Dapagliflozin 10Mg Tab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Saint Luke's Cancer Institute, Kansas City, MO
Breast Cancer+2 More
Dapagliflozin 10Mg Tab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called dapagliflozin can be used to treat breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • HER2-negative Breast Cancer
  • Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Dapagliflozin 10Mg Tab will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Through study completion, an average of 1 year..

Year 1
Incidence of Grade 3/4 hyperglycemia as assessed by CTCAE v5.0
Incidence of all grade hyperglycemia as assessed by CTCAE v5.0
Overall response rate (ORR) as assed by RECIST 1.1 in patients with measurable disease
Progression free survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

1 Treatment Group

Phase 2 study of Fulvestrant, alpelisib and dapagliflozin
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. Dapagliflozin 10Mg Tab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Phase 2 study of Fulvestrant, alpelisib and dapagliflozin
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year. for reporting.

Closest Location

Saint Luke's Cancer Institute - Kansas City, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Breast Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
ER and/or PR positive by local laboratory evaluation
HER2 negative as defined by: either IHC status of 0, 1+ ; IHC of 2+ with FISH negative by ASCO/CAP guidelines.
If female, post-menopausal status as defined by
Prior bilateral oophorectomy
Age > 60
Age <60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene; or ovarian suppression and Follicle-stimulating Hormone (FSH) and estradiol in the postmenopausal range per local normal range.
Current use of LHRH agonist for ovarian suppression and estradiol and FSH documented in the post-menopausal range.
PIK3CA activating mutation identified by a either in a CLIA certified tumor genomic assay or ctDNA assay.
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
relapsed with documented evidence of progression more than 12 months following/completion of (neo)adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease

Patient Q&A Section

What is the latest research for breast cancer?

"The incidence of breast cancer has increased since 1976; however, mortality rates have decreased by 62% during the same period of time. Although aggressive screening methods are being used, the rate of detection is still low; therefore, prevention through lifestyle changes or hormonal replacement therapy can reduce mortality related to breast cancer. More research is needed to decrease the mortality rate." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is one of the common cancers in women. The incidence of breast cancer has increased over past 30 years. Significant contribution from environmental factors like diet intake, physical activity, smoking etc. is also being noticed. The mortality rates however remain comparatively low. This must be attributed to the aggressive nature of the illness." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The evidence suggests that there are multiple risk factors. The tryptophan metabolism hypothesis is based mainly on animal studies; however, a recent meta-analysis suggests that there may be no association between the 5HTTLPR polymorphism and breast cancer risk. There is evidence supporting an association between obesity and breast cancer risk, but this requires confirmation." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"Data from a recent study showed that the lifetime risk of getting breast cancer is highest at age 50, and then decreases steadily until age 90. However, because there were relatively few people who got breast cancer before age 40, we weren't able to estimate the average age that breast cancer happens at this young age.\n" - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"The current standard for staging and classifying breast cancers is based on tumor size and grade. However, because large tumors tend to have advanced stages (more distant metastases), it is unclear whether all cases of breast cancer should be staged according to tumor size or other factors such as tumor grade or tumor placement. In addition, because invasive breast cancers tend to have higher prevalence of microvascular invasion, it is not clear whether they should be classified as high grade or low grade. Although the current TNM staging system is a useful guide for determining prognosis and predicting clinical outcomes, further research is needed to understand how different imaging techniques, including MRI and ultrasound, may help to evaluate local tumor extension and metastatic involvement." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"Advanced stage breast cancer is associated with decreased survival compared to localized disease. Even in patients who had undergone mastectomy, advanced stage disease was associated with decreased survival. If metastatic disease occurs, even with adjuvant chemotherapy, the prognosis is poor, as well." - Anonymous Online Contributor

Unverified Answer

Does dapagliflozin 10mg tab improve quality of life for those with breast cancer?

"Dapagliflozin treatment over 12 weeks resulted in significant improvements in HRQOL as measured by all three QoL domains. Results from a recent paper were consistent with previous studies on diabetes patients not receiving SGLT2 inhibitors." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dapagliflozin 10mg tab?

"Dapagliflozin was well tolerated in patients with type 2 diabetes mellitus receiving antidiabetic therapy. The two most common adverse events were hypersensitivity reactions and hypoglycemia." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in dapagliflozin 10mg tab for therapeutic use?

"Dapagliflozin has demonstrated superiority over other glucose-lowering agents and has been shown to increase insulin sensitivity in patients with type 2 diabetes mellitus (T2DM). The 10 mg dosage provides stability of therapeutic efficacy while improving tolerability compared to the 5 mg dosage used in clinical trials. Recent findings support further investigations into the potential use of dapagliflozin as a treatment option for T2DM." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"Results from a recent clinical trial from this study show that environmental exposures play an important role in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) development. Furthermore, when compared to non-breast cancers, breast cancer was found to be more prevalent in women having a family history of cancer." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"The U.S. Preventive Services Task Force estimates that there are approximately 1.5 million new cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) each year in the US. This estimate is similar to one made by the American Cancer Society. However, this actual number is likely overestimated due to underreporting by health professionals. Because of the large number of newly diagnosed cancers annually, the estimated prevalence of breast cancer is relatively low, suggesting that only a small fraction of prevalent breast cancers are detected or diagnosed each year. These statistics may provide valuable information for public health initiatives aimed at improving detection rates." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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