Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00007744
Trial Description
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 Acronym
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URL of the Trial
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Brief Summary in Lay Language
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.
Brief Summary in Scientific Language
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Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00007744
- 2015/02/18
- 2009/11/27
- no
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Secondary IDs
- 2008-006801-17
- NCT01026142 (ClinicalTrials.gov)
- MO22324 (Hoffmann-La Roche)
- 2008-006801-17
Health Condition or Problem studied
- Breast Cancer
- C50 - Malignant neoplasm of breast
Interventions/Observational Groups
- Drug: capecitabine [Xeloda]
- Drug: capecitabine [Xeloda]
- Drug: pertuzumab
- Drug: trastuzumab [Herceptin]
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control
- Treatment
- Parallel
- III
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Primary Outcome
- Progression free survival (Independent assessment); time frame: Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter
Secondary Outcome
- 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
- 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
Countries of Recruitment
- Argentina
- Austria
- Belgium
- Brazil
- Canada
- Croatia
- Czech Republic
- Estonia
- France
- Germany
- Hong Kong
- Hungary
- Italy
- Korea, Republic of
- Mexico
- Netherlands
- Peru
- Poland
- Romania
- Russian Federation
- Spain
- Thailand
- United Kingdom
Locations of Recruitment
Recruitment
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- 2010/01/31
- 452
- Multicenter trial
- International
Inclusion Criteria
- Female
- 18 Years
- no maximum age
Additional 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
Addresses
-
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- Hoffmann-La Roche
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- Hoffmann-La Roche
- Clinical Trials
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- Hoffmann-La Roche
- Clinical Trials
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Sources of Monetary or Material Support
-
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status
- Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents
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- 3
- 2015/01/22