Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments capecitabine [xeloda], pertuzumab, trastuzumab [herceptin]
Phase phase 3
Targets HER, HER2
Sponsor Hoffmann-La Roche
Start date January 2010
End date May 2015
Trial size 452 participants
Trial identifier NCT01026142, 2008-006801-17, MO22324

Summary

This randomized, two-arm study will evaluate the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with HER2-positive metastatic breast cancer. The study population consists of female patients, whose disease has progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B are to receive trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter). Patients in Arm A and Arm B are to receive 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 will receive pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment is to continue until disease progression or unacceptable toxicity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
capecitabine [xeloda]
1250 mg/m2 po twice daily for 14 days every 3 weeks
trastuzumab [herceptin]
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
(Experimental)
capecitabine [xeloda]
1000 mg/m2 po twice daily for 14 days every 3 weeks
pertuzumab
840 mg iv loading, then 420 mg iv every 3 weeks
trastuzumab [herceptin]
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

Primary Outcomes

Measure
Progression free survival (Independent assessment)
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter

Secondary Outcomes

Measure
Overall Survival based on a 2-year truncated analysis
time frame: From randomization until death from any cause
Progression free survival (investigator assessment)
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Time to progression
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Time to treatment failure
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Overall objective response
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Clinical benefit rate
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Overall Survival
time frame: From randomization until death from any cause
Safety, Tolerability; AEs, laboratory parameters
time frame: AEs: from screening until 2 years after last dose of study drug. Laboratory assessments: every 3 weeks
Duration of response
time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Adult female patients >/=18 years of age - Metastatic HER2 positive breast cancer - 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 - 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) - 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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.