Trial Outcomes & Findings for Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (NCT NCT04899349)
NCT ID: NCT04899349
Last Updated: 2024-10-09
Results Overview
Number of participants with severe hyperglycemia over the first eight weeks of alpelisib plus fulvestrant treatment. Severe hyperglycemia (Grade ≥ 3) is defined as any glucose laboratory values \> 250 milligram (mg)/ deciliter (dL) (\> 13.9 millimole (mmol)/ liter (L))
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
From Cycle 1 Day 8 to Cycle 3 Day 8 (first eight weeks of treatment with alpelisib). Cycle = 28 days.
Results posted on
2024-10-09
Participant Flow
2 sites in 2 countries enrolled participants
Screening assessments were conducted up to 21 days prior to the randomization. The trial was early terminated and no patients were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
Participant milestones
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
2
|
0
|
Baseline Characteristics
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
Baseline characteristics by cohort
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 Years
STANDARD_DEVIATION 4.24 • n=5 Participants
|
—
|
70 Years
STANDARD_DEVIATION 4.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 Day 8 to Cycle 3 Day 8 (first eight weeks of treatment with alpelisib). Cycle = 28 days.Population: All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
Number of participants with severe hyperglycemia over the first eight weeks of alpelisib plus fulvestrant treatment. Severe hyperglycemia (Grade ≥ 3) is defined as any glucose laboratory values \> 250 milligram (mg)/ deciliter (dL) (\> 13.9 millimole (mmol)/ liter (L))
Outcome measures
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Number of Participants With Hyperglycemia Grade ≥ 3 Over the First Eight Weeks of Alpelisib Plus Fulvestrant Treatment
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of the first documented progression or death due to any cause, whichever comes first, assessed up to a maximum duration of 7.4 monthsPopulation: All participants to whom study treatment was assigned by randomization. The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local investigator assessment according to RECIST 1.1. If a subject did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was using the Kaplan-Meier method, and the Kaplan-Meier median and 95% confidence intervals of the medians was presented.
Outcome measures
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Progression-free Survival (PFS) Based on Local Investigator Assessment
|
NA Months
NA. Not estimable as none of the participants had an event
|
—
|
SECONDARY outcome
Timeframe: Up to 7.4 monthsPopulation: All participants to whom study treatment was assigned by randomization. The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
ORR with confirmed response was defined as the percentage of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on local investigator's assessment according to RECIST 1.1. CR: Disappearance of all non-nodal target lesions and all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions and all lymph nodes assigned as non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Overall Response Rate (ORR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1.
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 7.4 monthsPopulation: All participants to whom study treatment was assigned by randomization. The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
Clinical benefit rate with confirmed response was defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR or stable disease (SD) or Non-CR/Non-progressive disease (PD) lasting more than 24 weeks based on local investigator assessment as per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions and all lymph nodes assigned as non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Clinical Benefit Rate (CBR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 monthsPopulation: All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
Number of participants with dose interruptions and dose reductions
Outcome measures
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 Participants
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Number of Participants With Dose Modifications
Dose interruptions
|
1 Participants
|
0 Participants
|
|
Number of Participants With Dose Modifications
Dose reductions
|
2 Participants
|
0 Participants
|
Adverse Events
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alpelisib + Fulvestrant + Metformin XR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
n=2 participants at risk
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
|
Alpelisib + Fulvestrant + Metformin XR
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
General disorders
Fatigue
|
100.0%
2/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
General disorders
Peripheral swelling
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Immune system disorders
Hypersensitivity
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Investigations
Blood cholesterol increased
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Investigations
Blood creatinine increased
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Investigations
Weight decreased
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
2/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Nervous system disorders
Taste disorder
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Vascular disorders
Hot flush
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
—
0/0 • From first dose of study medication up to 30 days after last dose of study medication, assessed up to 7.4 months
All participants who received at least one dose of study treatment (i.e. at least one dose of any component of alpelisib, fulvestrant, dapagliflozin + metformin XR, metformin XR). The trial was early terminated and no participants were randomized to the Alpelisib + Fulvestrant + Metformin XR arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER