Back to resultsCapecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capecitabine and Pyrotinib
Capecitabine,Trastuzumab, and Pertuzumab
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Adverse Events and Serious Adverse Events
AEs+SAEs
Overall Survival
Objective Response Rate
Duration of Objective Response
Clinical Benefit rate
Full Information
NCT ID
NCT04246502
First Posted
January 28, 2020
Last Updated
January 30, 2020
Sponsor
Shandong Cancer Hospital and Institute
1. Study Identification
Unique Protocol Identification Number
NCT04246502
Brief Title
Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Official Title
A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute
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
This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Capecitabine and Pyrotinib
Intervention Description
Pyrotinib 400mg orally daily until progressive disease
Intervention Type
Drug
Intervention Name(s)
Capecitabine,Trastuzumab, and Pertuzumab
Intervention Description
as instruction
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Approximately 42 months
Secondary Outcome Measure Information:
Title
Adverse Events and Serious Adverse Events
Description
AEs+SAEs
Time Frame
From the first drug administration to within 28 days for the last treatment
Title
Overall Survival
Time Frame
Up to 2 years
Title
Objective Response Rate
Time Frame
Approximately 42 months
Title
Duration of Objective Response
Time Frame
Approximately 42 months
Title
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.
12. IPD Sharing Statement
Learn more about this trial
Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
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