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Dapagliflozin for Early-Stage Breast Cancer
Phase 1
Waitlist Available
Led By Maryam Lustberg, MD, MPH
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants should have adequate organ function to tolerate chemotherapy, as defined by: peripheral granulocyte count of > 1,500/mm3; platelet count > 100,000/mm3; hemoglobin >9 g/dL; total bilirubin < 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each < 1.5 x ULN; serum creatinine < 1.5 x ULN; INR/PT/PTT each < 1.5 x ULN; Able to swallow oral formulation of the study agent
Acceptable chemotherapy regimens include: Weekly paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide; Docetaxel plus cyclophosphamide; Docetaxel plus carboplatin; 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy
Awards & highlights
Study Summary
This trial looks at how a diabetes drug affects breast cancer patients with early stage, HER2-negative tumors during treatment.
Who is the study for?
This trial is for women with early-stage HER2-negative breast cancer, BMI ≥ 25 kg/m², and hyperinsulinemia (HOMA-IR ≥ 2.5). They must be willing to use two birth control methods or abstain from sex, have no history of severe allergies to dapagliflozin, not currently pregnant/breastfeeding, without diabetes mellitus or recent significant weight changes.Check my eligibility
What is being tested?
The study tests the effects of Dapagliflozin (10mg) on insulin resistance markers in patients undergoing neoadjuvant therapy for breast cancer. It involves taking Dapagliflozin alongside standard chemotherapy regimens and assessing metabolic changes.See study design
What are the potential side effects?
Dapagliflozin may cause urinary tract infections, dehydration symptoms like dizziness or faintness due to low blood pressure, potential increase in cholesterol levels, and a rare risk of diabetic ketoacidosis even if you don't have diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show I can safely receive chemotherapy.
Select...
I am on or eligible for specific chemotherapy combinations for my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Secondary outcome measures
Change in Adiponectin concentration
Change in Beta-hydroxybuterate concentration
Change in Fasting glucose concentration
+9 moreSide effects data
From 2017 Phase 3 trial • 151 Patients • NCT0258281433%
NASOPHARYNGITIS
9%
POLLAKIURIA
9%
GASTROENTERITIS
8%
BACK PAIN
7%
PHARYNGITIS
5%
HEADACHE
5%
KETOSIS
5%
INFLUENZA
5%
THIRST
5%
ECZEMA
3%
BRONCHITIS
3%
DIABETIC KETOACIDOSIS
1%
HEPATIC FUNCTION ABNORMAL
1%
ATRIAL FIBRILLATION
1%
OSTEOARTHRITIS
1%
ABORTION SPONTANEOUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin 5mg + Insulin
Dapagliflozin 10mg + Insulin
Trial Design
1Treatment groups
Experimental Treatment
Group I: DapagliflozinExperimental Treatment1 Intervention
All participants (with insulin resistance and Estrogen Receptor (ER)+HER2-negative or ER/Progesterone receptor (PR)/HER2-negative breast cancer) will receive current standard of care neoadjuvant chemotherapy as determined by the treating physician, plus dapagliflozin 10 mg orally taken daily throughout chemotherapy treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10mg
2016
Completed Phase 4
~1430
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,648 Total Patients Enrolled
2 Trials studying Hyperinsulinemia
228 Patients Enrolled for Hyperinsulinemia
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,882 Total Patients Enrolled
Maryam Lustberg, MD, MPHPrincipal InvestigatorYale University
2 Previous Clinical Trials
312 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a recent negative pregnancy test.I have not received any live vaccines in the last 30 days.I have been diagnosed with type I or II diabetes.I am willing to have a biopsy after 12 weeks of treatment.I have not had certain breast surgeries that make it hard to assess my cancer response.I will not donate blood during the study or for 3 months after my last chemotherapy dose.My kidney function is low, with an eGFR below 25.I have not been in a weight loss program or lost more than 5% of my weight in the last 3 months, and I haven't had gastrointestinal surgery.My blood tests show I can safely receive chemotherapy.I cannot receive certain chemotherapies due to health risks.I am a woman with early-stage, HER2-negative breast cancer and need chemotherapy before surgery.I can provide breast cancer tissue from a past biopsy or am willing to have a new biopsy for the study.You are overweight, with a BMI of 25 or higher.I haven't taken any diabetes medication that affects insulin resistance in the last month.I am on or eligible for specific chemotherapy combinations for my cancer.You have had a bad reaction to dapagliflozin in the past.I have had multiple urinary tract infections in the past year.Your body has too much insulin, which is measured by a test called HOMA-IR and is equal to or greater than 2.5.
Research Study Groups:
This trial has the following groups:- Group 1: Dapagliflozin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dapagliflozin been granted the sanction of the FDA?
"There is minimal clinical data supporting the safety and efficacy of Dapagliflozin—therefore, it was allocated a score of 1."
Answered by AI
Are individuals currently being recruited for this clinical experiment?
"Per the data available on clinicaltrials.gov, this trial is not recruiting new patients at present. It was posted on September 1st 2023 and last updated three weeks later; however 2712 other medical studies are currently enrolling candidates."
Answered by AI
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