Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer
May 19, 2021 updated by: The First Affiliated Hospital with Nanjing Medical University
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study
This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
Study Overview
Detailed Description
HER2-positive breast cancers account for 15%-20% of all breast cancers.
The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients.
Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial.
This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China
- Jiangsu Provincial People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
HER2-positive metastatic breast cancer patients who failed by lapatinib received pyrotinib
Description
Inclusion Criteria:
- Female and 18-70 years old
- Metastatic or locally recurrent HER2-positive breast cancer
- Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis
- Complete and accurate medical data
Exclusion Criteria:
- Incomplete medical data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Observational Group
Patients receive pyrotinib-based therapy after lapatinib progression.
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Pyrotinib-based therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival (PFS)
Time Frame: 2 years
|
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression.
Patients alive without disease progression are censored at the date of last disease evaluation.
Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Equivocal progression of non-target lesions also qualifies as PD.
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2 years
|
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Objective Response Rate (ORR)
Time Frame: 2 years
|
The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Number of Participants Who Experienced Adverse Events (AE)
Time Frame: 2 years
|
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry).
AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
August 1, 2020
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 19, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POLAR-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.