- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255523
Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
A Single Arm,Multicenter,Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age:18-75 years old, female;
- HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
- Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy greater than or equal to 6 months;
- The main organs function well, and the inspection indicators meet the following requirements:
1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases; TBIL≤1.5×ULN; Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.
Exclusion Criteria:
- Patients with brain metastases by CT or MRI;
- More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
- Study drug and excipient allergy;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Pregnant or lactating female patients;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Pyrotinib:400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle.
|
After 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of first progression with brain metastases
Time Frame: 24 month
|
Incidence of first progression with brain metastases
|
24 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR without CNS
Time Frame: 24 month
|
Baseline to measured stable disease without central nervous system
|
24 month
|
TTBM
Time Frame: 24 month
|
Time to brain metastases
|
24 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Advanced Breast Cancer
-
Abramson Cancer Center at Penn MedicineActive, not recruitingAdvanced Breast Cancer | Metastatic Breast Cancer | BRCA1 Mutation | BRCA2 Mutation | Locally Advanced Breast CancerUnited States
-
AstraZenecaCompletedAdvanced or Metastatic Breast Cancer | ER+ve Advanced or Metastatic Breast CancerCanada, France, Korea, Republic of, Czechia, Peru, United Kingdom, Spain, Japan, Mexico, Singapore, Bulgaria
-
Zhejiang Cancer HospitalJiangsu Hengrui Pharmaceutical Co., Ltd.Not yet recruitingFemale Breast Cancer Patients | Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer | HRD Positive Advanced Breast Cancer
-
Puma Biotechnology, Inc.CompletedBreast Neoplasms | Advanced Breast Cancer | Advanced Malignant Solid TumorsUnited States, Belgium, China, Hong Kong, Canada, Korea, Republic of, India, Poland, Ukraine
-
Introgen TherapeuticsCompletedLocally Advanced Breast Cancer (LABC)United States
-
University of UtahCelgene CorporationCompletedAdvanced or Metastatic Solid Tumors | Advanced or Metastatic Breast CancerUnited States
-
University Hospital TuebingenRecruitingAdvanced/Metastatic Breast Cancer | Breast Cancer (Early Breast Cancer)Germany
-
Royal Marsden NHS Foundation TrustPfizer; Hoffmann-La RocheRecruitingAdvanced Breast Cancer | Metastatic Breast Cancer | ER+ Breast CancerUnited Kingdom
-
NBE-Therapeutics AGCmed Clinical ServicesTerminatedTriple Negative Breast Cancer | Advanced Solid Tumor | Advanced CancerUnited States
-
Hoffmann-La RocheWithdrawnBreast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Clinical Trials on pyrotinib
-
Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingHER2-positive Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesCompleted
-
Peking Union Medical CollegeUnknownBreast Cancer | HER2 Gene MutationChina
-
Tongji UniversityUnknownNon-small Cell Lung CancerChina
-
Tianjin Medical University Cancer Institute and...UnknownNon Small Cell Lung CancerChina
-
Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Active, not recruitingMetastatic Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.UnknownNon Small Cell LungChina
-
RemeGen Co., Ltd.Not yet recruitingNon-small Cell Lung CancerChina
-
Second Affiliated Hospital, School of Medicine,...Zhejiang Cancer Hospital; First Affiliated Hospital of Zhejiang University; Sir... and other collaboratorsUnknownColorectal CancerChina
-
The First Affiliated Hospital with Nanjing Medical...First Affiliated Hospital of Wenzhou Medical UniversityRecruiting