breast cancer mamma carcinoma
Conditions
Interventions
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, th
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Clinical stage II-III, hormone receptor positive, HER2 negative breast cancer • Detectable and measurable disease (breast and/or lymph nodes) • Age >=18 years old • WHO performance status 0-2 • Ability to read and understand Dutch language, accessibility to a computer with internet connection and independent use of computer
Exclusion criteria
Exclusion criteria: • Patient history of invasive breast cancer or ipsilateral non-invasive breast cancer • Active malignancy in the last 5 years, with the exclusion of basal cell carcinoma or pre-invasive cervical neoplasia/dysplasia. • Body mass index (BMI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Pathologic response-rate (increase in 90-100% tumor-cell loss) and/or pathological complete response (pCR) scored on the surgical tumor resection material. - objective response rate (ORR) assessed by MRI according to Response Evaluation Criteria In Solid Tumors (RECIST)1.1 criteria performed at baseline, after 4 ddAC cycles and at the end of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 3 and 5 year Event free survival (EFS) and overall survival (OS) - Adverse events >=grade 3 (maximum total) difference between treatment arms during ddAC, T and total duration of neoadjuvant chemotherapy. - QoL assessed using validated online questionnaires at T0, T1, T2 and T3. - Cognition assessed by the Amsterdam Cognition Scan (ACS) at T0, T2 and T3. This is a validated online cognitive test battery that can be completed at home. - Local immunomodulation and tumor immunity by analyzing the immune-composition and gene-expression profile using exploratory immune analyses, including multispectral imaging (e.g. Vectra) and transcriptomics using Nanostring in tumor samples taken at baseline (diagnostic), after 4 cycles and resection specimen. | — |
Countries
Netherlands
Outcome results
None listed