Early Phase 1 Breast Cancer Trial, Recruiting NCT06435351 Sponsor: H. Lee Moffitt Cancer Center and Research Institute Condition: Breast Cancer
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Early Phase 1 Breast Cancer Trial, Recruiting

NCT06435351
Recruiting Early Phase 1

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 have been diagnosed with stage II or III breast cancer that is largely hormone receptor-negative (ER/PR 10% or less) and HER2-negative, received standard chemotherapy before surgery, had the tumor removed, and still had a significant amount of cancer remaining after treatment.
  • There is enough remaining tumor tissue (from the breast or nearby lymph nodes) available for the research team to analyze genetically.
  • You are 18 years of age or older.
  • You are generally able to carry out daily activities with little to no limitation (confirm with trial site regarding specific fitness assessment).
  • Your heart, liver, kidneys, and blood counts are functioning well enough to participate (confirm with trial site for specific requirements).
  • You have had, or currently have, another type of cancer that is not expected to interfere with this study's treatment or results.
  • You have no signs of cancer that has spread to other parts of the body, and you are within 18 months of finishing your last round of chemotherapy or radiation aimed at curing the cancer.
  • If you are able to become pregnant, you must agree to use reliable birth control throughout the study, and must inform your doctor immediately if you become pregnant.
  • You are willing and able to read and sign a consent form agreeing to take part in the study.

Who may not be able to join:

  • You currently have advanced cancer that cannot be surgically removed, or cancer that has spread to other parts of the body.
  • You have a serious uncontrolled illness or an autoimmune condition that requires strong medications to suppress your immune system.
  • You have a health condition that would make a procedure to collect blood cells (called pheresis) unsafe for you (confirm with trial site).
  • You are currently taking part in another clinical trial involving an experimental treatment.
  • You have a mental health condition or personal circumstances that would make it difficult to follow the study's requirements.
  • You are currently pregnant.

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 June 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
12 June 2024
Est. completion
1 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of patients enrolled who successfully undergo at least one vaccination.

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.

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