Metastatic Breast Cancer
Conditions
Brief summary
This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Interventions
DRUGCapecitabine and Pyrotinib
Pyrotinib 400mg orally daily until progressive disease
DRUGCapecitabine,Trastuzumab, and Pertuzumab
as instruction
Sponsors
Shandong Cancer Hospital and Institute
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
* HER2 positive recurrent or metastasis breast cancer. * Patients with measurable disease are eligible. * Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. * Adequate organ function. * Signed, written inform consent obtained prior to any study procedure.
Exclusion criteria
* History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）. * History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting. * Assessed by the investigator to be unable receive systemic chemotherapy. * History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. * Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | Approximately 42 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | From the first drug administration to within 28 days for the last treatment | AEs+SAEs |
| Overall Survival | Up to 2 years | — |
| Objective Response Rate | Approximately 42 months | — |
| Duration of Objective Response | Approximately 42 months | — |
| Clinical Benefit rate | From the start of randomization to 6 months | — |
Outcome results
None listed