Back to resultsA Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pyrotinib, Trastuzumab, Docetaxel
Placebo, Trastuzumab, Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- HER2 positive recurrent or metastasis breast cancer.
- Patients with measurable disease are eligible.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
- Adequate organ function.
- Signed, written inform consent obtained prior to any study procedure.
Exclusion Criteria:
- History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
- History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
- Assessed by the investigator to be unable receive systemic chemotherapy.
- History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Sites / Locations
- Cancer Institute and Hospital,Chinese Academy of Medical Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Pyrotinib Plus trastuzumab and docetaxel
Placebo plus trastuzumab and docetaxel
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
AEs+SAEs
Adverse Events and Serious Adverse Events
OS
Overall Survival
ORR
Objective Response Rate
DoR
Duration of Objective Response
CBR
Clinical Benefit rate
Full Information
NCT ID
NCT03863223
First Posted
March 1, 2019
Last Updated
November 21, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03863223
Brief Title
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
Official Title
A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
July 30, 2024 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
590 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Pyrotinib Plus trastuzumab and docetaxel
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo plus trastuzumab and docetaxel
Intervention Type
Drug
Intervention Name(s)
Pyrotinib, Trastuzumab, Docetaxel
Intervention Description
Pyrotinib 400mg orally daily until progressive disease
Intervention Type
Drug
Intervention Name(s)
Placebo, Trastuzumab, Docetaxel
Intervention Description
Placebo 400mg orally daily until progressive disease
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
Approximately 42 months
Secondary Outcome Measure Information:
Title
AEs+SAEs
Description
Adverse Events and Serious Adverse Events
Time Frame
From the first drug administration to within 28 days for the last treatment
Title
OS
Description
Overall Survival
Time Frame
Up to 2 years
Title
ORR
Description
Objective Response Rate
Time Frame
Approximately 42 months
Title
DoR
Description
Duration of Objective Response
Time Frame
Approximately 42 months
Title
CBR
Description
Clinical Benefit rate
Time Frame
From the start of randomization to 6 months
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:
HER2 positive recurrent or metastasis breast cancer.
Patients with measurable disease are eligible.
Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
Adequate organ function.
Signed, written inform consent obtained prior to any study procedure.
Exclusion Criteria:
History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
Assessed by the investigator to be unable receive systemic chemotherapy.
History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Facility Information:
Facility Name
Cancer Institute and Hospital,Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
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