Status:
ACTIVE_NOT_RECRUITING
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative. To observe the...
Eligibility Criteria
Inclusion
- Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old.
- Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-.
- Underwent radical resection of breast cancer.
- The score of ECOG was 0 - 1.
- Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures.
- With my consent and informed consent, I am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures.
Exclusion
- This Pathological examination diagnosed as HER2-positive breast cancer.
- The history of any malignant tumor other than breast cancer within 5 years before randomization.
- At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.).
- In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc
- Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
- There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2031
Estimated Enrollment :
5274 Patients enrolled
Trial Details
Trial ID
NCT04842617
Start Date
April 30 2021
End Date
October 31 2031
Last Update
August 1 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032