Status:
UNKNOWN
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Advanced HR+ HER2 Negative Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 e...
Eligibility Criteria
Inclusion
- 1\) Female patients with advanced breast cancer aged ≥18 years. 2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions.
- ER positivity and/or PR positivity is defined as: the proportion of tumor cells with positive staining accounts for ≥ 10% of all tumor cells (confirmed by the investigator of the trial center);
- HER2 negative is defined as: standard immunohistochemistry (IHC) test is 0/1+; HER2 (2+) needs to be tested by FISH, HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4 (by the test center of the test center) Investigator review and confirmation).
- 3\) CDK4/6 inhibitors combined with endocrine therapy can conduct complete efficacy evaluation and follow-up information collection.
- 4\) Postmenopausal or premenopausal/perimenopausal female patients can be enrolled.
- Postmenopausal status, defined as meeting at least one of the following criteria: prior bilateral ovarian surgery; age ≥60 years; age \<60 years, menopause for at least 12 months (not due to chemotherapy, tamoxifen, toremide) fen or ovarian suppression) and follicle-stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.
- Premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRHa during the study period.
- 5\) According to RECIST 1.1 criteria, patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions.
Exclusion
- 1\) Early breast cancer patients receive CDK4/6 inhibitor drug therapy. 2) HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or positive fluorescence in situ hybridization.
- 3\) Pregnant or lactating female patients. 4) Patients deemed unsuitable for inclusion by the investigator.
Key Trial Info
Start Date :
December 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05295043
Start Date
December 10 2022
End Date
January 1 2024
Last Update
September 29 2022
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