Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.


Eligibility: Inclusion Criteria:
  -  Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
  -  Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
  -  Recurrence or progression during or after aromatase inhibitor
  -  Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  -  Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas® PIK3CA mutation result by central testing is required
  -  Adequate hematologic and end-organ function within 28 days prior to treatment initiation
  Exclusion Criteria:
  -  HER2-positive disease by local laboratory testing (immunohistochemistry [IHC] 3+ staining or in situ hybridization positive)
  -  Prior treatment with fulvestrant
  -  Prior treatment with a PI3K inhibitor, mTOR inhibitor (e.g. everolimus), or AKT inhibitor
  -  Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
  -  Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
  -  All acute treatment-related toxicity must have resolved to Grade </= 1 or be deemed stable by the Investigator
  -  Prior treatment with > 1 cytotoxic chemotherapy regimen for metastatic breast cancer
  -  Concurrent hormone replacement therapy
  -  Known untreated or active central nervous system (CNS) metastases
  -  Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
  -  History of inflammatory bowel disease or active bowel inflammation
  -  Clinically significant cardiac or pulmonary dysfunction
  -  Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B or C virus

Relevance to patient case: not relevant