At a glance
ClinicalIndex Comparison Record- ✓Female, age ≥18 years old
- ✓Histologically proven invasive breast carcinoma (core or incisional biopsy) scheduled for surgery as primary treatment
- ✓Known ER, PgR, and HER2 status
- ✓Tumor confined to breast or breast and ipsilateral axilla; T1 (≥1.0 cm), T2, or T3; N0 or N1 only; M0
- ✕T0, Tis, T1 <1.0 cm, T4; or N2-3; or M1 breast cancer
- ✕Bilateral invasive breast cancer
- ✕Prior excisional biopsy of the primary tumor
- ✕Need for breast surgery or NAST before completing ≥14 days of darolutamide, or refusal to undergo biopsy if NAST planned
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)
In Brief
A Early Phase 1 clinical trial evaluating darolutamide for Breast Cancer Female. Completed, enrolled 36 participants across 14 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
Study Details
Timeline
Interventions
Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.