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

NCT ID: NCT01025349

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Metastatic Breast Cancer

Keywords

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bevacizumab metastatic breast cancer docetaxel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metastatic breast cancer

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.

Group Type EXPERIMENTAL

Bevacizumab, docetaxel, cisplatin

Intervention Type DRUG

Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks.

docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks.

cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.

Interventions

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Bevacizumab, docetaxel, cisplatin

Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks.

docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks.

cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.

Intervention Type DRUG

Other Intervention Names

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bevacizumab: avastin docetaxel: taxotere

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Cheng-Jeng Tai, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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Miller KD, Sweeney CJ, Sledge GW Jr. Redefining the target: chemotherapeutics as antiangiogenics. J Clin Oncol. 2001 Feb 15;19(4):1195-206. doi: 10.1200/JCO.2001.19.4.1195.

Reference Type BACKGROUND
PMID: 11181686 (View on PubMed)

Moy B, Goss PE. Lapatinib: current status and future directions in breast cancer. Oncologist. 2006 Nov-Dec;11(10):1047-57. doi: 10.1634/theoncologist.11-10-1047.

Reference Type BACKGROUND
PMID: 17110623 (View on PubMed)

Chu E. Bevacizumab targeted therapy: validation of angiogenesis as a key target for advanced colorectal cancer. Clin Colorectal Cancer. 2004 May;4(1):16. doi: 10.3816/ccc.2004.n.006. No abstract available.

Reference Type BACKGROUND
PMID: 15207014 (View on PubMed)

Eniu A. Integrating biological agents into systemic therapy of breast cancer: trastuzumab, lapatinib, bevacizumab. J BUON. 2007 Sep;12 Suppl 1:S119-26.

Reference Type BACKGROUND
PMID: 17935269 (View on PubMed)

Caprioni F, Fornarini G. Bevacizumab in the treatment of metastatic colorectal cancer. Future Oncol. 2007 Apr;3(2):141-8. doi: 10.2217/14796694.3.2.141.

Reference Type BACKGROUND
PMID: 17381413 (View on PubMed)

Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. doi: 10.1200/JCO.2005.01.5388. Epub 2005 Dec 19.

Reference Type BACKGROUND
PMID: 16365183 (View on PubMed)

Link JS, Waisman JR, Nguyen B, Jacobs CI. Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer. Clin Breast Cancer. 2007 Oct;7(10):779-83. doi: 10.3816/CBC.2007.n.039.

Reference Type BACKGROUND
PMID: 18021479 (View on PubMed)

Other Identifiers

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TMUH-01-09-09

Identifier Type: -

Identifier Source: org_study_id