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)
Completed · Phase 3
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01989676
- Run by
- Pfizer
- People needed
- 707
- Starts
- 2014-02-24
- Expected to finish
- 2020-06-27
- Last updated by the study team
- 2021-07-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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.
Where it is running
- Cancer Center of Central Connecticut — Southington, Connecticut, United States
- Florida Cancer Research Institute — Boca Raton, Florida, United States
- Florida Cancer Research Institute — Plantation, Florida, United States
- COIBA - Centro de Oncologia e Investigacion Buenos Aires — Berazategui, Buenos Aires, Argentina
- Instituto De Oncologia De Rosario — Rosario, Santa Fe Province, Argentina
- Centro Medico San Roque — San Miguel de Tucumán, Tucumán Province, Argentina
- Sanatorio de la Providencia — C.a.b.a, Argentina
- CRIO - Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil
- Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge — Goiânia, Goiás, Brazil
- Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
- Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL — Londrina, Paraná, Brazil
- Associacao Hospital de Caridade Ijui — Ijuí, Rio Grande do Sul, Brazil
- Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado) — Lajeado, Rio Grande do Sul, Brazil
- Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia — Porto Alegre, Rio Grande do Sul, Brazil
- Centro de Pesquisas Oncologicas de Santa Catarina - CEPON — Florianópolis, Santa Catarina, Brazil
- Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral — Itajaí, Santa Catarina, Brazil
- Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral — Itajaí, Santa Catarina, Brazil
- Fundacao Pio XII - Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC — Santo André, São Paulo, Brazil
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC — Santo André, São Paulo, Brazil
- Clinica Alemana de Temuco — Temuco, Araucania, Chile
- Centro de Investigacion Clinica SIM — Temuco, Araucania, Chile
- Administrative office — Temuco, Araucania, Chile
- Fresenius Kabi Chile Therapia iv — Santiago, RM, Chile
- Cancer Center of Central Connecticut — Plainville, Connecticut, United States
Full record on ClinicalTrials.gov
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