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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 July 12, 2018

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.
Show details

- 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.
Show details

- 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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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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Biological: PF-05280014
    Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
    Other Name: Trastuzumab-Pfizer
  • Drug: Paclitaxel
    A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m^2 and then 60 mg/m^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.
  • Biological: Herceptin®
    Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
    Other Name: Trastuzumab (EU)
  • Experimental: PF-05280014
    Interventions:
    • Biological: PF-05280014
    • Drug: Paclitaxel
  • Active Comparator: Herceptin®
    Interventions:
    • Biological: Herceptin®
    • Drug: Paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
690
February 26, 2019
August 24, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Czechia,   Greece,   Hungary,   India,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Thailand,   Turkey,   Ukraine,   United States
Czech Republic,   Paraguay,   Puerto Rico,   Singapore,   Spain
 
NCT01989676
B3271002
REFLECTIONS B327-02
2013-001352-34 ( EudraCT Number )
B3271002 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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