Early-stage Breast CancerNCT03946423
BAriaTric Surgery After Breast Cancer Treatment (BATS)
A study testing Bariatric Surgery with Sleeve Gastrectomy and Lifestyle Intervention in people with Early-stage Breast Cancer and Obesity, run by Masonic Cancer Center, University of Minnesota.
Trial summary
This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study… Read more about this study
- Who is it for?
- Ages 18 to 67 years, women only
- Conditions the study is for
- Early-stage Breast Cancer, Obesity
- What is being tested?
- Bariatric Surgery with Sleeve Gastrectomy and Lifestyle Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Feb 2028
- Phase
- Interventional
- 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 18 to 67 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer in the previous 10 years and currently disease free.
- Completion of breast cancer treatment (radiation, chemotherapy) at least > 6 months prior to enrollment
- Body mass index (BMI) of ≥ 35 kg/m2, but < 50 kg/m2.
- 18 through 67 years of age at enrollment
- Deemed healthy enough to undergo bariatric surgery, if assigned intervention, as determined by a surgeon and documented in the medical record.
- Must have insurance coverage with no exclusion for obesity related treatment or management of obesity related surgical complications - in general insurance coverage is available for persons with a BMI ≥ 35 kg/m2.
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- Anticipated ability to abide by study requirements demonstrated in part by, but not limited to, successful completion of run-in assessments.
- Willingness to accept randomization into either interventional group.
- Provides voluntary written consent prior to performance of any research related activities.
Who cannot join
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery or lifestyle would not be safe.
- 12-lead EKG indicating that surgery would not be safe.
- Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
- History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
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- Gastric or duodenal ulcer in the past six months.
- History of intra-abdominal sepsis except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment.
- Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
- Currently pregnant or nursing, or planning to become pregnant in the next 15 months.
- History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
- Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
- Deemed not an acceptable candidate by a trained psychologist.
- Current participation in a conflicting research protocol.
- Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
- Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.
- Any history of dysphagia.
About this study
Official title: BAriaTric Surgery After Breast Cancer Treatment (BATS) - A Randomized Trial of Sleeve Gastrectomy Versus Lifestyle Intervention in Women Diagnosed With Early Stage Breast and With a BMI of ≥ 35
This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study plan for 1 year. If there is successful enrollment in this study, the plan is to use what is learned in this study to design a larger, longer-term clinical trial to look at the effect of weight loss and incidence of cancer recurrence.
- Conditions
- Early-stage Breast Cancer, Obesity
- Being tested
- Bariatric Surgery with Sleeve Gastrectomy, Lifestyle Intervention
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Surgery with Sleeve GastrectomyProcedure or surgery
Standard of care bariatric surgery with sleeve gastrectomy
Lifestyle InterventionBehavioural
All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy & Lifestyle Intervention | Experimental | Not described Receives: Procedure: Bariatric Surgery with Sleeve Gastrectomy; Behavioral: Lifestyle Intervention |
| Lifestyle Intervention | Active comparator | Not described Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Weight Loss Intervention
Feasibility for women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but < 50 kg/m2.
Measured: 1 Year
Acceptability of Weight Loss Intervention
Acceptability of women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but < 50 kg/m2.
Measured: 1 Year
Secondary outcomes (4)
Weight Loss
Percent body mass weight loss
Measured: 1 Year
Breast Cancer Recurrence
Incidence of breast cancer recurrence
Measured: 1 Year
Cancer Related Mortality
Incidence of cancer related mortality
Measured: 1 Year
Overall Mortality
Incidence of overall mortality
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startJun 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Not moving forward with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Blaes, MD, Principal investigator, University of Minnesota, Division of Hematology, Oncology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946423
- Sponsor's protocol ID
- 2018LS148
- Status last verified
- Jul 2026
- First submitted
- 8 May 2019
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAriaTric Surgery After Breast Cancer Treatment (BATS) - A Randomized Trial of Sleeve Gastrectomy Versus Lifestyle Intervention in Women Diagnosed With Early Stage Breast and With a BMI of ≥ 35
- ClinicalTrials.gov ID
- NCT03946423
- Acronym / sponsor ID
- 2018LS148
- Conditions
- Early-stage Breast Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not moving forward with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 May 2019 (actual)
- 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.
This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study plan for 1 year. If there is successful enrollment in this study, the plan is to use what is learned in this study to design a larger, longer-term clinical trial to look at the effect of weight loss and incidence of cancer recurrence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy & Lifestyle Intervention | Experimental | Procedure: Bariatric Surgery with Sleeve Gastrectomy, Behavioral: Lifestyle Intervention |
| Lifestyle Intervention | Active comparator | Behavioral: Lifestyle Intervention |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of breast cancer in the previous 10 years and currently disease free.
- Completion of breast cancer treatment (radiation, chemotherapy) at least > 6 months prior to enrollment
- Body mass index (BMI) of ≥ 35 kg/m2, but < 50 kg/m2.
- 18 through 67 years of age at enrollment
- Deemed healthy enough to undergo bariatric surgery, if assigned intervention, as determined by a surgeon and documented in the medical record.
Key exclusion criteria (17 listed)
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery or lifestyle would not be safe.
- 12-lead EKG indicating that surgery would not be safe.
- Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
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 |
|---|---|---|
| Bariatric Surgery with Sleeve GastrectomyStandard of care bariatric surgery with sleeve gastrectomy | Procedure or surgery | Sleeve Gastrectomy & Lifestyle Intervention |
| Lifestyle InterventionAll participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance. | Behavioural | Lifestyle Intervention, Sleeve Gastrectomy & Lifestyle Intervention |
Primary outcome
Feasibility of Weight Loss Intervention
Time frame: 1 Year
Feasibility for women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but < 50 kg/m2.
Acceptability of Weight Loss Intervention
Time frame: 1 Year
Acceptability of women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but < 50 kg/m2.
4 secondary outcomes
Weight Loss
Time frame: 1 Year
Breast Cancer Recurrence
Time frame: 1 Year
Cancer Related Mortality
Time frame: 1 Year
Overall Mortality
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Anne Blaes, MD principal investigator
University of Minnesota, Division of Hematology, Oncology and Transplantation
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery with Sleeve Gastrectomy and Lifestyle Intervention in people with Early-stage Breast Cancer and Obesity, run by Masonic Cancer Center, University of Minnesota.
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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of Weight Loss Intervention (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 9 Jul 2026.