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Phase 3
18 Years
75 Years
Open (Enrolling)
Breast Cancer, Metastases

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Trial Information

Inclusion Criteria:

(main conditions)

- Female patients 18 to 75 years of age with metastatic breast cancer
histologically/cytologically confirmed not amenable to curative surgery or
radiotherapy and who have received at least two prior chemotherapy regimens including
anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate
for these drugs,

- Karnofsky performance score of at least 70 %, adequate haematological, hepatic and
renal functions and ECG without clinically relevant abnormality.

Exclusion Criteria:

- Concurrent serious uncontrolled medical disorder,

- known or clinical evidence of brain metastases or leptomeningeal involvement,

- pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,

- history of second primary malignancy,

- HIV infection, preexisting neuropathy,

- pregnancy or breast feeding.

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

monthly for 6 months after disease progression and then every 3 months

Safety Issue:



Austria: Federal Office for Safety in Health Care

Study ID:

L00070 IN 308 B0



Start Date:

September 2009

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Metastases
  • Breast Neoplasms
  • Neoplasm Metastasis