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

Primary Purpose

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

Status
Enrolling by invitation
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR6390
placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Arm Description

Outcomes

Primary Outcome Measures

IDFS（Invasive Disease-Free Survival）

Secondary Outcome Measures

DFS(Disease-Free Survival)
OS(Overall Survival)
DDFS(Distant Disease-Free Survival)
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.
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.

Full Information

First Posted
March 30, 2021
Last Updated
May 20, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04842617
Brief Title
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR6390 Tablets compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR6390
Intervention Description
SHR6390 combined with endocrine therapy
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo combined with endocrine therapy
Primary Outcome Measure Information:
Title
IDFS（Invasive Disease-Free Survival）
Time Frame
at least 5 years from the date of randomization .
Secondary Outcome Measure Information:
Title
DFS(Disease-Free Survival)
Time Frame
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.
Title
OS(Overall Survival)
Time Frame
up to approximately 5 years.
Title
DDFS(Distant Disease-Free Survival)
Time Frame
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.
Title
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.
Description
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.
Time Frame
up to approximately 5 years
Title
Plasma concentration of SHR6390 will be analyzed for PK samples
Description
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.
Time Frame
collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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