Trial Outcomes & Findings for Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By Surgery (NCT NCT00984490)

Results Overview

Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

baseline and between 8-23 days

Results posted on

2024-02-01

Participant Flow

This study recruited patients from September 24, 2009 through June 28, 2011.

Five patients enrolled on this study during the first nine months. Accrual continued to be slow causing its premature closing.

Participant milestones

Participant milestones
Measure	Metformin Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=5 Participants Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	45 years STANDARD_DEVIATION 1 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: baseline and between 8-23 days

Population: No Ki67 levels were determined. This clinical trial was closed due to slow accrual

Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 23 days

Population: No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.

Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin

Outcome measures

Outcome data not reported

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Metformin n=5 participants at risk Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
Gastrointestinal disorders diarrhea	80.0% 4/5 • Number of events 5
Gastrointestinal disorders nausea	40.0% 2/5 • Number of events 2
Injury, poisoning and procedural complications vomiting	20.0% 1/5 • Number of events 1
Investigations weight loss	20.0% 1/5 • Number of events 1

Additional Information

Ingrid Mayer, MD

Vanderbilt-Ingram Cancer Center

Phone: 615-936-2033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place