A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metatastic Breast Cancer 


Tracking Information

Start Date  ICMJE 
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01026142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 3, 2009)
  • 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 ]
  • Duration of response [ Time Frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Safety, Tolerability; AEs, laboratory parameters [ Time Frame: AEs: throughout study, laboratory assessments: every 3 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metatastic Breast Cancer
Official Title  ICMJEA Multicenter Randomized Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab on Progression Free Survival, as 2nd-line Treatment in Patients With HER2-positive Metastatic Breast Cancer That Has Progressed After Previous Treatment With Trastuzumab.
Brief 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. The target sample size is 450 patients.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBreast Cancer
Intervention  ICMJE
  • Drug: pertuzumab
    pertuzumab 840 mg iv loading, then 420 mg iv every 3 weeks
  • Drug: capecitabine
    capecitabine 1250 mg/m2 (Arm A) 1000 mg/m2 (Arm B) po twice daily for 14 days every 3 weeks
    Other Name: Xeloda
  • Drug: trastuzumab
    trastuzumab 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
    Other Name: Herceptin
Study Arms / Comparison Groups
  • A: Active Comparator
    Interventions:
    • Drug: capecitabine
    • Drug: trastuzumab
  • B: Experimental
    Interventions:
    • Drug: pertuzumab
    • Drug: capecitabine
    • Drug: trastuzumab

Recruitment Information

Estimated Enrollment  ICMJE450
Estimated Completion DateDecember 2015
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult 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 doxorubicin
  • 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
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MO22324888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEAustria,   Belgium,   Canada,   Croatia,   Czech Republic,   Estonia,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Lithuania,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01026142
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMO22324, 2008-006801-17
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche