Clinical trial · Interventional
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER
NCT01597193CI-TRIAL-00038519completedPhase 1Results postedClinicalTrials.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)
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| enzalutamide | Drug | Enzalutamide | ALIAS |
| exemestane | Drug | Exemestane | ALIAS |
| fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- enzalutamide (80-mg with increase to 160 mg)
- description
- enzalutamide be provided as two or four 40-mg capsules by mouth daily
- interventionNames
- Drug: enzalutamide
- type
- EXPERIMENTAL
- label
- enzalutamide and anastrozole
- description
- enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
- interventionNames
- Drug: anastrozole
- Drug: enzalutamide
- type
- EXPERIMENTAL
- label
- enzalutamide and exemestane 25 mg
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer with accompanying pathology report; * Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides * Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only); * Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1; * Estimated life expectancy of at least 3 months Exclusion Criteria: * Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment; * Pregnant or lactating; * Known or suspected brain metastasis or leptomeningeal disease; * History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas; * For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
References
Publications (0)
Data not yet available
No reference posted for this study.