Breast CancerPhase 2NCT00909506
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
A Phase 2 study testing Metformin in people with Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS < 126
- From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
- No drug use except Tamoxifen
- Normal OTPT \& Serum creatinine (<=ULN)
- ECOG performance status 0-2 or Karnofsky PS 60-100%
- Life expectancy > 12
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- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Pregnancy(-) \& without plan for pregnancy
- Sign a written informed consent form
Who cannot join
- Type I or II DM or concurrent use of DM control agents
- Prior use of Metformin
- Hypoglycemia (FBS< 70 with clinical symptom)
- Concurrent investigational or commercial agents
- Other diet or drug intervention for weight loss
- Concurrent use of steroid
Show all 16Show fewer
- Abnormal liver and/or renal function
- Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
- Ongoing or active infection
- lactic acidosis
- Pregnancy or ongoing breast feeding
- Anorexia, bulimia, nausea due to other disease for longer than 1 month
- Allergies or allergic reactions attributed to oral medications
- Inability to swallow or digest oral medications
- Physical or psychiatric illness that would limit compliance with study protocol
- Participants in other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.
In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
- Conditions
- Breast Cancer
- Being tested
- Placebo, Metformin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Control: Receive placebo pill once every evening on 1~2 weeks.
Receive placebo pill in every morning and evening on 3~24 weeks (twice a day).
MetforminDrug
Metformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1~2 weeks.
Receive placebo pill in every morning and oral metformin 500 mg in every evening on 3~24 weeks.
MetforminDrug
Metformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1~2 weeks. (Dose-escalate)
Receive oral metformin 500 mg in every morning and evening on 3~24 weeks (metformin 500 mg * twice a day = 1000 mg per day).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Metformin 500 mg/d | Active comparator | Metformin 500 mg/d Receives: Drug: Metformin |
| Metformin 1000 mg/d | Active comparator | Metformin 1000 mg/d Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wonshik Han, M.D., Ph.D., Principal investigator, Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909506
- Sponsor's protocol ID
- adjuvant metformin for BC
- Status last verified
- Sep 2010
- First submitted
- 27 May 2009
- Last updated
- 29 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00909506
- Acronym / sponsor ID
- adjuvant metformin for BC
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.
In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Metformin 500 mg/d | Active comparator | Drug: MetforminMetformin 500 mg/d |
| Metformin 1000 mg/d | Active comparator | Drug: MetforminMetformin 1000 mg/d |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS < 126
- From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
- No drug use except Tamoxifen
- Normal OTPT \& Serum creatinine (<=ULN)
- ECOG performance status 0-2 or Karnofsky PS 60-100%
Key exclusion criteria (16 listed)
- Type I or II DM or concurrent use of DM control agents
- Prior use of Metformin
- Hypoglycemia (FBS< 70 with clinical symptom)
- Concurrent investigational or commercial agents
- Other diet or drug intervention for weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboControl: Receive placebo pill once every evening on 1~2 weeks. Receive placebo pill in every morning and evening on 3~24 weeks (twice a day). | Drug | Placebo |
| MetforminMetformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1~2 weeks. Receive placebo pill in every morning and oral metformin 500 mg in every evening on 3~24 weeks. | Drug | Metformin 500 mg/d |
| MetforminMetformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1~2 weeks. (Dose-escalate) Receive oral metformin 500 mg in every morning and evening on 3~24 weeks (metformin 500 mg * twice a day = 1000 mg per day). | Drug | Metformin 1000 mg/d |
Primary outcome
Weight loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wonshik Han, M.D., Ph.D. principal investigator
Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.