Breast CancerNCT04717050
Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity
A study testing Progressive combine training (PCT) in people with Breast Cancer and Coronary Artery Disease, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Coronary Artery Disease, Stroke
- What is being tested?
- Progressive combine training (PCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 15 Jun 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women newly diagnosed (Stage I-III) breast cancer.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Are centrally obese with the following criteria[84] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
- Have undergone a lumpectomy or mastectomy.
- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
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- Speak English or Spanish
- Self-identify as Latina
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
- Have not experienced a weight reduction ≥10% within the past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Is not centrally obese as defined above
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
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- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Participates in more than 60 minutes of structured exercise/week
- Is planning reconstructive surgery with flap repair during trial and follow-up period
- Currently smokes
- Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
- Weight reduction ≥ 10% within past 6 months
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
- Progressive combined training (PCT) will be performed in 2 phases:
- supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
- unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
- Attention Control Group: 51 weeks home-based stretching
All participants will undergo seven blood draws and participate in nine testing visits.
Participation is expected to last 12 months for all participants.
It is expected that about 160 people will take part in this research study.
The American Cancer Society is supporting this research study by providing funding for the research study.
- Conditions
- Breast Cancer, Coronary Artery Disease, Stroke, Type2 Diabetes
- Being tested
- Progressive combine training (PCT), Attention Control (AC)
- Keywords
- Breast Cancer, Coronary Artery Disease, Stroke, Type2 Diabetes, Exercise Therapy
- Medical subject headings
- Breast Neoplasms, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive combine training (PCT)Behavioural
8 month exercise program with 4 month follow up.
Attention Control (AC)Behavioural
12 month stretching program
| Study group | Role | What they receive |
|---|---|---|
| Progressive combine training (PCT) | Experimental | Participants will be randomly assigned to Progressive combine training (PCT) group.
Participants will have two (2) baseline tests, then begin a two phase PCT program.
* Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom
* Participants will receive midpoint testing, approximately week 8.
* Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home
* Participants will receive midpoint testing, approximately two months into phase 2.
After the two (2) 16-week phases, participants will be followed for 4 months. Receives: Behavioral: Progressive combine training (PCT) |
| Attention Control (AC) | Active comparator | Participants will be randomly assigned to Attention Control (AC) group.
Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12. Receives: Behavioral: Attention Control (AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Dysregulation (MetD) - Visceral Adiposity
Visceral adiposity (VA) measured by waist to hip ratio (WHR)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start23 Sep 2021
- Primary completion21 Jan 2025
- Study completion15 Jun 2025
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717050
- Sponsor's protocol ID
- 20-221
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2021
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial
- ClinicalTrials.gov ID
- NCT04717050
- Acronym / sponsor ID
- 20-221
- Conditions
- Breast Cancer, Coronary Artery Disease, Stroke, Type2 Diabetes
- Keywords
- Breast Cancer, Coronary Artery Disease, Stroke, Type2 Diabetes, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
- Progressive combined training (PCT) will be performed in 2 phases:
- supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
- unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
- Attention Control Group: 51 weeks home-based stretching
All participants will undergo seven blood draws and participate in nine testing visits.
Participation is expected to last 12 months for all participants.
It is expected that about 160 people will take part in this research study.
The American Cancer Society is supporting this research study by providing funding for the research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive combine training (PCT) | Experimental | Behavioral: Progressive combine training (PCT)Participants will be randomly assigned to Progressive combine training (PCT) group. Participants will have two (2) baseline tests, then begin a two phase PCT program. * Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom * Participants will receive midpoint testing, approximately week 8. * Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home * Participants will receive midpoint testing, approximately two months into phase 2. After the two (2) 16-week phases, participants will be followed for 4 months. |
| Attention Control (AC) | Active comparator | Behavioral: Attention Control (AC)Participants will be randomly assigned to Attention Control (AC) group. Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Women newly diagnosed (Stage I-III) breast cancer.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Are centrally obese with the following criteria[84] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
- Have undergone a lumpectomy or mastectomy.
Key exclusion criteria (13 listed)
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Is not centrally obese as defined above
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 |
|---|---|---|
| Progressive combine training (PCT)8 month exercise program with 4 month follow up. | Behavioural | Progressive combine training (PCT) |
| Attention Control (AC)12 month stretching program | Behavioural | Attention Control (AC) |
Primary outcome
Metabolic Dysregulation (MetD) - Visceral Adiposity
Time frame: 16 weeks
Visceral adiposity (VA) measured by waist to hip ratio (WHR)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christina Dieli-Conwright, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive combine training (PCT) in people with Breast Cancer and Coronary Artery Disease, run by Dana-Farber Cancer Institute 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 18 inclusion and 13 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 10 Jul 2026. 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. 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 10 Jul 2026). 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?
Metabolic Dysregulation (MetD) - Visceral Adiposity (time frame: 16 weeks). 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 10 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.