Drug Combination Treatment Study for Patients with Advanced or Metastatic Breast Cancer
The main purpose of this study is to determine the efficacy and safety of taking a combination of fulvestrant plus the experimental drug MLN0128 compared to taking fulvestrant only. MLN0128 is being tested to treat postmenopausal women with advanced or metastatic breast cancer that has progressed during or after aromatase inhibitor (AI) therapy. This is a multicenter study that will be conducted worldwide.
In order to participate you must meet the following criteria:
- Are a postmenopausal female.
- Have a diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence.
- Have progressive disease (PD) during prior aromatase inhibitor (AI) therapy.
- Have the ability to swallow oral medications and have suitable vein access for the study-required blood sampling.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior therapy with mechanistic target of rapamycin (mTOR), phosphoinositide-3-kinase (PI3K), or dual PI3K-mTOR inhibitors, serine/threonine-specific protein kinase (AKT) inhibitors, or fulvestrant.
- Have had prior treatment with >1 line of chemotherapy for metastatic breast cancer or for recurrence that was not amenable to resection or radiation therapy with curative intent.
- Have experienced PD on >2 endocrine therapies for metastatic breast cancer or recurrence that was not amenable to resection or radiation therapy with curative intent.
- Have other clinically significant comorbidities.
This is a partial list of inclusion and exclusion criteria.