Breast Cancer Trial, Recruiting NCT04469296 Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04469296
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 18 to 80 years old
  • People diagnosed with a confirmed invasive breast cancer (not spread to other parts of the body), at stage I, II, or III, that is hormone receptor positive (ER and/or PR positive) and HER2 negative
  • People who have not yet received any treatment for their current breast cancer
  • People whose cancer is planned to be treated with surgery first
  • People with a body mass index (BMI) between 18.5 and 30 (for those aged up to 70), or between 21 and 30 (for those aged 70 to 80)
  • People aged 70 or over who score above 14 on a specific health questionnaire called the Oncodage G8 (if the score is 14 or below, a specialist review of diet safety would be required first)
  • People with little or no use of alcohol (no more than 2 drinks per day or 10 per week), tobacco (only very occasional use or stopped for at least 6 months), drugs, or electronic cigarettes
  • People who are generally well and able to carry out daily activities with little or no limitation (what doctors call performance status 0 or 1)
  • People whose fasting blood tests show healthy levels of blood cells, liver function, kidney function, cholesterol, blood sugar, and electrolytes, as assessed by the trial site
  • People with a normal heart reading (ECG) showing a QTc interval of 450 milliseconds or less
  • People who are able to understand the study and are willing to give written consent to take part

Who may not be able to join:

  • People with a metabolic disease or another condition that would affect how the body processes nutrients or energy
  • People who are high-level or elite athletes
  • People who have lost weight without trying — 5% or more of body weight in the last month, or 10% or more over the last 6 months
  • People who have been taking dietary supplements not prescribed for a confirmed deficiency in the past month
  • People following a restricted or unbalanced diet (such as vegan, very low calorie, or very high or low protein diets) in the past month
  • People who have practised any form of fasting in the past 3 months
  • People taking corticosteroid medications that cannot be stopped, or that have not been stopped for at least 2 weeks before the trial
  • People with diabetes (type 1 or type 2, with or without insulin)
  • People with high cholesterol that requires medication
  • People whose breast cancer is specifically of the invasive lobular type
  • People who are pregnant or currently breastfeeding
  • People who have taken part in another clinical trial involving an experimental treatment within the past 30 days
  • People under legal guardianship or conservatorship
  • People not enrolled in a social protection or health insurance system (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Veronique D'HONDT, MD, ICM Val d'Aurelle

Phone: 04 67 61 31 02

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Registry
ClinicalTrials.gov
Start date
18 May 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov