Status:
UNKNOWN
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
Lead Sponsor:
Fudan University
Conditions:
HER2-positive Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, tr...
Eligibility Criteria
Inclusion
- Aged ≥18 and ≤75 years;
- Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
- History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
- History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
- Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);
- ECOG performance status of 0 to 1;
- According to RECIST 1.1, at least one extracranial measurable lesion exists；
- Signed informed consent.
Exclusion
- Patients with leptomeningeal metastasis or unstable brain metastasis;
- History of neurological or psychiatric disorders;
- Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
- Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
- Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
- History of allergies to the drug components of this regimen;
- History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
- Any other situations judged by investigator as not suitable for participating in this study.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05346861
Start Date
September 15 2021
End Date
October 31 2024
Last Update
April 26 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032