Phase 3
Completed N=707
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)
Source: ClinicalTrials.gov NCT01989676 ↗Enrolled (actual)
707
Serious AEs
19.4%
Results posted
Jan 2018
Primary outcomePrimary: Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population — 62.5; 66.5 percentage of participants
◆ Published Evidence
Established
60citations · ~9 / year
PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.
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.
Linked Publications (3)
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PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.
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Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin<sup>®</sup>) in patients with HER2-positive metastatic breast cancer.
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Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population |
62.5; 66.5 | — |
| SECONDARY One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population |
12.16; 12.06 | 0.505 |
| SECONDARY Duration of Response (DOR) Per Central Radiology Assessments: ITT Population |
11.27; 10.58 | 0.304 |
| SECONDARY Overall Survival: ITT Population |
NA; NA | 0.339 |
| SECONDARY Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population |
89.85; 95.70 | — |
| SECONDARY Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population |
89.70; 94.40 | — |
| SECONDARY Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population |
0.00; 27.90; 48.20; 53.50; 57.00; 57.40 | — |
| SECONDARY Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population |
0.00; 29.80; 50.40; 54.35; 60.00; 61.20 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population |
30; 14; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population |
20; 9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01989676) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.