Phase 2 Breast Cancer Trial, Recruiting NCT04892693 Sponsor: Seoul National University Hospital Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT04892693
Recruiting Phase 2

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

  • Adults aged 19 years or older.
  • People who have been diagnosed with breast cancer that cannot be surgically removed or has spread to other parts of the body, confirmed by pathology testing.
  • People whose tumour has a specific genetic or biological feature called homologous recombination deficiency (HRD), which can be identified through a BRCA1 or BRCA2 gene mutation (inherited or acquired), mutations in certain other DNA repair genes (including ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L), or through a specialised laboratory test called a RAD51 foci formation assay (confirm with trial site).
  • People who have previously been treated with a chemotherapy drug called a taxane, unless that treatment was medically unsuitable for them.
  • People who have previously received platinum-based chemotherapy are eligible, provided the cancer did not progress while they were on that treatment, or — if the platinum was given before the cancer spread — that at least 6 months passed between the last dose and the cancer returning.
  • People whose cancer has been confirmed by imaging (such as a CT or MRI scan) to have progressed during or after their most recent treatment, or within 6 months of finishing earlier preventive chemotherapy.
  • People for whom at least 3 weeks have passed since their last chemotherapy treatment.
  • People for whom at least 2 weeks have passed since their last hormone therapy or radiation therapy (including palliative radiation).
  • People with a general health and activity level rated as ECOG 0 (fully active) or 1 (restricted in physically demanding activity but able to do light work) (confirm with trial site).
  • People who have at least one area of disease that can be clearly measured by CT scan (or MRI if CT is not possible) at the start of the trial and monitored over time.
  • People who are capable of becoming pregnant or fathering a child and who agree to use a highly effective form of contraception — such as a copper intrauterine device — during the trial and for at least 7 months after the last dose of the study treatment.
  • People with blood and organ function within acceptable ranges, tested within 28 days before starting treatment, including sufficient red blood cells, white blood cells, and platelets, as well as adequate liver and kidney function (confirm specific values with trial site).
  • People who are premenopausal and have a negative urine pregnancy test within 7 days before joining the trial.
  • People who are able to understand what is involved in the trial and are willing and able to follow all study requirements.
  • People who have provided written informed consent before entering 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 previously been treated with a type of drug called a PARP inhibitor, unless they took part in a clinical trial testing a PARP inhibitor as a preventive (adjuvant) treatment and their cancer returned at least 6 months after completing that treatment.
  • People who have received more than three lines of systemic chemotherapy for advanced or metastatic disease (note: preventive chemotherapy given before or after surgery, and hormone therapy, are not counted toward this limit).
  • People for whom a standard approved treatment for metastatic breast cancer is available.
  • People who have had another separate cancer in the past, with some exceptions — including cancers treated with curative intent where there has been no known active disease for at least 3 years, cancer in the other breast, adequately treated non-melanoma skin cancers, or adequately treated non-invasive (in situ) cancers with no current evidence of disease.
  • People with conditions affecting their digestive system that would prevent them from taking oral medication or absorbing it properly, such as Crohn's disease, ulcerative colitis, or certain previous bowel surgeries.
  • People who have a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
  • People with brain metastases that are causing symptoms and are not well controlled, or people with spinal cord compression that has not been definitively treated and has not been clinically stable for at least 28 days (confirm specific circumstances with trial site).
  • People with an active infection, a weakened immune system, active tuberculosis, active hepatitis B (note: people who are simply carriers of hepatitis B or have a resolved past infection may still be eligible — confirm with trial site), active hepatitis C (note: people with hepatitis C antibodies may be eligible if a specific RNA test is negative — confirm with trial site), or HIV.
  • People with a known serious allergic or hypersensitivity reaction to any of the drugs used in this study or their ingredients.
  • People who are pregnant or breastfeeding.
  • People whom the trial investigator considers unsuitable to participate or unlikely to follow the study requirements.

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 31 July 2026

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

Principal Investigator: Seock-Ah Im, MD, PhD, Seoul National University Hospital

Phone: 82-2-2072-0850

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
Phase 2
Registry
ClinicalTrials.gov
Start date
25 May 2021
Est. completion
31 May 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Response rate (RR)

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: 31 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