Printed from Voxsanity (voxsanity.com.au) — NCT07047443 — 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
NCT07047443
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
- Women between the ages of 18 and 75 (including those exact ages).
- People with breast cancer that cannot be surgically removed or has spread to other parts of the body, where the cancer has been confirmed by laboratory testing to have high, low, or very low levels of a protein called HER2.
- People whose cancer has stopped responding to standard treatments at the advanced stage.
- For people with high HER2 levels: those who may have received an older type of targeted drug delivery treatment (called a second-generation ADC, such as T-DM1), but have not received a newer type (called a third-generation ADC, such as T-DXd). For people with low or very low HER2 levels: those who have not received any ADC drug treatment.
- For high HER2 breast cancer: people who have received at least one anti-HER2 treatment at the advanced stage. For hormone-sensitive breast cancer with low or very low HER2: people whose cancer has stopped responding to a type of treatment called CDK4/6 inhibitors at the advanced stage. For hormone-insensitive breast cancer with low or very low HER2: people who have received at least one chemotherapy treatment at the advanced stage.
- People who are generally well enough to carry out light activity, as measured by a standard health scale called the ECOG score of 0 or 1 (confirm with trial site).
- People who have at least one area of cancer that can be tracked or measured using standard imaging guidelines.
- People with organs (such as kidneys, liver, and heart) that are working well enough to meet the trial's requirements (confirm with trial site).
- People who are able to have children, or whose partners are able to have children, and who agree to use reliable contraception from the first dose until 120 days after the last dose of the trial treatment.
- People who choose to participate voluntarily and sign a consent form agreeing to take part in the study.
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 had another type of cancer in the past 5 years, except for certain cured skin cancers (basal cell carcinoma) or a type of pre-cancer of the cervix (carcinoma in situ).
- People who have a build-up of fluid in body cavities (such as the abdomen, lungs, or around the heart) that cannot be controlled by draining.
- People who have had major cancer surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, biological therapy, or other cancer drugs within 4 weeks before the first dose; or hormone therapy within 2 weeks before the first dose.
- People with high HER2 breast cancer who have already received a newer type of targeted drug delivery treatment (third-generation ADC, such as T-DXd); or people with low or very low HER2 breast cancer who have received any ADC drug treatment.
- People with certain active or recurring autoimmune conditions (where the immune system attacks the body), such as autoimmune hepatitis, eye inflammation, bowel inflammation, or kidney inflammation — some milder conditions may still be eligible (confirm with trial site). People with asthma that currently requires medication to open the airways may not be eligible.
- People with a history of immune system deficiency, a positive HIV test, other immune disorders present from birth or acquired over time, or a history of having received an organ transplant.
- People with serious heart conditions, such as unstable chest pain, significant heart failure, certain heart rhythm problems requiring treatment, or a heart attack in the 6 months before joining the trial.
- People with known or suspected lung inflammation (interstitial pneumonia), or other moderate to severe lung conditions that could affect the safety of the trial treatment, including conditions such as pulmonary fibrosis, pulmonary embolism, severe asthma, severe COPD, or autoimmune conditions affecting the lungs. People who had a severe (grade 3 or higher) lung inflammation reaction during previous immunotherapy are also not eligible.
- People with a known inherited or acquired tendency to bleed excessively (such as haemophilia or clotting disorders).
- People with active hepatitis B or hepatitis C infections meeting certain laboratory thresholds, liver cirrhosis, or serious infections currently requiring antibiotic, antiviral, or antifungal treatment.
- People who still have significant side effects (above a certain severity level) from previous cancer treatments that have not yet resolved, with the exception of hair loss and some specific long-term mild side effects assessed case by case (confirm with trial site).
- People with a known allergy to the trial drug or any of its ingredients.
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
Phone: +86 13802214658
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
Anhui Provincial Cancer Hospital
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
31 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Maximum Tolerated Dose (MTD)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 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.