An interventional study of TOPS Classes in Breast Cancer and Weight Loss, sponsored by Duke University. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
Among 69 studies in Breast Neoplasms by Duke University — 8 open to participants now, 11 under way, none of them phase 3. Breast Neoplasms · Duke University.
Among the 69 studies in Breast Neoplasms by Duke University, this one is the 40th largest by planned enrollment of the 58 interventional ones that give a count, is one of 7 that started in 2026, is one of 39 with no phase, reaches primary completion later than 4 of the 10 other live ones, and was the 63rd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →8 of the 69 studies in Breast Neoplasms by Duke University are open now, in 1 country. Recruiting first, the newest first:
Duke University · Sites in United States
Duke University · Sites in United States
Duke University · Sites in United States
Duke University · Sites in United States
Duke University · Sites in United States
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 21 Years to 90 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
69 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 13
First in 1997; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 25 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 40 across the 58 interventional studies, 61 across the 10 observational. Of the 54 that completed or were terminated, 12 (22%) have results posted.
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Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
3 of the studies in Breast Neoplasms by Duke University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07426952Duke UniversityWeight Management After Cancer for Survivors in Rural Communities | 2026-12-31 |
| NCT06983691Duke UniversityPatient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib | 2027-03 |
| NCT06658912Duke UniversityPlanning Grant for TOPS for Breast Cancer Survivors | 2027-09-30 |
Among the 69 studies in Breast Neoplasms by Duke University, from their registry updates:
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The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.
The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.
This ClinicalTrials.gov record is specific to the second part of the study.
The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.
The information gathered from these groups will be used to improve the materials which lead to part two of the study.
The second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.
For the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.
After 6 months, participants will be asked to join a TOPS chapter in their community. The study team will help them local a chapter that is convenient for them. They must attend these classes for another 6 months. Total time in this portion of the study will be approximately 12 months.
While on study, in addition to measuring their weight and blood pressure via the Bluetooth devices, the study team asks that participants also have their blood collected. Participants will have to go to their local LabCorp facility to have blood drawn at baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.
This ClinicalTrials.gov record is specific to the second part of the study.
Aim 2 Inclusion Criteria:
Aim 2 Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: TOPS Classes
Attend Dietician-Led Sessions
Number of invitations sent through the electronic health record to get 25 individuals consented to the study
Time frame: 1-2 months
Percentage of TOPS group session attendance
This will be calculated as number of sessions attended divided by total number of sessions offered
Time frame: 12 months
Number of participants who stay in the study
Time frame: 3 months, 6 months, 9 months, 12 months
Number of participants who transition from the initiation phase to the maintenance phase
Time frame: 12 months
Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase
Time frame: 9 months, 12 months
Percent of Weight Loss
Time frame: Up to 12 Months
Cardiovascular Disease (CVD) risk factors as measured by blood pressure
Time frame: up to 12 months
Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c
Time frame: up to 12 months
Cardiovascular Disease (CVD) risk factors as measured by glucose
Time frame: up to 12 months
Percentage of participants who get blood drawn
Time frame: Baseline, 3 months, 6 months,12 months
Quality of Life (QOL) as measured by survey
Time frame: up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 13 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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