Trial Outcomes & Findings for Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation (NCT NCT00930579)
NCT ID: NCT00930579
Last Updated: 2022-10-20
Results Overview
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline, up to 4 weeks
Results posted on
2022-10-20
Participant Flow
The investigator conducted an open-label, single-arm, presurgical trial with metformin at Columbia University Medical Center (CUMC) in New York, New York. Between October 2009 and August 2011.
Participant milestones
| Measure |
Metformin
Women with newly diagnosed early invasive breast cancer received doses of the study drug, Metformin, prior to their scheduled surgery. Participants received 1500mg of metformin per day - 500mg in the morning, and 1000mg in the evening.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Metformin
Women with newly diagnosed early invasive breast cancer received doses of the study drug, Metformin, prior to their scheduled surgery. Participants received 1500mg of metformin per day - 500mg in the morning, and 1000mg in the evening.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Discontinued due to rescheduled surgery
|
1
|
Baseline Characteristics
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Baseline characteristics by cohort
| Measure |
Metformin
n=33 Participants
Women with newly diagnosed early invasive breast cancer received doses of the study drug, Metformin, for at least two weeks before their scheduled surgery. Participants received 1500mg of metformin per day- 500mg in the morning, and 1000mg in the evening.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
28 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 4 weeksPopulation: Of the evaluable metformin-treated patients, 33 participants were included in the analysis.
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
Outcome measures
| Measure |
Metformin
n=33 Participants
Women with newly diagnosed early invasive breast cancer received doses of the study drug, Metformin, for at least two weeks prior to surgery. Participants received 1500 mg of Metformin per day- 500mg in the morning, and 1000 mg in the evening.
|
|---|---|
|
Tumor Proliferation in Tumor Specimens
Premetformin Tumor Sample
|
2.17 percentage of ki-67 positive cells
Standard Deviation 1.60
|
|
Tumor Proliferation in Tumor Specimens
Post Metformin Tumor Sample
|
2.165 percentage of ki-67 positive cells
Standard Deviation 1.67
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=33 participants at risk
Women with newly diagnosed early invasive breast cancer will receive Metformin
Metformin: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
|
|---|---|
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Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Flatulence
|
45.5%
15/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
11/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.3%
10/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
General disorders
Fatigue
|
30.3%
10/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Nervous system disorders
Dizziness
|
24.2%
8/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Nervous system disorders
Headache
|
24.2%
8/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal Distension
|
21.2%
7/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.2%
7/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Nervous system disorders
Taste Alteration
|
18.2%
6/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Investigations
Dry Mouth
|
15.2%
5/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Constipation
|
12.1%
4/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Investigations
Heartburn
|
9.1%
3/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
2/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
2/33 • Up to 4 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as the ClinicalTrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place