Breast NeoplasmsNCT01302379

Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

A study testing Metformin, Lifestyle intervention and Standard printed dietary guidelines in people with Breast Neoplasms, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Metformin, Lifestyle intervention and Standard printed dietary guidelines
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 333 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

BMI at least 25.0 kg/m2
Diagnosed with Stage I, II, or III breast cancer within past 5 years
Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
Not scheduled for or currently undergoing chemotherapy
Accessible geographically and by telephone
Able to communicate dietary and physical activity data via telephone
If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
Post-menopausal at diagnosis

Who cannot join

Preliminary bloodwork outside of specified ranges
Evidence of renal insufficiency, liver disease, or congestive heart failure
Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
Recent initiation (< 3 months ago) of thiazides or β-blockers
Taking insulin or other antidiabetic drug
Other primary or recurrent invasive cancer in past 10 years
Unable to commit to study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

Moores UCSD Cancer Center
La Jolla, California, 92093

Other trials in United States

About this study

Official title: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.

Conditions: Breast Neoplasms
Being tested: Metformin, Placebo, Lifestyle intervention, Standard printed dietary guidelines
Keywords: Obesity, Survival, Weight loss, Metformin, Biological markers
Medical subject headings: Breast Neoplasms, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
PlaceboDrug
Also called Sugar pill
Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle interventionBehavioural
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Standard printed dietary guidelinesBehavioural
Set of standard health education materials provided to participants at single time point (immediately after randomization)

Study groups in NCT01302379
Study group	Role	What they receive
Metformin + lifestyle intervention	Active comparator	Not described Receives: Drug: Metformin; Behavioral: Lifestyle intervention
Placebo + lifestyle intervention	Active comparator	Not described Receives: Drug: Placebo; Behavioral: Lifestyle intervention
Metformin + standard dietary guidelines	Active comparator	Not described Receives: Drug: Metformin; Behavioral: Standard printed dietary guidelines
Placebo + standard dietary guidelines	Placebo comparator	Not described Receives: Drug: Placebo; Behavioral: Standard printed dietary guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin
Insulin measured as percent change from baseline
Measured: change from baseline to 6 months
Glucose
Glucose measured as percent change from baseline
Measured: change from baseline to 6 months
C-reactive Protein
C-reactive protein measured as percent change from baseline
Measured: change from baseline to 6 months
Bioavailable Testosterone
Bioavailable testosterone measured as percent change from baseline
Measured: change from baseline to 6 months
Serum Hormone Binding Globulin
Serum hormone binding globulin measured as percent change from baseline
Measured: change from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2016

First posted24 Feb 2011 (estimated)
Study startAug 2011
Primary completionDec 2015
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: Main effects of the factorial design were the planned primary analysis and what the study was powered on.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01302379
Sponsor's protocol ID: U54 CA155435-01 Project 3
Other IDs: U54CA155435-01
Status last verified: May 2020
First submitted: 23 Feb 2011
Last updated: 5 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bellerba F, Chatziioannou AC, Jasbi P, Robinot N, Keski-Rahkonen P, Trolat A, Vozar B, Hartman SJ, Scalbert A, Bonanni B, Johansson H, Sears DD, Gandini S. Metabolomic profiles of metformin in breast cancer survivors: a pooled analysis of plasmas from two randomized placebo-controlled trials. J Transl Med. 2022 Dec 29;20(1):629. doi: 10.1186/s12967-022-03809-6.
PubMed 36581893
Nwanaji-Enwerem JC, Chung FF, Van der Laan L, Novoloaca A, Cuenin C, Johansson H, Bonanni B, Hubbard AE, Smith MT, Hartman SJ, Cardenas A, Sears DD, Herceg Z. An epigenetic aging analysis of randomized metformin and weight loss interventions in overweight postmenopausal breast cancer survivors. Clin Epigenetics. 2021 Dec 17;13(1):224. doi: 10.1186/s13148-021-01218-y.
PubMed 34920739

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT01302379
Acronym / sponsor ID: U54 CA155435-01 Project 3
Conditions: Breast Neoplasms
Keywords: Obesity, Survival, Weight loss, Metformin, Biological markers
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: Aug 2011
Primary completion: Dec 2015 (actual)
Study completion: Dec 2016 (actual)
First posted: 24 Feb 2011 (estimated)
Results: Posted 5 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Main effects of the factorial design were the planned primary analysis and what the study was powered on.

Arm	Type	Receives
Metformin + lifestyle intervention	Active comparator	Drug: Metformin, Behavioral: Lifestyle intervention
Placebo + lifestyle intervention	Active comparator	Drug: Placebo, Behavioral: Lifestyle intervention
Metformin + standard dietary guidelines	Active comparator	Drug: Metformin, Behavioral: Standard printed dietary guidelines
Placebo + standard dietary guidelines	Placebo comparator	Drug: Placebo, Behavioral: Standard printed dietary guidelines

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

BMI at least 25.0 kg/m2
Diagnosed with Stage I, II, or III breast cancer within past 5 years
Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
Not scheduled for or currently undergoing chemotherapy
Accessible geographically and by telephone

Key exclusion criteria (7 listed)

Preliminary bloodwork outside of specified ranges
Evidence of renal insufficiency, liver disease, or congestive heart failure
Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
Recent initiation (< 3 months ago) of thiazides or β-blockers
Taking insulin or other antidiabetic drug

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
MetforminWeek 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time	Drug	Metformin + lifestyle intervention, Metformin + standard dietary guidelines
PlaceboAlso: Sugar pillWeek 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time	Drug	Placebo + lifestyle intervention, Placebo + standard dietary guidelines
Lifestyle interventionTelephone-based lifestyle intervention (dietary change and physical activity) for weight loss.	Behavioural	Metformin + lifestyle intervention, Placebo + lifestyle intervention
Standard printed dietary guidelinesSet of standard health education materials provided to participants at single time point (immediately after randomization)	Behavioural	Metformin + standard dietary guidelines, Placebo + standard dietary guidelines

Primary outcome

Insulin
Time frame: change from baseline to 6 months
Insulin measured as percent change from baseline
Glucose
Time frame: change from baseline to 6 months
Glucose measured as percent change from baseline
C-reactive Protein
Time frame: change from baseline to 6 months
C-reactive protein measured as percent change from baseline
Bioavailable Testosterone
Time frame: change from baseline to 6 months
Bioavailable testosterone measured as percent change from baseline
Serum Hormone Binding Globulin
Time frame: change from baseline to 6 months
Serum hormone binding globulin measured as percent change from baseline

Results and safety

Results posted to the registry on 5 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin + Lifestyle Intervention	83	76
Placebo + Lifestyle Intervention	83	78
Metformin + Standard Dietary Guidelines	84	80
Placebo + Standard Dietary Guidelines	83	79

Primary outcome: Insulin

Time frame: change from baseline to 6 months. Least squares mean (95% Confidence Interval). Unit: percent change from baseline

Measure	Metformin + Lifestyle Intervention n = 83	Placebo + Lifestyle Intervention n = 83	Metformin + Standard Dietary Guidelines n = 84	Placebo + Standard Dietary Guidelines n = 83
Value	-21.8 (-29.7 to -13.0)	-17.7 (-25.9 to -8.6)	-13.2 (-21.7 to -3.7)	-1.1 (-10.9 to 9.8)

Population analysed: Obese or overweight postmenopausal breast cancer survivors

Primary outcome: Glucose

Time frame: change from baseline to 6 months. Least squares mean (95% Confidence Interval). Unit: percent change from baseline

Measure	Metformin + Lifestyle Intervention n = 83	Placebo + Lifestyle Intervention n = 83	Metformin + Standard Dietary Guidelines n = 84	Placebo + Standard Dietary Guidelines n = 83
Value	-1.2 (-3.9 to 1.5)	-2.3 (-4.9 to 0.4)	-1.6 (-4.2 to 1.0)	2.0 (-0.7 to 4.8)

Population analysed: Obese or overweight postmenopausal breast cancer survivors

Primary outcome: C-reactive Protein

Time frame: change from baseline to 6 months. Least squares mean (95% Confidence Interval). Unit: percent change from baseline

Measure	Metformin + Lifestyle Intervention n = 83	Placebo + Lifestyle Intervention n = 83	Metformin + Standard Dietary Guidelines n = 84	Placebo + Standard Dietary Guidelines n = 83
Value	-21.4 (-38.9 to 1.0)	-6.7 (-27.4 to 19.7)	-9.2 (-29.0 to 16.1)	5.9 (-17.4 to 35.7)

Population analysed: Obese or overweight postmenopausal breast cancer survivors

Primary outcome: Bioavailable Testosterone

Time frame: change from baseline to 6 months. Least squares mean (95% Confidence Interval). Unit: percent change from baseline

Measure	Metformin + Lifestyle Intervention n = 83	Placebo + Lifestyle Intervention n = 83	Metformin + Standard Dietary Guidelines n = 84	Placebo + Standard Dietary Guidelines n = 83
Value	-13.7 (-20.3 to -6.5)	-4.5 (-11.7 to 3.4)	-11.1 (-17.8 to -3.9)	-1.3 (-8.7 to 6.7)

Population analysed: Obese or overweight postmenopausal breast cancer survivors

Adverse events

Time frame: Across the 6 month intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin vs Placebo	5 of 333 (1.5%)	1 of 333 (0.3%)	Not reported
Lifestyle vs. Control	5 of 333 (1.5%)	1 of 333 (0.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36581893Bellerba F, Chatziioannou AC, Jasbi P, Robinot N, Keski-Rahkonen P, Trolat A, Vozar B, Hartman SJ, Scalbert A, Bonanni B, Johansson H, Sears DD, Gandini S. Metabolomic profiles of metformin in breast cancer survivors: a pooled analysis of plasmas from two randomized placebo-controlled trials. J Transl Med. 2022 Dec 29;20(1):629. doi: 10.1186/s12967-022-03809-6.
Derived from this study: PubMed 34920739Nwanaji-Enwerem JC, Chung FF, Van der Laan L, Novoloaca A, Cuenin C, Johansson H, Bonanni B, Hubbard AE, Smith MT, Hartman SJ, Cardenas A, Sears DD, Herceg Z. An epigenetic aging analysis of randomized metformin and weight loss interventions in overweight postmenopausal breast cancer survivors. Clin Epigenetics. 2021 Dec 17;13(1):224. doi: 10.1186/s13148-021-01218-y.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Metformin, Lifestyle intervention and Standard printed dietary guidelines in people with Breast Neoplasms, run by University of California, San Diego at 1 site in United States.

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 8 inclusion and 7 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 5 Jun 2020. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Insulin (time frame: change from baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302379, which also lists 2 linked publications.

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 5 Jun 2020.