HER2-positive Breast Cancer, Metastatic Breast Cancer
Conditions
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, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.
Interventions
DRUGTrastuzumab plus chemotherapy
Trastuzumab: 8 mg/kg loading dose followed by 6 mg/kg, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy Experimental: Pyrotinib +Trastuzumab + chemotherapy
DRUGTrastuzumab in combination with pyrotinib plus chemotherapy
Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 and ≤75 years; 2. Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification; 3. History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting; 4. History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting; 5. 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); 6. ECOG performance status of 0 to 1; 7. According to RECIST 1.1, at least one extracranial measurable lesion exists； 8. Signed informed consent.
Exclusion criteria
1. Patients with leptomeningeal metastasis or unstable brain metastasis; 2. History of neurological or psychiatric disorders; 3. Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma; 4. Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery. 5. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 6. History of allergies to the drug components of this regimen; 7. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation; 8. Any other situations judged by investigator as not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | approximately 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | approximately 8 months |
| Adverse Events (AEs) | From the first drug administration to within 28 days for the last treatment |
Countries
China
Outcome results
None listed