Status:
TERMINATED
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recu...
Detailed Description
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regar...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
- Postmenopausal
- ECOG \[Eastern Cooperative Oncology Group\] \</=1
- Evaluable(e.g bone only disease allowed) and Measurable disease \[RECIST (Response Evaluation Criterion in Solid Tumors)\]
Exclusion
- HER2 \[Human Epidermal Growth factor Receptor 2\] positive disease not previously treated with herceptin
- Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
- Radiation therapy within 2 weeks of first study treatment
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00417885
Start Date
June 1 2007
End Date
July 1 2009
Last Update
September 21 2010
Active Locations (3)
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1
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
2
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
3
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1L5