Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: 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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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

DRKS-ID: DRKS00007744
Date of Registration in DRKS: 2015/02/18
Date of Registration in Partner Registry or other Primary Registry: 2009/11/27
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2008-006801-17
Primary Registry-ID: NCT01026142 (ClinicalTrials.gov)
Sponsor-ID: MO22324 (Hoffmann-La Roche)
Other Secondary-ID: 2008-006801-17

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Health Condition or Problem studied

Free text: Breast Cancer
ICD10: C50 - Malignant neoplasm of breast

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Interventions/Observational Groups

Arm 1: Drug: capecitabine [Xeloda]
Arm 2: Drug: capecitabine [Xeloda]
Arm 3: Drug: pertuzumab
Arm 4: Drug: trastuzumab [Herceptin]

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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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

AR: Argentina
AT: Austria
BE: Belgium
BR: Brazil
CA: Canada
HR: Croatia
CZ: Czech Republic
EE: Estonia
FR: France
DE: Germany
HK: Hong Kong
HU: Hungary
IT: Italy
KR: Korea, Republic of
MX: Mexico
NL: Netherlands
PE: Peru
PL: Poland
RO: Romania
RU: Russian Federation
ES: Spain
TH: Thailand
UK: United Kingdom

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Locations of Recruitment

Berlin
Bremen
Böblingen
Darmstadt
Dortmund
Essen
Frankfurt
Fulda
Hamburg
Hamburg
Hannover
Hannover
Karlsruhe
Kiel
Koblenz
Koeln
Lübeck
Mainz
München
Münster
Offenburg
Recklinghausen
Stendal
Trier
Weinheim

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2010/01/31
Target Sample Size: 452
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Hoffmann-La Roche
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Hoffmann-La Roche
- Clinical Trials
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Hoffmann-La Roche
- Clinical Trials
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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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 .

Translation on version: 3
Last processed date by ClinicalTrials.gov: 2015/01/22

* This entry means the parameter is not applicable or has not been set.