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

NCT04842617 | Active Not Recruiting Phase 3

• 1 other identifier: SHR6390-III-303
• Study Type: interventional
• Target: 5,274
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• IDFS（Invasive Disease-Free Survival）

  at least 5 years from the date of randomization .

Secondary Outcomes (5)

• 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.

  up to approximately 5 years

• Plasma concentration of SHR6390 will be analyzed for PK samples

  collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR6390

Treatment group B

PLACEBO COMPARATOR

Drug: placebo

Interventions

SHR6390 DRUG

SHR6390 combined with endocrine therapy

Treatment group A

placebo DRUG

placebo combined with endocrine therapy

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR6390 Tablets compared with placebo

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 13, 2021
• Study Start: April 30, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2031
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)