An interventional study of Next Generation Sequencing (NGS) detection in Breast Neoplasm Female, Therapeutics and Mutation, sponsored by Peking Union Medical College. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Peking Union Medical College · Not applicable, Interventional, and Treatment
To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).
Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated treatment plan according to the test results: 1) those with ESR1 mutation and who did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3) those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If the efficacy evaluation is effective, continue the current treatment and re-evaluate the efficacy every two months; if the efficacy evaluation is ineffective (progress), then withdraw from this study. The vital signs, blood routine, liver and kidney functions and imaging examinations were examined at least every two months in the patients in the study group, and the curative effect was evaluated according to RECIST v1.1 standard.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Laboratory criteria:
① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.
② platelet (>100 *109/L); hemoglobin (>10g/dL); serum creatinine (\<1.5 *normal value) upper limit (ULN); aspartate aminotransferase (AST) (\<2.5 *ULN); alanine aminotransferase (ALT) (\<2.5 *ULN); total bilirubin (\<1.5 *ULN); serum creatinine (\<1.5 *ULN);
Exclusion Criteria:
Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.
Diagnostic Test: Next Generation Sequencing (NGS) detection
The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy
Progression-free survival (PFS)
From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first
Time frame: up to 36 months
Overall survival (OS)
Time from first use endocrine treatment to death
Time frame: up to 60 months
Adverse events (AEs)
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Time frame: up to 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College