Status:
UNKNOWN
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
Lead Sponsor:
Peking Union Medical College
Conditions:
Breast Neoplasm Female
Therapeutics
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 fulvestr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03786575
Start Date
December 1 2018
End Date
December 31 2021
Last Update
June 20 2019
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China