Phase 2 Brain Cancer Trial, Recruiting NCT05535413 Sponsor: Hunan Cancer Hospital Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT05535413
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • You are between 18 and 70 years old
  • You have been diagnosed with breast cancer that has come back or spread to other parts of the body, and your cancer has tested negative for HER2 (a specific protein)
  • You have at least one measurable area of cancer in the brain that is 10mm or longer
  • You are fairly active and able to care for yourself (your doctor will assess this using a standard scale)
  • You have brain tumors that have either never been treated, or were treated before but are not currently getting worse and do not need urgent treatment right now
  • Any side effects from previous cancer treatments have mostly cleared up before joining the trial
  • Your blood cell counts (white blood cells, platelets, and red blood cells) are within acceptable levels based on a blood test taken within 1 week before joining
  • Your liver and kidney function tests are within acceptable levels taken within 1 week before joining
  • If you are able to have children, you agree to use effective birth control during the study and for 90 days after the last dose, and you have a negative pregnancy test before starting
  • You are expected to live for more than 12 weeks
  • You are able to attend appointments and follow the treatment plan

Who may not be able to join:

  • Your breast cancer has tested positive for HER2 (a specific protein)
  • You have had another type of cancer in the last 5 years, unless it was a certain type of skin cancer or early-stage cervical cancer that has been fully cured
  • You have recently received cancer treatments such as chemotherapy, radiation, hormone therapy, biological therapy, immunotherapy, or certain traditional medicines (confirm with trial site for exact timeframes)
  • You have had major surgery or a serious injury within 4 weeks before starting the trial, or you are planning to have non-emergency surgery during the trial
  • You have significant nerve damage in your hands or feet (Grade 2 or higher), or you previously had serious nervous system side effects from certain cancer drugs
  • You have used a drug called capecitabine within the past 6 months, or it did not work well for you in the past, or you were unable to tolerate it
  • You have brain tumors that need urgent treatment right now, for example because they are in a dangerous location like the brainstem
  • You have cancer that has spread to the thin layers of tissue surrounding the brain and spinal cord
  • You are pregnant or breastfeeding
  • You have other serious health conditions affecting your heart, kidneys, liver, or other organs that could interfere with treatment
  • You are known to be allergic to any of the drugs or ingredients used in this trial
  • You are unable to have a brain MRI scan for any reason
  • The trial doctor does not think it is appropriate for you to participate
  • You are taking or need to take steroid medications (corticosteroids) in certain situations (confirm with trial site)

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 2 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Hunan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
1 January 2023
Est. completion
31 October 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

CNS-Objective Response Rate (ORR)

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: 2 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