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)

Pfizer

Status and phase

Completed

Phase 3

Conditions

Metastatic Breast Cancer

Treatments

Biological: PF-05280014

Drug: Paclitaxel

Biological: Herceptin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01989676

2013-001352-34 (EudraCT Number)

B3271002 (Other Identifier)

REFLECTIONS B327-02

Details and patient eligibility

About

The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.

Enrollment

707 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.