Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University
About this trial
The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.
Eligibility criteria
Qualifiers
Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide
Docetaxel plus cyclophosphamide
Docetaxel plus carboplatin plus or minus pembrolizumab
Paclitaxel plus carboplatin concurrent with every 3 week pembrolizumab followed by dose dense doxorubicin plus cyclophosphamide concurrent with every 3 week pembrolizumab (KEYNOTE-522 regimen; only for participants with triple negative breast cancer)
Disqualifiers
Participants who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy and therefore cannot be assessed accurately for pathologic response, are not eligible.
Participants currently pregnant or breastfeeding.
Participants for whom any of the planned chemotherapies are contraindicated.
Participants with currently diagnosed type I or II diabetes mellitus.
Trial design
Treatments tested in this trial
- Dapagliflozin 10mg
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1Yale Cancer Center Smilow Cancer Hospital06520, New HavenConnecticut, United States
Sponsors and collaborators
Yale University
Lead sponsor
Source ClinicalTrials.gov