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)
NCT01989676
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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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | 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) | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Metastatic Breast Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 707 | ||||||
Original Estimated Enrollment ICMJE | 690 | ||||||
Actual Study Completion Date ICMJE | June 27, 2020 | ||||||
Actual Primary Completion Date | August 24, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | 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 | ||||||
Removed Location Countries | Czech Republic, Paraguay, Puerto Rico, Singapore, Spain | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01989676 | ||||||
Other Study ID Numbers ICMJE | B3271002 REFLECTIONS B327-02 2013-001352-34 ( EudraCT Number ) B3271002 ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |