Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: 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.

Summary: 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.


Eligibility: 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.

Relevance to patient case: not relevant