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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (Independent assessment)

Outcome Time Frame:

Tumour Assessment every 9 weeks until week 27, then every 12 weeks thereafter

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Austria: Federal Agency for Safety in Health Care, Vienna

Study ID:

MO22324

NCT ID:

NCT01026142

Start Date:

January 2010

Completion Date:

August 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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