Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Saint Luke's Health System
Study ID
NCT05025735
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Hyperglycemia is an expected effect of PI3K inhibitors given the pivotal role of PI3K in mediating the response to insulin in multiple tissues. Blocking insulin signaling by p110α inhibitors leads to glycogen breakdown in the liver along with decreased glucose uptake in peripheral tissues. The resulting hyperglycemia causes a compensatory response of increase insulin secretion by the pancreas. If concurrent treatment with dapagliflozin can abrogate the alpelisib induced hyperglycemia and subsequent rebound hyperinsulinemia it may significantly improve the therapeutic efficacy of alpelisib.

Study Details

This will be a single arm, open label pilot to test the combination of dapagliflozin, a commercially available SGLT-2 inhibitor, in combination with alpelisib + fulvestrant in patients with HR+/HER2- mBC. The objective of this study is to determine if the addition of dapagliflozin to the combination of alpelisib and fulvestrant leads to significant reduction in all-grade hyperglycemia.

Key Dates

Start date
Aug 25, 2021
Status verified
Oct 2021
Primary completion
Dec 31, 2022
Completion
Jul 31, 2023

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2 study of Fulvestrant, alpelisib and dapagliflozin
    A cycle length is defined as 28 days. Fulvestrant 500 mg intramuscular, Cycle 1, Day 1 and Day 15; Cycle 2 and beyond 500 mg Intramuscular Day 1. Alpelisib 300 mg by mouth, daily, continuously beginning on Cycle 1, Day 1. Dapagliflozin 10 mg by mouth, daily, continuously beginning Cycle 1, Day 3.

Primary Outcome Measure

Incidence of all grade hyperglycemia as assessed by CTCAE v5.0 [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Luke's Cancer InstituteKansas CityMissouri64111
Kelley Aldrich, RN
[email protected]
816-932-2677
Timothy J Pluard, MD (PRINCIPAL_INVESTIGATOR)
Elizabeth Cathcart-Rake, MD (SUB_INVESTIGATOR)

Find similar trials in Kansas City, MO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Saint Luke's Cancer Institute· Kansas City, MO

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