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

NCT ID: NCT04842617

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 5274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2031-10-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR6390

Intervention Type: DRUG

SHR6390 combined with endocrine therapy

Treatment group B

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo combined with endocrine therapy

Interventions

SHR6390

SHR6390 combined with endocrine therapy

Intervention Type: DRUG

placebo

placebo combined with endocrine therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR6390-III-303

Identifier Type: -

Identifier Source: org_study_id