Early Phase 1 Breast Cancer Trial, Recruiting NCT07340424 Sponsor: Xiaorong Sun Condition: Breast Cancer
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Early Phase 1 Breast Cancer Trial, Recruiting

NCT07340424
Recruiting Early Phase 1

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 willing to take part voluntarily and sign a consent form
  • Women aged 18 or older
  • Women who have been diagnosed with triple-negative breast cancer through laboratory testing of tissue samples (a specific type of breast cancer where three particular markers — estrogen receptor, progesterone receptor, and HER2 — are found to be negative or very low)
  • Women whose triple-negative breast cancer has spread to other parts of the body (metastatic) and who have already received at least 2 rounds of systemic treatment, with at least 1 of those treatments being for metastatic disease
  • People who have at least one tumour that can be measured on a scan, assessed using standard criteria called RECIST 1.1
  • People whose general health and ability to carry out daily activities falls within a certain range on a standard scale used by doctors (ECOG score of 0 or 1, meaning fully active or able to carry out light work)
  • People whose side effects from previous treatments have mostly resolved to a low level (confirm with trial site for exact grading details), except for hair loss
  • Women who could potentially become pregnant must have a negative pregnancy test within 7 days before starting the trial and must agree to use effective contraception during the trial and for 6 months after the last dose

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 received radiotherapy (other than palliative radiotherapy), chemotherapy, or immunotherapy within 3 weeks before starting the trial (bone-strengthening medications for bone spread may still be allowed — confirm with trial site)
  • People who have received a type of radiation treatment delivered through injection (radionuclide therapy, such as certain radioactive substances) within the 6 months before joining
  • People who are currently receiving chemotherapy, immunotherapy, biological therapy, experimental radionuclide therapy, or any other experimental treatment
  • People who have had major surgery within 28 days before joining the trial
  • People whose doctor estimates their life expectancy to be less than 3 months
  • People whose bone scan shows a specific pattern of widespread bone involvement across the entire skeleton (confirm with trial site for exact definition)
  • People with symptoms of spinal cord compression, or scan findings suggesting it may be about to occur
  • People with brain or central nervous system spread of cancer that is not under control and requires certain medications (such as steroids) to manage symptoms
  • People with a history of another cancer, unless that cancer was fully treated more than 3 years ago with no signs of return, or was a fully treated non-melanoma skin cancer or superficial bladder cancer
  • People with any other condition that the investigating doctor believes could interfere with the trial assessments, treatments, or procedures

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 30 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

  • Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
  • Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
  • Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
  • Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
  • Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Phone: 0531-67626287

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
Early Phase 1
Sponsor
Xiaorong Sun
Registry
ClinicalTrials.gov
Start date
22 May 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The incidence and severity grades of adverse events (AE), serious adverse events (SAE), and unexpected serious adverse reactions (SUSAR) were evaluated according to the CTCAE 5.0 standard.

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: 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.

View original record on ClinicalTrials.gov