A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metatastic Breast Cancer
Tracking InformationStart Date ICMJE | |
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Primary Completion Date | |
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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 ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT01026142 on ClinicalTrials.gov Archive Site |
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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 ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metatastic Breast Cancer |
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Official Title ICMJE | A 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. |
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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. |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Breast Cancer |
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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
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Study Arms / Comparison Groups | - A: Active Comparator
Interventions: - Drug: capecitabine
- Drug: trastuzumab
- B: Experimental
Interventions: - Drug: pertuzumab
- Drug: capecitabine
- Drug: trastuzumab
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Recruitment InformationEstimated Enrollment ICMJE | 450 |
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Estimated Completion Date | December 2015 |
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Primary Completion Date | |
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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
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Gender | Female |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | Austria, Belgium, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hong Kong, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Russian Federation, Spain, Switzerland, Thailand, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT01026142 |
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Responsible Party | Disclosures Group, Hoffmann-La Roche |
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Study ID Numbers ICMJE | MO22324, 2008-006801-17 |
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Study Sponsor ICMJE | Hoffmann-La Roche |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Clinical Trials | Hoffmann-La Roche | |
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Information Provided By | Hoffmann-La Roche |
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