DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy for HER2 negative breast cancer

Phase 3

Completed

• Conditions: Breast cancer; mamma carcinoma; 10006291

• Registration Number: NL-OMON44768
• Lead Sponsor: BOOG Study Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

* Female patients with stage II or III breast cancer receiving neoadjuvant 4AC>4T or 3FEC>3T
* Measurable disease (breast and/or lymph nodes)
* HER2 negative core biopsy
* Age *18 years
* WHO performance status 0-2
* Adequate bone marrow function : white blood cells (WBCs) *3.0 x 109/l, neutrophils *1.5 x
10^9/l, platelets *100 x 10^9/l
* Adequate liver function: bilirubin *1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT
*2.5 x UNL, Alkaline Phosphatase *5 x UNL
* Adequate renal function: the calculated creatinine clearance should be *50 mL/min
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements
* Willing to fill in quality of life questionnaires
* Able to read and write in Dutch

Exclusion Criteria

* History of invasive breast cancer or ipsilateral non-invasive breast cancer
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma
of the skin or pre-invasive carcinoma of the cervix.
* Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or
clinically significant arrhythmias
* Diabetes Mellitus
* Body mass index (BMI) < 19 kg/m2
* Pregnancy or lactating
* Significant food allergies which would make the subject unable to consume the food provided (ex:
nuts or soy)
* Any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.
* Medical or psychological condition which in the opinion of the investigator would not permit the
patient to complete the study or sign meaningful informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* The percentage of patients with grade III/IV toxicity to the National Cancer<br /><br>Institute Common Terminology Criteria for Adverse Events version 4.03 (phase<br /><br>II).<br /><br>* The percentage of pathological complete response according Miller and Payne<br /><br>(phase III). </p><br>