Study on Preoperative Fulvestrant With or Without Enzalutamide for ER+/Her2- Breast Cancer
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT02955394
This clinical trial is testing whether adding the drug enzalutamide to fulvestrant can improve treatment outcomes for postmenopausal women with locally advanced ER+/Her2- breast cancer who are scheduled for surgery after about 4 months of treatment.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of combining two drugs, fulvestrant and enzalutamide, compared to using fulvestrant alone in treating postmenopausal women with locally advanced ER+/Her2- breast cancer. Participants will receive treatment for about 4 months before undergoing surgery. The study aims to determine if the combination therapy offers better results.
Description
In this study, postmenopausal women with locally advanced ER+/Her2- breast cancer will be randomly assigned to one of two groups. One group will receive the standard treatment with fulvestrant, while the other group will receive a combination of fulvestrant and enzalutamide. All participants will have a tissue biopsy before starting treatment and again after about 4 weeks. Treatment will continue for approximately 4 months, after which participants will undergo surgery to remove the cancer. The study will help determine if the combination of fulvestrant and enzalutamide is more effective than fulvestrant alone.
Eligibility Criteria
Inclusion Criteria
- Have ER+ Her2- breast cancer
- Cancer stage T2 or higher
- Scheduled for local surgery
- Postmenopausal, or if pre- or peri-menopausal, must have ovarian suppression
- At least 18 years old
- Not taking blood thinners
- Performance status score between 0 and 2
- Able to swallow the study drug and follow study requirements
- Adequate blood cell counts and liver function as determined by specific tests
- Willing to donate blood and tissue samples for research
- Provide written informed consent before participating
Exclusion Criteria
- Have or had cancer spread to the brain or spinal fluid
- History of seizures
- Previous treatment with certain anti-androgen drugs
- Use of systemic estrogens or androgens within 14 days before starting the study (vaginal estrogens are allowed if needed for comfort)
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado | 80045 | Aurora | Colorado |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| West Cancer Center | 38138 | Germantown | Tennessee |
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