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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

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

Treatments: Drug: placebo; Drug: SHR6390

Study type: Interventional

Funder types: Industry

Identifiers

NCT04842617

SHR6390-III-303

Details and patient eligibility

About

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.

Enrollment: 5,274 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,274 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: SHR6390

Treatment group B

Placebo Comparator group

Treatment:

Drug: placebo