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

Roche

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab

Drug: Pertuzumab

Drug: Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026142

2008-006801-17 (EudraCT Number)

MO22324

Details and patient eligibility

About

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.

Enrollment

452 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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