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Retrospective Analysis of Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

Phase 2
18 Years
65 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Retrospective Analysis of Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

Targeted chemotherapy has gradually become the mainstay of cancer treatment in present day.
Targeted medications such as trastuzumab, bevacizumab and lapatinib have recently been more
extensively adopted for many cancers, particularly breast cancer. Among these targeted
medications, bevacizumab is a monoclonal antibody acting on vascular endothelial growth
factor receptor and it works by preventing the formation of new blood vessels
(angiogenesis). Published articles indicated that monotherapy of bevacizumab on breast
cancer showed only a 9-17% response rate, while combining with paclitaxel, the treatment
outcome appeared to improve progression-free survival and the objective response rate. We
are curious about the additive effect of bevacizumab on conventional chemotherapy, the
toxicities induced when combined target therapy with conventional chemotherapy and the
duration of remission that these treatment could achieve. In this study, we utilized
bevacizumab, docetaxel plus cisplatin for metastatic breast cancer patients and furthermore,
we are evaluated the treatment response, toxicities and duration of remission as our main

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

- Normal left ventricular ejection fraction (LVEF).

- Age ≤ 65 years.

- At least one unidimensionally measurable lesion by imaging studies.

- AST/ALT 2.5 ULN (< 5 ULN if liver metastases).

- Serum bilirubin 3 ULN, Serum Creatinine 1.5 ULN.

- Urine dipstick of proteinuria <2+.

- Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood
pressure > 90 mm Hg).

- Prior exposure to bevacizumab.

- Planned radiotherapy for underlying disease (prior completed radiotherapy treatment
allowed), except bone metastasis.

- Evidence of bleeding diathesis or coagulopathy.

- Clinically significant (i.e. active) cardiovascular disease for example
cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable
angina, New York Heart Association (NYHA) grade II or greater congestive heart
failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six

- Evidence of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of bevacizumab with chemotherapy.

- Ongoing treatment with aspirin (> 325 mg/day) or other medications known to
predispose to gastrointestinal ulceration.

- Pregnancy (positive serum pregnancy test) and lactation. Any other serious or
uncontrolled illness which, in the opinion of the investigator, makes it undesirable
for the patient to enter the trial.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Cheng-Jeng Tai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

September 2009

Related Keywords:

  • Metastatic Breast Cancer
  • bevacizumab
  • metastatic breast cancer
  • docetaxel
  • Breast Neoplasms