Health Condition 1: null- Metastatic Breast Cancer
Conditions
Interventions
Intervention1: PF-05280014: On treatment days when both PF-05280014 and paclitaxel are administered, the order of administration should be PF-05280014 infusion, followed by paclitaxel infusion.
Durin
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Female patients aged 18 years or older. •Histologically confirmed diagnosis of breast cancer. •Presence of metastatic disease. •Prior documentation of HER2 gene amplification or overexpression. Determination of HER2 positive status using one of the Sponsor accepted analytical test. •Available tumor tissue for central review of HER2 status. •At least 1 measurable lesion as defined by RECIST 1.1. •Eastern Cooperative Oncology Group status of 0 to 2. •Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.
Exclusion criteria
Exclusion criteria: •Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment. •Prior systemic therapy for metastatic disease (except endocrine therapy). •Prior cumulative dose of doxorubicin of more than 400 mg per m2, epirubicin dose more than 800 mg per m2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mgper m2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg per m2 of doxorubicin. •Inflammatory breast cancer. •Active uncontrolled or symptomatic central nervous system metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Objective Response Rate (ORR) The percent of patients within each treatment group that achieved Complete Response (CR) or Partial Response (PR) by Week 25 of the study (window ± 14 days) and confirmed on a follow-up assessment, in accordance with the RECIST 1.1. Timepoint: Week 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year Progression-Free Survival (PFS) Rate The time from date of randomization to first progression of disease (PD) or death due to any cause in the absence of documented PD. Timepoint: up to 12 months;1-year Survival Rate Time from date of randomization to death due to any cause while the patient is on the study. Timepoint: up to 12 months;Duration of Response (DOR) The time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Progressive Disease (PD) or to death due to any cause in the absence of documented PD. Timepoint: up to 12 months;Incidence of ADA The percentage of patients with positive ADA and neutralizing antibodies will be summarized for each treatment arm. Timepoint: up to 24 months;Maximum Observed Plasma Concentration (Cmax) Peak PF-05280014 and trastuzumab-EU concentrations at selected cycles. Timepoint: up to 4 months;Minimum Observed Plasma Trough Concentration (Cmin) Trough PF-05280014 and trastuzumab-EU concentrations at selected cycles. Timepoint: up to 24 months | — |
Countries
Argentina, Brazil, Chile, Czech Republic, Greece, Hungary, India, Japan, Mexico, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed