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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01026142
First received: November 27, 2009
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This randomized, two-arm study will evaluate the efficacy and safety of a combin ation of trastuzumab and capecitabine with or without pertuzumab in patients wit h HER2-positive metastatic breast cancer. The study population consists of femal e patients, whose disease has progressed during or following previous trastuzuma b 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 there after). 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 treatmen t is to continue until disease progression or unacceptable toxicity.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine [Xeloda]
Drug: pertuzumab
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression free survival (Independent assessment) [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, Tolerability; AEs, laboratory parameters [ Time Frame: AEs: from screening until 2 years after last dose of study drug. Laboratory assessments: every 3 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Overall Survival based on a 2-year truncated analysis [ Time Frame: From randomization until death from any cause ] [ Designated as safety issue: No ]
  • Progression free survival (investigator assessment) [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Overall objective response [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From randomization until death from any cause ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: January 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: capecitabine [Xeloda]
1250 mg/m2 po twice daily for 14 days every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Experimental: B Drug: capecitabine [Xeloda]
1000 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 [Herceptin]
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026142

  Show 185 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01026142     History of Changes
Other Study ID Numbers: MO22324, 2008-006801-17
Study First Received: November 27, 2009
Last Updated: October 20, 2014
Health Authority: Austria: Federal Agency for Safety in Health Care, Vienna

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Pertuzumab
Trastuzumab
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014