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Enzalutamide · 1 trial · 1 indication
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and \>= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better.
| Arm | Type | Description |
|---|---|---|
| Fulvestrant Without Enzalutamide | PLACEBO_COMPARATOR | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| Fulvestrant With Enzalutamide | EXPERIMENTAL | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. |
| Name | Type | Description |
|---|---|---|
| Enzalutamide | DRUG | 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. |
| Fulvestrant | DRUG | 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
Inclusion Criteria: * ER+ Her2- breast cancer * Stage at least T2 or greater * Planned to get local surgery * Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression. * At least 18 years of age * Not on anticoagulants * PS 0-2 * Able to swallow study dr...
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Enzalutamide is being studied for the treatment of breast cancer, specifically in patients with ER+/HER2- breast cancer. It is currently in Phase 2 clinical development as a preoperative therapy, given with or without fulvestrant. The drug is being evaluated in a clinical trial enrolling female patients aged 18 years and older.
Enzalutamide is a small molecule that targets the androgen receptor. It works by blocking the androgen receptor signaling pathway, which is relevant in certain types of breast cancer. This mechanism is being investigated in the context of ER+/HER2- breast cancer, where androgen receptor activity may play a role in tumor growth.
Enzalutamide is being developed by United Therapeutics Corporation, a company traded under the ticker UTHR. The company is conducting a Phase 2 clinical trial to evaluate the drug as a preoperative treatment for ER+/HER2- breast cancer. The trial is active but not recruiting participants.
Enzalutamide is in Phase 2 clinical development for breast cancer. It is being studied as a preoperative therapy in combination with fulvestrant or as a single agent. The drug is investigational and has not been approved for this indication. The ongoing trial is active but not recruiting, with a planned enrollment of 61 participants.
Enzalutamide is being evaluated in a Phase 2 clinical trial with the identifier NCT02955394. The trial is titled 'Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer' and is being conducted in the United States. The study is active but not recruiting, with an enrollment of 61 female patients.
Enzalutamide is the generic name for the drug also known as Xtandi. In the context of breast cancer, it is being studied under the name Enzalutamide. The drug is a small molecule androgen receptor inhibitor. It is currently in Phase 2 trials for breast cancer, developed by United Therapeutics Corporation.