Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
Breast Neoplasm Female, Therapeutics, Mutation
About this trial
This is an interventional treatment trial for Breast Neoplasm Female focused on measuring Breast Neoplasm, Next Generation Sequencing, Endocrine Therapy
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years, female;
- Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer;
- According to RECIST standard, lesions can be measured (primary lesion length > 1.0 cm or lymph node diameter > 1.5 cm);
- Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy;
- No visceral crisis;
- ECOG PS score: 0-2 points;
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);
- the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion Criteria:
- Pregnant or lactation woman
- With mental disease
- With severe infection or active gastrointestinal ulcers
- With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- taking part or participating in other clinical trials within one month.
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Experimental
NGS detection group
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.