SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment [Protocol: CBYL719C2301]

Trial ID:
IRB-15-6718
Melissa Torrey
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.

Inclusion Criteria:

  • If female, patient is postmenopausal
  • Patient has identified PIK3CA status
  • Patients may be:
    • relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
    • relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
    • newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy
  • Patient has recurrence or progression of disease during or after AI therapy (i.e.

letrozole, anastrozole, exemestane).

  • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
  • Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
  • Patient has adequate bone marrow function

Exclusion Criteria:

  • Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
  • Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
  • Patient with inflammatory breast cancer at screening
  • Patients with Child pugh score B or C
  • Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
  • Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases
  • Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
  • Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
  • Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

Other protocol-defined inclusion/esclusion criteria may apply.

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