Phase 3
Completed N=452
A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
Source: ClinicalTrials.gov NCT01026142 ↗Enrolled (actual)
452
Serious AEs
24.9%
Results posted
Oct 2016
Primary outcomePrimary: Progression Free Survival (Independent Assessment) — 9.0; 11.1 months — p=0.0731
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (Independent Assessment) |
9.0; 11.1 | 0.0731 |
| SECONDARY Overall Survival (OS) |
28.1; 37.2 | — |
| SECONDARY Overall Survival (OS) Rate Based on a 2-year Truncated Analysis |
55.0; 74.9 | — |
| SECONDARY Investigator Assessment Progression-Free Survival (PFS) |
9.0; 11.8 | — |
| SECONDARY Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment |
39.0; 50.6 | — |
| SECONDARY Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment |
39.0; 50.9 | — |
| SECONDARY Overall Objective Response Rate (ORR) |
0; 1.8; 32.9; 38.7; 1.2; 6.7 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
54.0; 63.6 | — |
| SECONDARY Duration of Objective Response |
30.0; 51.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult female patients >/=18 years of age
- Metastatic HER2 positive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
- Prior treatment with taxane-containing regimen
- Left ventricular ejection fraction (LVEF) >/=50 percent
- For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
Exclusion Criteria
- Prior treatment with pertuzumab or capecitabine
- Concurrent treatment with other experimental drug
- Concurrent immunotherapy or anticancer hormonal therapy
- Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
- Central nervous system (CNS) metastases, which are not well controlled
- History of exposure to anthracycline cumulative dose equivalent to 360mg/m2
- History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months prior to randomization
- History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
- History of another cancer which could affect compliance or result interpretation
- Inadequate organ function
- Pregnant or breastfeeding women
- life expectancy < 12 weeks
Data sourced from ClinicalTrials.gov (NCT01026142). 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.