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Fasting Mimicking Diet 3 days before and the day of neoadjuvant chemotherapy (ddAC, T)

Standard neoadjuvant chemotherapy (ddAC, T)

Fasting mimicking diet by L-Nutra, a 4-day low caloric, low protein, vegetarian diet 3 days prior to and the day of neoadjuvant chemotherapy administration. The FMD will take place every 4 weeks, thus in total 5 times (2x during ddAC, 3x during Paclitaxel) during the neoadjuvant chemotherapy.

Fasting Mimicking diet program

Judith R Kroep, PhD

In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs \<90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

STF during neadjuvant chemotherapy aiming to improve the chemotherapy efficacy and decline the side effects in patients with stage II-III HR+, HER2- breast cancer

Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer

DIRECT-2: Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- Breast Cancer

Genetic and/or epigenetic analysis will be performed on blood samples by for example PCR and/or GWAS technique.

Validated online questionnaires take place at baseline, after 4 ddAC cycles, before surgery and 6 months after surgery.

online questionnaires take place at baseline, before surgery and 6 months after surgery.

By analyzing the immune-composition and gene-expression profile using multispectral Vectra imaging and Nanostring analyses respectively, in tumor samples taken at baseline (diagnostic), after 4 cycles and resection specimen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer	NCT05503108	Fasting Mimicki... HER2-negative B... Hormone Recepto... Pathological Co... Objective Respo... Neoadjuvant Che...	Fasting Mimicki...	18 Years -	Leiden University Medical Center
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer	NCT05503108	Fasting Mimicki... HER2-negative B... Hormone Recepto... Pathological Co... Objective Respo... Neoadjuvant Che...	Fasting Mimicki...	18 Years -	Leiden University Medical Center

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