEAMTM platform by Sysmex Inostics (Baltimore, MD, USA) .

Techniques: Mutagenesis, Biomarker Discovery