NCT04899349: Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+, PR+
Other Mutations: PI3K
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 2
Drug Category: Endocrine (Hormone Therapy, Serine-Threonine Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patients must have a has a PIK3CA mutation(s) present in tumor; Patients must have had prior endocrine-based treatment (i.e. letrozole, anastrozole, exemestane, fulvestrant or oral SERD)
Exclusions: Patients with inflammatory breast cancer; Patients who are newly diagnosed & have never had endocrine-based treatment; Patients who had more than 1 line of prior treatment in the metastatic setting; Patients who received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy, any PI3K inhibitor (e.g. Piqray/alpelisib), mTOR inhibitor (e.g. Afinitor/everolimus), or Akt inhibitor (e.g. ONC201)

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