Trial Outcomes & Findings for Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk (NCT NCT02028221)
NCT ID: NCT02028221
Last Updated: 2023-06-27
Results Overview
change of dense breast volume at 6 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
baseline, 6 months
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Placebo
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
|
Overall Study
COMPLETED
|
62
|
56
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Baseline characteristics by cohort
| Measure |
Placebo
n=75 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
151 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis was performed on participants who provided baseline and 6 month breast density measures
change of dense breast volume at 6 months
Outcome measures
| Measure |
Placebo
n=41 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=38 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change in Breast Density at 6 Months
|
-5.45 cm^3
Standard Deviation 48.91
|
-13.71 cm^3
Standard Deviation 56.69
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Analysis was performed on participants who provided baseline and 12-month breast density measures
Change in dense breast volume at 12 months
Outcome measures
| Measure |
Placebo
n=43 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=39 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change in Breast Density at 12 Months
|
-12.11 cm^3
Standard Deviation 68.11
|
-14.75 cm^3
Standard Deviation 47.84
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: The number of participants analyzed refers to the number of participants with baseline data
Outcome measures
| Measure |
Placebo
n=74 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change From Baseline in Serum Insulin Levels at 6 and 12 Months
Baseline
|
14.6 uIU/ml
Standard Deviation 8.2
|
13.5 uIU/ml
Standard Deviation 8.7
|
|
Change From Baseline in Serum Insulin Levels at 6 and 12 Months
6 months
|
14.0 uIU/ml
Standard Deviation 8.0
|
11.9 uIU/ml
Standard Deviation 8.0
|
|
Change From Baseline in Serum Insulin Levels at 6 and 12 Months
12 months
|
13.1 uIU/ml
Standard Deviation 7.5
|
11.7 uIU/ml
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: The number of participants analyzed refers to the number of participants with baseline data
Outcome measures
| Measure |
Placebo
n=74 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change From Baseline in Serum IGF-1 to IGFBP-3 Ratio at 6 and 12 Months
12 months
|
0.171 data presented as ratio; no unit
Standard Deviation 0.063
|
0.165 data presented as ratio; no unit
Standard Deviation 0.060
|
|
Change From Baseline in Serum IGF-1 to IGFBP-3 Ratio at 6 and 12 Months
Baseline
|
0.178 data presented as ratio; no unit
Standard Deviation 0.063
|
0.170 data presented as ratio; no unit
Standard Deviation 0.061
|
|
Change From Baseline in Serum IGF-1 to IGFBP-3 Ratio at 6 and 12 Months
6 months
|
0.178 data presented as ratio; no unit
Standard Deviation 0.065
|
0.169 data presented as ratio; no unit
Standard Deviation 0.061
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: The number of participants analyzed refers to the number of participants with baseline data
Outcome measures
| Measure |
Placebo
n=74 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change From Baseline in Serum Leptin to Adiponectin Ratio at 6 and 12 Months
Baseline
|
0.023 data presented as ratio; no unit
Standard Deviation 0.025
|
0.028 data presented as ratio; no unit
Standard Deviation 0.051
|
|
Change From Baseline in Serum Leptin to Adiponectin Ratio at 6 and 12 Months
6 months
|
0.022 data presented as ratio; no unit
Standard Deviation 0.024
|
0.025 data presented as ratio; no unit
Standard Deviation 0.047
|
|
Change From Baseline in Serum Leptin to Adiponectin Ratio at 6 and 12 Months
12 months
|
0.021 data presented as ratio; no unit
Standard Deviation 0.024
|
0.026 data presented as ratio; no unit
Standard Deviation 0.052
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: The number of participants analyzed refers to the number of participants with baseline data
Outcome measures
| Measure |
Placebo
n=75 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change From Baseline in Body Weight at 6 and 12 Months
Baseline
|
102.3 kg
Standard Deviation 16.3
|
101.5 kg
Standard Deviation 18.9
|
|
Change From Baseline in Body Weight at 6 and 12 Months
6 months
|
102.1 kg
Standard Deviation 16.0
|
99.6 kg
Standard Deviation 19.2
|
|
Change From Baseline in Body Weight at 6 and 12 Months
12 months
|
103.2 kg
Standard Deviation 15.9
|
99.3 kg
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: The number of participants analyzed refers to the number of participants with baseline data
Outcome measures
| Measure |
Placebo
n=75 Participants
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 Participants
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Change From Baseline in Waist Circumference at 6 and 12 Months
Baseline
|
110.3 cm
Standard Deviation 11.4
|
111.2 cm
Standard Deviation 12.5
|
|
Change From Baseline in Waist Circumference at 6 and 12 Months
6 months
|
111.6 cm
Standard Deviation 11.3
|
108.9 cm
Standard Deviation 12.7
|
|
Change From Baseline in Waist Circumference at 6 and 12 Months
12 months
|
111.8 cm
Standard Deviation 10.9
|
108.3 cm
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: Data were not collected
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: Data were not collected
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 months, 12 monthsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Metformin
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=75 participants at risk
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 participants at risk
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/75 • 12 months
|
1.3%
1/76 • 12 months
|
|
Psychiatric disorders
Delusions
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Reproductive system and breast disorders
Uterine pain
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.3%
1/75 • 12 months
|
0.00%
0/76 • 12 months
|
Other adverse events
| Measure |
Placebo
n=75 participants at risk
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Placebo: 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
|
Metformin
n=76 participants at risk
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
6/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Gastrointestinal disorders
Bloating
|
6.7%
5/75 • 12 months
|
7.9%
6/76 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
10.7%
8/75 • 12 months
|
6.6%
5/76 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
15/75 • 12 months
|
36.8%
28/76 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.7%
11/75 • 12 months
|
18.4%
14/76 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
9/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
4/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
10.7%
8/75 • 12 months
|
10.5%
8/76 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.0%
3/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
12.0%
9/75 • 12 months
|
28.9%
22/76 • 12 months
|
|
Gastrointestinal disorders
Stomach pain
|
5.3%
4/75 • 12 months
|
11.8%
9/76 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
8/75 • 12 months
|
3.9%
3/76 • 12 months
|
|
General disorders
Fatigue
|
2.7%
2/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
General disorders
Flu like symptoms
|
20.0%
15/75 • 12 months
|
13.2%
10/76 • 12 months
|
|
Infections and infestations
Bronchial infection
|
5.3%
4/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Infections and infestations
Otitis media
|
5.3%
4/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Infections and infestations
Sinusitis
|
5.3%
4/75 • 12 months
|
7.9%
6/76 • 12 months
|
|
Infections and infestations
Upper respiratory infection
|
25.3%
19/75 • 12 months
|
15.8%
12/76 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
8.0%
6/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Infections and infestations
Vaginal infection
|
5.3%
4/75 • 12 months
|
0.00%
0/76 • 12 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
5/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Investigations
Weight loss
|
8.0%
6/75 • 12 months
|
3.9%
3/76 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/75 • 12 months
|
7.9%
6/76 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
3/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Nervous system disorders
Dizziness
|
2.7%
2/75 • 12 months
|
11.8%
9/76 • 12 months
|
|
Nervous system disorders
Headache
|
17.3%
13/75 • 12 months
|
21.1%
16/76 • 12 months
|
|
Psychiatric disorders
Anxiety
|
5.3%
4/75 • 12 months
|
2.6%
2/76 • 12 months
|
|
Reproductive system and breast disorders
Breast pain
|
10.7%
8/75 • 12 months
|
11.8%
9/76 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.3%
1/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
4/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures, other
|
5.3%
4/75 • 12 months
|
5.3%
4/76 • 12 months
|
|
Vascular disorders
Hypertension
|
6.7%
5/75 • 12 months
|
1.3%
1/76 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place