Short-Term Low-Protein Diet Around Chemotherapy for ER+/HER2- Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines whether a brief, controlled reduction in dietary protein around the first four cycles of neoadjuvant chemotherapy is tolerable and feasible for patients with stage II-III ER+/HER2- breast cancer. Participants will follow a prescribed low-protein diet for 20 days, including 3 days before and on the day of each of the first four chemo cycles and 4 days before surgery. The trial explores adherence, safety, and potential hints of impact on treatment delivery and tumor response, within a real-world clinical setting at Stony Brook Cancer Center. The approach builds on preclinical data suggesting that adjusting amino acid availability may influence tumor biology and treatment efficacy. Outcomes focus on feasibility and safety rather than definitive efficacy signals.

Why it matters

Who can join: the full rules

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

Where it's running

• Stony Brook Cancer Center
  Stony Brook, New York, United States Recruiting

Study contacts

• Principal investigator: Josephine Connolly-Schoonen, PhD, RD — Stony Brook University - Family, Population and Preventive Medicine
• Study coordinator: Stony Brook Cancer Cetner Clinical Research Office
• Email: CancerClinicalTrials@stonybrookmedicine.edu
• Phone: 631-728-7425

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.