Clinical trial · Interventional
A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Capecitabine + Trastuzumab
- interventionNames
- Drug: Capecitabine
- Drug: Trastuzumab
- type
- EXPERIMENTAL
- label
- B: Capecitabine + Trastuzumab + Pertuzumab
- interventionNames
- Drug: Capecitabine
- Drug: Pertuzumab
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Progression Free Survival (Independent Assessment)
- timeFrame
- Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available