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

NCT01026142 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2018-08-14

Study results available
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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.

Conditions

Interventions

DRUG

Capecitabine

1000 mg/m2 po twice daily for 14 days every 3 weeks

DRUG

Capecitabine

1250 mg/m2 po twice daily for 14 days every 3 weeks

DRUG

Pertuzumab

840 mg iv loading, then 420 mg iv every 3 weeks

DRUG

Trastuzumab

8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-26
Primary Completion
2015-05-29
Completion
2017-08-07

Countries

  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026142 on ClinicalTrials.gov