Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
NCT00471276
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- Histologically or cytologically proven diagnosis of breast cancer
- Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
- Patients with at least one measurable lesion as per RECIST
- Inflammatory breast cancer
- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months
ago)
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer | |||
Official Title ICMJE | A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer | |||
Brief Summary | Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE | Drug: sunitinib
sunitinib (Sutent), 37.5 mg, daily dosing Other Name: Sutent, sunitinib | |||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: sunitinib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 83 | |||
Original Enrollment ICMJE | 88 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00471276 | |||
Other Study ID Numbers ICMJE | A6181068 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |