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

A Multicenter, Randomized, Double-blind Phase III Study：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
• Intervention / Treatment: Drug: SHR6390; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 5274
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: SHR6390; SHR6390 combined with endocrine therapy
Placebo Comparator: Treatment group B	Drug: placebo; placebo combined with endocrine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IDFS（Invasive Disease-Free Survival）	at least 5 years from the date of randomization .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS(Disease-Free Survival)		The observation time is at least 5 years from the date of randomization . Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
OS(Overall Survival)		up to approximately 5 years.
DDFS(Distant Disease-Free Survival)		from randomization to distant recurrence or death from any cause, whichever occurs first. Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.	To evaluate the safety and tolerability of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.	up to approximately 5 years
Plasma concentration of SHR6390 will be analyzed for PK samples	To explore the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.	collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2031

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: SHR6390-III-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No