Phase III Study ：SHR6390/Placebo Combined With Endocrine... | NCT04842617

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

NCT04842617

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Aug 1, 2024Actual

Enrollment

5,274Actual

Phase

Phase 3

Conditions

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

Interventions

SHR6390
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2021Actual

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Oct 31, 2031Estimated

First Submitted Date

Mar 30, 2021

First Submission Date that Met QC Criteria

Apr 12, 2021

First Posted Date

Apr 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5,274Actual

Label	Type	Description	Intervention Names
Treatment group A	Experimental		Drug: SHR6390
Treatment group B	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
SHR6390	Drug	SHR6390 combined with endocrine therapy	Treatment group A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided