Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR 1
Breast Cancer
Joseph Kash, MD

Naperville, Plainfield

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Sponsor: Novartis Pharmaceuticals Corp

https://clinicaltrials.gov/ct2/show/NCT02437318?term=solar-1&rank=1

  • MALES MEETING OTHER CRITERIA ARE ELIGIBLE
  • If female, patient is postmenopausal
  • Relapsed with documented evidence of progression on or following endocrine therapy
  • Recurrence or progression of disease during or after AI therapy (i.e.  letrozole, anastrozole, exemestane).
  • Confirmed diagnosis of estrogen-receptor positive (ER+) and HER2 negative breast cancer
  • Adequate bone marrow function
  • No prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
  • No inflammatory breast cancer at screening
  • No established diagnosis of diabetes mellitus type I or not controlled type II

5-6 years

Pending IRB Approval for Recruiting
Interventional
III
Kathy Seymour, BSN
630-646-6050
630-646-6110
630-646-6075