HER2-positive Breast Cancer
Conditions
Brief summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Interventions
DRUGPyrotinib
pyrotinib: 400mg orally daily;
DRUGPlacebo Oral Tablet
placebo: 400mg orally daily;
DRUGTrastuzumab
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
DRUGDocetaxel
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* female patients, 18 years ≤ age ≤ 75 years； * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter * HER2 positive (HER2+++ by IHC or FISH+) * Known hormone receptor status. * Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO * Signed informed consent form (ICF)
Exclusion criteria
* metastatic disease (Stage IV) or inflammatory breast cancer * Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. * clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * Unable or unwilling to swallow tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites | Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days) |
| Event-free survival(EFS) | Following surgery until Year 3 |
| Disease-free Survival (DFS) | Following surgery until Year 3 |
| Distance Disease-free Survival (DDFS) | Following surgery until Year 3 |
| Objective Response Rate (ORR) during neoadjuvant period | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
Countries
China
Outcome results
None listed