🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04842617
Active, not recruiting Phase 3

Phase III Study :SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative

NCT04842617 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 3
Started
2021-04-30
Last updated
2024-08-01

Condition(s) studied

Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage,Female Breast Cancer

Investigational drug(s) / intervention(s)

SHR6390 →placebo

SHR6390: SHR6390 combined with endocrine therapy

placebo: placebo combined with endocrine therapy

Study 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 PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old. 2. Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-. 3. Underwent radical resection of breast cancer. 4. The score of ECOG was 0 - 1. 5. Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures. 6. 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 Criteria: 1. This Pathological examination diagnosed as HER2-positive breast cancer. 2. The history of any malignant tumor other than breast cancer within 5 years before randomization. 3. At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.). 4. In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc 5. Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug. 6. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04842617 on ClinicalTrials.gov ↗ ← All trials in China