Printed from Voxsanity (voxsanity.com.au) — NCT07151586 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07151586
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
- A person must have signed a written consent form before any trial-related procedures take place (if someone is physically unable to sign, a witness of their choice can sign on their behalf).
- Adults aged 18 years or older.
- A person must have a confirmed diagnosis of breast cancer that has spread to other parts of the body or cannot be surgically removed, and which is classified as "triple-negative" and "HER2-low" based on laboratory testing of the tumour.
- The tumour must show low levels of a protein called HER2, based on specific lab test results (IHC 2+ with a negative ISH test, or IHC 1+), from either the original tumour or a secondary site.
- The tumour must show less than 10% expression of both estrogen receptor (ER) and progesterone receptor (PR) (if a person has cancer in both breasts, both tumours must meet these criteria).
- A person must be eligible to receive the two study drugs — sacituzumab-govitecan and T-Dxd — based on their approved uses (confirm with trial site).
- A person must have a general health and activity level rated at 0 or 1 on a standard medical scale, meaning they are fully active or have only minor restrictions on physical activity.
- Women who could become pregnant and male participants must agree to use appropriate contraception throughout the trial and for up to 7 months after finishing treatment (for women) or up to 4 months (for men).
- A woman is considered able to become pregnant if she is not postmenopausal and has not had a hysterectomy; postmenopausal is defined as being aged 60 or over, or under 60 with at least 12 consecutive months without a period for no reason other than menopause, or having had both ovaries surgically removed.
- Blood and organ function test results from within the past 28 days must meet all of the following standards: haemoglobin (red blood cell level) of at least 9 g/dL without a blood transfusion in the week before testing; white blood cell count (specifically neutrophils) of at least 1,500/mm³ without a growth-stimulating injection in the week before testing; platelet count of at least 100,000/mm³ without a platelet transfusion in the week before registration.
- Liver function test results must be within acceptable ranges — specific limits apply depending on whether liver metastases or a condition called Gilbert's Syndrome are present (confirm with trial site).
- Blood protein (albumin) level must be at least 2.5 g/dL.
- Kidney function, measured by a calculated creatinine clearance, must be at least 30 mL/min.
- Heart function must be adequate, with the heart pumping at least 55% of its capacity, as measured by a heart scan (echocardiogram or similar test).
- Women who could become pregnant must have a negative pregnancy test done within 7 days before being enrolled in the trial.
- A person must be affiliated with the French Social Security System or an equivalent system.
- A person must be willing and able to follow the trial schedule, including attending appointments, receiving treatment, and completing all required check-ups and follow-up visits.
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 who have previously been treated with any antibody-drug conjugate (a type of targeted drug) that was directed at the HER2 or TROP2 proteins.
- People with heart or cardiovascular disease that is not well controlled or is considered significant.
- People with cancer that has spread to the brain, unless those brain metastases have been treated, are causing no symptoms, do not require ongoing steroid medication, and appear stable on a recent brain scan — people who needed treatment for brain metastases may still be considered if at least 14 days have passed since surgery or radiation and their condition is clinically stable without ongoing steroids (confirm with trial site).
- People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, or who currently have or are suspected to have this condition.
- People with any medical history or condition that the treating doctor considers incompatible with taking part in this study.
- People with a known allergy or serious sensitivity to any of the trial drugs or their ingredients.
- People with other medical or psychiatric conditions that, in the treating doctor's opinion, could affect the reliability of study results or prevent them from completing the trial.
- People with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment.
- People who have been enrolled in another treatment trial within the 30 days before joining this trial.
- Women who are pregnant or breastfeeding at the time of enrolment, or who intend to become pregnant during the study or within 7 months after treatment ends.
- People who are deprived of their liberty or are under protective custody or legal guardianship.
- People who are unwilling or unable to attend the required medical follow-up visits due to geographic, family, social, or psychological reasons.
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.
Contact this trial
Principal Investigator: Alexandre TASSIN DE NONNEVILLE, Institut Paoli-Calmettes
Phone: +337714415 82
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 2
Sponsor
UNICANCER
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
1 October 2029
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Overall survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.