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)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:February 24, 2014
End Date:June 30, 2020

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A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER

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.


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.
We found this trial at
5
sites
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Berazategui,
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Boca Raton, Florida 33428
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Plainville, Connecticut
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Plainville, CT
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Plantation, Florida
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Plantation, FL
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Southington, Connecticut 06489
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Southington, CT
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