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Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
A Pilot Trial of Controlled Feeding With Reduced Dietary Protein in Patients With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Receiving Neoadjuvant Chemotherapy
Who can join
Ages 18 to 75 · Women
Full eligibility criteria
Inclusion Criteria: * 18-75 years of age at time of consent * Stage II or III ER+ HER2- breast cancer patients scheduled to receive standard of care neoadjuvant chemotherapy * Willingness to consume study foods exclusively during the 20 days of prescribed diet Exclusion Criteria: * Any food allergy that may result in anaphylactic response or death (due to possible food allergen cross-contamination in the metabolic kitchen) * Habitual low protein intake, less than or equal to 1.0 g per kilogram adjusted body weight, based on a screening dietary habits questionnaire score * Vegans or vegetarians that consume dairy and or eggs * Pregnant or breastfeeding at the time of screening * Significant mental illness presenting challenges to follow directions and consume the controlled protein diet exclusively * Body mass index less than or equal to 18 kilograms over meter squared or greater than 35 kilograms over meter squared * Participating in another study with a diet intervention
About the study
This study will examine if a short-term, reduced protein diet for the 3-day period prior to and on the day of each of the first 4 chemotherapy cycles and 4 days prior to primary breast surgery is well tolerated and adhered to by patients with stage II or III estrogen receptor positive (ER+) human epidermal growth factor receptor negative (HER2-) breast cancer (BC) receiving neoadjuvant chemotherapy (NAC).
What is being tested
- Dietary Protein Intervention (other)
Sponsor: Josephine Connolly-Schoonen · Participants: 15 · Started: Nov 3, 2026
Contact the study team
- Stony Brook Cancer Cetner Clinical Research Office · Phone: 631-728-7425
Official record on ClinicalTrials.gov — NCT07897344
Locations in the U.S.
| New York | Stony Brook Cancer Center, Stony Brook |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.