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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)

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01989676
Pfizer
Active, not recruiting
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)

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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