Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007744

Trial Description

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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)

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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.

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Brief Summary in Scientific Language

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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 
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: capecitabine [Xeloda]
  •   Drug: capecitabine [Xeloda]
  •   Drug: pertuzumab
  •   Drug: trastuzumab [Herceptin]
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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

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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

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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
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Locations of Recruitment

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Recruitment

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  •   2010/01/31
  •   452
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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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

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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

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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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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2015/01/22
* This entry means the parameter is not applicable or has not been set.