Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the First-line Treatment of Advanced HER2-positive/HR-positive Breast Cancer Phase II Study
1 other identifier
interventional
77
1 country
1
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 epidermal growth factor receptor 2) + MBC and inoperable LABC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedSeptember 12, 2019
September 1, 2019
2 years
September 11, 2019
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
From randomization to 36 month
Secondary Outcomes (3)
Objective Overall Response Rate (ORR)
From randomization to 36 month
Duration of Response (DoR)
From randomization to 36 month
Overall Survival (OS)
From randomization to 36 month
Study Arms (1)
Pyrotinib and trastuzumab plus aromatase inhibito
EXPERIMENTALParticipants will receive pyrotinib in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Interventions
Pyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle.
Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses).
The investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuzhou general hospital
Fuzhou, Fujian, 365000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chen Xi, PhD
Fuzhou General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
September 12, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2023
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share