A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

• Status: Completed
• Trial end date: 2017-08-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Pertuzumab; Trastuzumab

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