DIRECT-2: Fasting mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- breast cancer

Phase 3

Completed

Conditions: breast cancer
mamma carcinoma
10006291

Registration Number: NL-OMON51480

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

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

• 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) < 18.5 kg/m2
• Pregnancy or lactating
• Food allergy for ingredients of FMD (nuts, soy, honey)
• A metabolic condition affecting gluconeogenesis or adaptation to periodic
fasting. (Diabetes Mellitus for example)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pathologic response-rate (increase in 90-100% tumor-cell loss) and/or<br /><br>pathological complete response (pCR) scored on the surgical tumor resection<br /><br>material.<br /><br>- objective response rate (ORR) assessed by MRI according to Response<br /><br>Evaluation Criteria In Solid Tumors (RECIST)1.1 criteria performed at baseline,<br /><br>after 4 ddAC cycles and at the end of chemotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 3 and 5 year Event free survival (EFS) and overall survival (OS)<br /><br>- Adverse events >=grade 3 (maximum total) difference between treatment arms<br /><br>during ddAC, T and total duration of neoadjuvant chemotherapy.<br /><br>- QoL assessed using validated online questionnaires at T0, T1, T2 and T3.<br /><br>- Cognition assessed by the Amsterdam Cognition Scan (ACS) at T0, T2 and T3.<br /><br>This is a validated online cognitive test battery that can be completed at home.<br /><br>- Local immunomodulation and tumor immunity by analyzing the immune-composition<br /><br>and gene-expression profile using exploratory immune analyses, including<br /><br>multispectral imaging (e.g. Vectra) and transcriptomics using Nanostring in<br /><br>tumor samples taken at baseline (diagnostic), after 4 cycles and resection<br /><br>specimen. </p><br>