Clareo Health | A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed diagnosis of breast cancer.
Presence of metastatic disease.
Documentation of HER2 gene amplification or overexpression.
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.
You may not be if
Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.
Prior systemic therapy for metastatic disease (except endocrine therapy).
Prior cumulative dose of doxorubicin of \>400 mg/m2, epirubicin dose \>800 mg/m\^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m\^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m\^2 of doxorubicin.
Inflammatory breast cancer.
Active uncontrolled or symptomatic central nervous system metastases.
