An interventional study of Exercise and Medical Nutrition in Triple Negative Breast Cancer, sponsored by Yale University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.
Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based.
Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition.
The primary outcome is the pathologic complete response.
Researchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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.
Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.
Behavioral: Exercise and Medical Nutrition
Contact limited to study assessments.
10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.
Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0)
Time frame: Post breast cancer surgery, an average of 6 months
Residual Cancer Burden (RCB)
Residual Cancer Burden (RCB) is a continuous pCR measure.
Time frame: Post breast cancer surgery, an average of 6 months
Healthy Eating Index (HEI)
Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Physical activity
Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Patient reported toxicities
Participants will be asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, 2-months, 4-months and the end of chemotherapy.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Physical function
Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Fatigue
Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Neuropathy
Participants will be asked to complete the Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-Ntx).
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Malnutrition
Participants will be asked to complete the Patient-Generated Subjective Global Assessment (PG-SGA).
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Aerobic capacity
Participants will be asked to complete a 6-minute walk test.
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Lean mass
Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Percent fat
Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan
Time frame: Baseline to end of first line chemotherapy, on average 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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