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Phase 3
21 Years
Open (Enrolling)
Advanced Breast Cancer

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Trial Information

Inclusion Criteria:

- female patients

- 21 years of age or older

- histologically/cytologically confirmed carcinoma of the breast

- documented locally recurrent or metastatic disease not amenable to curative surgery
or radiotherapy

- either one, two or three prior chemotherapy regimens

- prior treatments including both an anthracycline and a taxane and patient no longer
candidate for these drugs

- measurable or non-measurable disease according to RECIST 1.1

- Karnofsky performance score of at least 70 %

- adequate haematological, hepatic and renal functions

- ECG without clinically relevant abnormality

Exclusion Criteria:

- known or clinical evidence of brain metastasis or leptomeningeal involvement

- pulmonary lymphangitis or symptomatic pleural effusion

- any serious, concurrent uncontrolled medical disorder

- history of second primary malignancy

- preexisting motor/sensory peripheral neuropathy

- known history of HIV infection

- prior therapy with capecitabine and/or vinca-alkaloids

- history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or
contra indication to any of these drugs

- known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency

- 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:

Progression Free Survival

Outcome Time Frame:

Every 6 weeks

Safety Issue:



Bulgaria: Bulgarian Drug Agency

Study ID:

L00070 IN 305 B0



Start Date:

May 2009

Completion Date:

April 2013

Related Keywords:

  • Advanced Breast Cancer
  • Breast Neoplasms