Status:
UNKNOWN
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
Lead Sponsor:
Fuzhou General Hospital
Conditions:
Breast Cancer Female
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human...
Detailed Description
This is a exploratory, single-arm, open-label,multicenter phase II trial. Our primary purpose is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive and hormone re...
Eligibility Criteria
Inclusion
- Age≥18 years,≤70 years, female;
- Postmenopausal or pre-menopausal with ovarian function suppression;
- with or without measurable lesion evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1;
- Metastatic or inoperable local advanced Invasive breast cancer;
- HER2-positive breast cancer;
- HR-positive breast cancer;
- LVEF ≥55%;QT interva\<470 ms;
- Eastern Cooperative Oncology Group(ECOG) scale 0-1;
- Life expectancy ≥3 months;
Exclusion
- Previous systemic non-hormonal anticancer therapy in the metastatic or advanced breast cancer setting;
- Received endocrine therapy within 7 days before randomization;Uncontrolled central nervous system metastases;
- Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months.
- Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
- Severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease, which leading to a clinical indication for chemotherapy.
- History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia);
- History of myocardial infarction within 6 months of randomization;
- History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy;
- Pregnant or lactating women;
- QT interval\>470 ms;
- Serious concomitant diseases (including severe hypertension, severe diabetes, active infection, thyroid disease, etc.) that are harmful to the patient's safety or affect the patient's completion of the study;
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04088110
Start Date
November 1 2019
End Date
November 1 2023
Last Update
September 12 2019
Active Locations (1)
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1
Fuzhou general hospital
Fuzhou, Fujian, China, 365000