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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Bevacizumab, docetaxel, cisplatin

• Registration Number: NCT01025349
• Lead Sponsor: Taipei Medical University Hospital

Brief Summary

Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer. It works by preventing the formation of new blood vessels (angiogenesis). The drug has been shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed positive findings in other solid tumors that had metastasized. In this study, the investigators are investigating the response of adding bevacizumab to conventional chemotherapy for metastatic breast cancer patients.

Detailed Description

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 goals.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-02
• Last Update Submitted: 2009-12-02
• Study First Posted: 2009-12-03
• Last Update Posted: 2009-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 months.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
metastatic breast cancer	Bevacizumab, docetaxel, cisplatin	Patients with histological or cytological proven metastatic breast cancer were recruited. The previous hormonal therapy for metastatic breast cancer or cytotoxic therapy was allowed. The Her2/Neu over-expressive status should be negative. Patients with brain metastasis are excluded.

Primary Outcome Measures

Name	Time	Method
Response Rate	every 3 months

Secondary Outcome Measures

Name	Time	Method
Time to Progression(TTP), Progression free survival, overall survival, safety, Quality of Life	every 3 months

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan