Clinical trial · Interventional
Study of AFP464 +/- Faslodex in ER + Breast Cancer
A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy
NCT01233947CI-TRIAL-00006024terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFP464 | Drug | — | UNRESOLVED |
| AFP464 + Faslodex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AFP464
- description
- 74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.
- interventionNames
- Drug: AFP464
- type
- EXPERIMENTAL
- label
- AFP464 + Faslodex
- description
- AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.
- interventionNames
- Drug: AFP464 + Faslodex
Primary outcomes (1)
- measure
- Clinical Benefit Response
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29\>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1. Exclusion Criteria: * HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
References
Publications (0)
Data not yet available
No reference posted for this study.