At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic breast cancer with prior aromatase inhibitor failure (progression on treatment, recurrence during/within 12 months of adjuvant AI, or AI intolerance)
- ✓Estrogen or progesterone receptor expression required
- ✓ECOG performance status 0-2
- ✓Age >18 years
- ✕Prior tamoxifen for metastatic disease (adjuvant tamoxifen allowed if completed >12 months prior)
- ✕Uncontrolled CNS metastases or history of seizures
- ✕Known hypersensitivity to tamoxifen
- ✕History of blood clots
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) in Combination With Tamoxifen for Patients With Advanced Breast Cancer Who Have Failed Prior Anti-hormonal Therapy.
In Brief
A Phase 2 clinical trial evaluating suberoylanilide hydroxamic acid (SAHA, Vorinostat) and tamoxifen citrate (Tamoxifen) for Breast Cancer. Completed, enrolled 43 participants across 8 sites.
Detailed Summary
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.
Study Details
Timeline
Interventions
Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).