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Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients


Inclusion Criteria:

- Written informed consent.

- Able to comply with the protocol.

- ECOG Performance status 0 - 2.

- Life expectancy more than 12 weeks.

- Known ER / PR status.

- Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or
non-measurable locally recurrent or metastatic disease, who are candidates for

- Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of
chemotherapy was applied more than 6 months prior to randomization.

- Previous adjuvant radiotherapy is allowed as part of the treatment of early breast
cancer provided that no more than 30% of marrow-bearing bone was irradiated.

- No signs and symptoms of CHF.

- Adequate hepatic and renal function values.

- Adequate hematologic function values.

Key Exclusion Criteria:

- Pregnant or lactating females.

- Previous chemotherapy for metastatic or locally recurrent breast cancer.

- Previous radiotherapy for the treatment of metastatic disease (unless given for the
relief of metastatic bone pain)

- Evidence of spinal cord compression or current evidence of central nervous system
(CNS) metastases.

- Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days
prior to randomization, or anticipation of the need for major surgery during the
course of the study treatment.

- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of

- Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).
Clinically significant (i.e. active) cardiovascular disease, requiring medication
during the study and might interfere with regularity of the study treatment, or not
controlled by medication.

- Non-healing wound, active peptic ulcer or bone fracture.

- History of abdominal fistula, or any grade 4 nongastrointestinal fistula,
gastrointestinal perforation or intrabdominal abscess within 6 months of

- Active infection requiring i.v. antibiotics at randomization.

- Clinically significant malabsorption syndrome or inability to take oral medication.

- Known hypersensitivity to any of the study drugs or excipients.

- Concurrent treatment with any drug interfering with study medication. Concurrent
participation in another clinical trial. Prior participation is allowed when the last
study medication was applied more than 4 weeks prior to randomization.

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 (PFS)

Outcome Time Frame:

end of trial

Safety Issue:


Principal Investigator

Susanna Hegewisch-Becker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Onkologische Schwerpunktpraxis Eppendorf


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

February 2009

Completion Date:

December 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms