Printed from Voxsanity (voxsanity.com.au) — NCT06787118 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Breast Cancer Trial, Not Yet Recruiting
NCT06787118
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- People who are able to understand, agree to, and sign a consent form before any trial-related procedures take place, and who are willing to follow the trial schedule and procedures.
- People who are covered by a social security or health insurance system.
- People who are 18 years of age or older at the time of joining the trial.
- People who have been confirmed through a tissue sample (biopsy) to have invasive breast cancer at Stage I, II, or III.
- People whose breast cancer tests positive for hormone receptors (oestrogen receptor and/or progesterone receptor), with at least 10% of cancer cells showing this.
- People who have been taking one of three standard hormone-blocking medicines (anastrozole, exemestane, or letrozole) at the standard dose for at least 21 days but no more than 36 months before joining the trial; women who have not yet gone through menopause may be eligible if they are taking one of these medicines along with a treatment to suppress ovarian function.
- People who, if it was recommended for them, have already completed chemotherapy before joining the trial.
- People who, if it was recommended for them, have already completed radiotherapy before joining the trial.
- People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (where 0 means fully active and 2 means limited in physical activity but able to care for oneself).
- People who report joint pain that scores 4 or higher out of 10 on a standard pain questionnaire, measured within the 7 days before registering for the trial.
- People who are willing and able to attend scheduled visits, follow treatment plans, and complete required tests and procedures.
- Women who could potentially become pregnant must have a negative pregnancy test (urine or blood) within 14 days before being assigned to a treatment group.
- Women who could potentially become pregnant must be willing to use highly effective contraception during the trial and for 3 months after stopping treatment; sexual partners who are male are also strongly advised to use a condom during this period (including men who have had a vasectomy), and are strongly advised not to father a child during this time.
- Acceptable contraception methods for women include: complete abstinence (if this is consistent with the person's usual lifestyle); surgical sterilisation such as removal of both ovaries, full hysterectomy, or tubal ligation performed at least 6 weeks before starting the trial; or placement of an intrauterine device (IUD).
- Note: hormonal contraception (such as the pill, patch, injection, or implant) and hormonal replacement therapy are not permitted in this trial.
- People who have blood and organ function test results that meet the required levels, including sufficient white blood cells, platelets, and haemoglobin, as well as adequate kidney function, liver enzyme levels within acceptable limits, and normal bilirubin levels (with an exception for people with a confirmed condition called Gilbert's Syndrome).
- People whose blood clotting levels fall within the required range (or within the safe treatment range if already on blood-thinning medication).
- People whose blood salt and mineral levels (including sodium, potassium, phosphorus, magnesium, and calcium) are within normal limits, or can be corrected to normal with supplements before joining the trial.
- People whose heart electrical activity, measured by a standard heart tracing (ECG), shows a QT interval and resting heart rate within the required ranges (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose breast cancer has spread to distant parts of the body beyond nearby lymph nodes.
- People who have not yet recovered from significant side effects of previous chemotherapy, radiotherapy, or surgery (excluding hair loss and absence of periods).
- People who have or have had another invasive cancer, where treatment for that cancer was completed less than 2 years before signing the consent form; people with non-invasive (in situ) cancers who have completed adequate treatment may still be considered.
- People who have had a bone fracture or surgery involving the knees or hands in the 6 months before joining, or who have a known rheumatological (joint) disease.
- People who have taken opioid painkillers, anti-inflammatory medicines (NSAIDs), topical pain relievers, or corticosteroids (taken by mouth, injection into a joint, or into a muscle) for joint pain or stiffness in the 28 days before registering.
- People with an active hepatitis B or hepatitis C infection.
- People with moderate or severe liver impairment as rated by a standard medical classification (Child-Pugh B or C).
- People with significant stomach or bowel conditions that could affect how the trial medicines are absorbed, such as uncontrolled ulcerative disease, persistent nausea, vomiting or diarrhoea, malabsorption conditions, or previous removal of part of the small bowel.
- People with any other serious uncontrolled medical condition that, in the doctor's judgement, would pose unacceptable risks or interfere with participation, or where life expectancy is estimated to be 5 years or less.
- People who have taken part in another interventional clinical trial and received an experimental treatment within 30 days before joining, or within 5 half-lives of that experimental treatment, whichever is longer.
- People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial.
- People who are under legal guardianship, detained, under court protection, or otherwise unable to give their own consent.
- People who have a known allergy or sensitivity to cannabidiol (CBD) or any ingredient in the CBD product used in this trial.
- People who have previously had a serious reaction to any cannabis-based product, such as cannabis-related psychosis, a panic attack, or delirium.
- People who have used recreational or medicinal cannabis, or synthetic cannabinoid medicines (including Sativex®), within 2 weeks before starting the trial.
- People who have a current or previous psychological, psychiatric, or nervous system condition, including epilepsy, schizophrenia or other psychosis, severe borderline personality disorder, or significant thoughts of suicide.
- People who are currently taking clobazam, valproate, or levodopa.
- People who have a history of substance abuse or dependence involving alcohol, opioids, amphetamines, benzodiazepines, or other illicit stimulants.
- People with significant uncontrolled heart disease or abnormal heart rhythm, including: a heart attack, angina, inflamed heart lining, or heart bypass surgery in the 6 months before the trial; a diagnosed disease of the heart muscle; a previous finding of reduced heart pumping function (below 50%) that had not recovered before the trial; a condition causing an abnormally long QT interval on a heart tracing, or a family history of this or of sudden unexplained death; risk factors for a dangerous heart rhythm called Torsades de Pointes (such as low potassium or magnesium that cannot be corrected, a history of heart failure, or significant slow heart rate); current use of medicines known to affect the QT interval that cannot be safely stopped or swapped; inability to measure the QT interval; or other significant heart rhythm problems such as ventricular tachycardia, complete left bundle branch block, or high-grade heart conduction block.
- People with uncontrolled high blood pressure where the top (systolic) reading is above 160 mmHg.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +33 1 42 11 42 93
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
Not Yet Recruiting
Phase
Phase 3
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 May 2027
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Brief Pain Inventory - Short Form (BPI-SF) Interference score.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.