At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal women: age ≥60 with amenorrhea >12 months, OR age <60 with amenorrhea >12 months and FSH >35 mIU/mL, OR prior bilateral oophorectomy
- ✓Histologically confirmed metastatic or locally advanced, unresectable breast cancer
- ✓ER+ (≥10% cells positive) and HER2- breast cancer (by IHC 0-1+, or 2+ with negative ISH, or ISH non-amplified)
- ✓Measurable disease: ≥2.0 cm on chest X-ray or ≥1.0 cm on CT/MRI (not by physical exam alone)
- ✕Chemotherapy within 21 days of registration
- ✕Immunotherapy, biologic therapy, or monoclonal antibodies within 21 days of registration
- ✕Hormonal therapy or radiation therapy within 14 days of registration
- ✕Systemic infection requiring IV antibiotics within 14 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial to Evaluate Alisertib Alone or Combined With Fulvestrant for Women With Advanced, Endocrine-Resistant Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Alisertib, Fulvestrant, and 1 other intervention for Estrogen Receptor Status and 8 related conditions. Completed, enrolled 96 participants across 8 sites.
Detailed Summary
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.
Study Details
Timeline
Interventions
Given PO
Given IM
Correlative studies