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NCT05382286

NCT05382286
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have triple-negative breast cancer (a specific type of breast cancer) that has spread or cannot be removed by surgery, and you have not yet received any systemic (whole-body) treatment for this advanced stage of the disease.
  • If you previously had early-stage breast cancer (Stage I to III) and were treated, at least 6 months must have passed since that treatment ended before your cancer came back.
  • If your cancer was found to have already spread at the time of your first diagnosis (called "de novo" metastatic), you may still be eligible.
  • Your tumor must test positive for a protein called PD-L1, which will be checked using a recent or stored tissue sample.
  • Your cancer must be measurable on a CT scan or MRI.
  • You must be in relatively good general health, able to carry out daily activities with little to no limitation (confirmed by a standard health scale used in cancer trials).
  • Your heart, liver, kidneys, and other organs must be functioning well enough as shown by blood tests.
  • If you are able to have children and are sexually active with a partner of the opposite sex, you must agree to use specific birth control methods as required by the trial.
  • If you have HIV, you must be on HIV medication and your HIV must be well controlled.

Who may not be able to join:

  • You are pregnant (confirmed by a blood test) or currently breastfeeding.
  • You have previously received a type of cancer treatment that targets certain immune system receptors (confirm with trial site).
  • You have received systemic cancer treatment (other than hormone therapy) in the past 6 months, or radiation therapy in the past 2 weeks.
  • You are currently taking part in another clinical trial involving an experimental treatment or device within the past 4 weeks (being in an observation-only study is acceptable).
  • You have previously been treated with a specific class of chemotherapy drugs called topoisomerase 1 inhibitors, or certain targeted drug treatments that contain this type of drug.
  • You currently have another active cancer (in addition to your breast cancer).
  • You currently have a serious active infection that requires antibiotic treatment.
  • You have HIV and also have a history of two specific conditions: Kaposi sarcoma or Multicentric Castleman Disease.
  • You currently have an active hepatitis B or hepatitis C infection.
  • You have an active autoimmune disease (where the immune system attacks the body) that has needed medical treatment in the past 2 years.

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Sponsor
Gilead Sciences
Registry
clinicaltrials_gov
Start date
25 July 2022
Est. completion
1 February 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

12 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov