A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Neoplasm
Both
Breast Neoplasm
Trial Information
A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
Inclusion Criteria:
- ER+ or TN Breast Cancer
- Progression on an aromatase inhibitor if ER+
- Prior treatment with taxane if TN
- 18 years or older
- Adequate organ function
- Measurable lesion
Exclusion Criteria:
- symptomatic pulmonary disease
- brain metastases
- pregnant females
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical Benefit Response
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
TG-AFP-002
NCT ID:
NCT01015521
Start Date:
April 2010
Completion Date:
Related Keywords:
- Breast Neoplasm
- breast cancer
- Breast Neoplasms
- Neoplasms
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