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Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

Elderly individuals make up a large part of the breast cancer population. Older women are
more likely than younger women to be diagnosed at a more advanced stage of breast cancer.
However, when treated with chemotherapy for metastatic disease they derive similar benefits
to their younger counterparts. Preference should be given to chemotherapeutic drugs with
safer profiles regimens, such as weekly taxane, according to the SIOG recommendations.
Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab
demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic breast adenocarcinoma

- No previous therapy (other than hormonal therapy) for metastatic disease is accepted

- Measurable disease as defined by the presence of at least one measurable lesion
(except bone metastases, ascites or pleural effusions)

- Performance status (WHO) 0-2

- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT
<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or
<5 times the upper normal limit in the presence of liver metastases)

- adequate renal function (serum creatinine <1.5 times the upper normal limit)

- bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

- No radiation of measurable disease (except brain metastases)

- No progressive brain metastases according to clinical or radiological criteria

- No brain metastases without prior radiation therapy

- Written informed consent

Exclusion Criteria:

- Active infection

- History of significant cardiac disease (unstable angina, congestive heart failure,
myocardial infarction within the previous 6 months, ventricular arrhythmias)

- History of stroke

- Anticoagulation therapy (except of low dose aspirin <325mg)

- Other invasive malignancy except non-melanoma skin cancer

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

Objective responses confirmed by CT or MRI every 3 months

Safety Issue:


Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete


Greece: National Organization of Medicines

Study ID:




Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Elderly
  • Chemotherapy
  • Anti-angiogenesis therapy
  • Breast Neoplasms