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EPIK-B4: A Phase II, multicenter, randomized, open-label, active-controlled study to assess the safety and efficacy of dapagliflozin + metformin XR versus metformin XR during treatment with alpelisib (BYL719) in combination with fulvestrant in participants with HR+, HER2-, advanced Breast Cancer with a PIK3CA mutation following progression on/after endocrine-based therapy
Overall Recruitment Status: Enrollment not started
 
Official Title
EPIK-B4: A Phase II, multicenter, randomized, open-label, active-controlled study to assess the safety and efficacy of dapagliflozin + metformin XR versus metformin XR during treatment with alpelisib (BYL719) in combination with fulvestrant in participants with HR+, HER2-, advanced Breast Cancer with a PIK3CA mutation following progression on/after endocrine-based therapy
 
Region Sponsors
Hawaii
Norvartis
 
Acronym KP IRB No.
1803565
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
 
Purpose
The purpose of the study is to learn how to treat and/or prevent high blood sugar levels which are often seen in patients with advanced breast cancer when treated with alpelisib plus fulvestrant.
 
Detailed Description
Study CBYL719C2202 (EPIK-B4) will assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR, during treatment with alpelisib plus fulvestrant in participants with Hormone Receptor (HR) positive, Human Epidermal growth factor Receptor-2 (HER2) negative advanced breast cancer with a Phosphoinositide-3-Kinase Catalytic subunit Alpha (PIK3CA) mutation following progression on or after endocrine-based therapy. The purpose of this study is to determine if the combination of dapagliflozin plus metformin XR, when given prophylactically to participants considered at ‘high-risk’ for the development of hyperglycemia, leads to a greater reduction in severe hyperglycemia events compared with the prophylactic use of metformin XR alone. In SOLAR-1, 71% of all alpelisib-treated patients and 85% of alpelisib-treated patients who developed Grade 3 or 4 hyperglycemia were considered "high-risk" for the development of hyperglycemia. Patients were considered to be "high-risk" if they had either diabetes, pre-diabetes, obesity (Body Mass Index (BMI) = 30) or age = 75 years. This strategy is intended to optimize prophylactic management of hyperglycemia for participants with underlying risk factors for the development of severe hyperglycemia.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • ? Participant has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer by local laboratory ? Participant has a PIK3CA mutation(s) present in tumor prior to enrollment ? Participant has prior treatment with an endocrine-based treatment (i.e. letrozole, anastrozole, exemestane, fulvestrant or oral SERD) and may be: ?relapsed with documented evidence of progression while on (neo) adjuvant endocrine based therapy or within 12 months from completion of (neo)adjuvant endocrine-based therapy with no treatment for metastatic disease ?relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine-based therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine-based 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-based therapy
 
Exclusion Criteria
  • ? Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease ? Participant had more than 1 line of prior treatment in the metastatic setting ? Participant has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), any PI3K, Mammalian Target of Rapamycin (mTOR) or Protein Kinase B (Akt) inhibitor ? Participant has inflammatory breast cancer at screening ? Participant with an established diagnosis of diabetes mellitus type I or participants with type II diabetes mellitus requiring antihyperglycemic therapy

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer F Carney, MD
Contact Information:
- Shelley A Clark, RN
-Moanalua Medical Center and Clinic


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