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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2013 |
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Main ID: |
NCT00428922 |
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Date of registration:
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29/01/2007 |
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Primary sponsor: |
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Public title:
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Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
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Scientific title:
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Phase II Trial of Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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39 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00428922 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles L Shapiro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed breast cancer with evidence of metastatic disease
- HER2 3+ or FISH +
- Age = 18 years
- No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
- No prior chemotherapy in the metastatic setting.
Exclusion Criteria:
- CNS metastases
- Prior radiation therapy within the last 4 weeks
- Pregnant (positive pregnancy test) or lactating women
- Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic
injury within 28 days prior to starting study or anticipation of need for major
surgical procedure during the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to start of study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Bevacizumab
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Drug: Docetaxel
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Drug: Trastuzumab
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Primary Outcome(s)
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The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.
[Time Frame: up to 12 months]
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Secondary Outcome(s)
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Changes in CTCs and CECs as predictors of PFS and clinical benefit
[Time Frame: up to 12 months]
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Overall clinical benefit rate (CR+PR+SD)
[Time Frame: up to 12 months]
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Secondary ID(s)
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NCI-2011-03219
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OSU-06027
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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