Phase 3 Breast Cancer Trial, Recruiting NCT05232916 Sponsor: Greenwich LifeSciences, Inc. Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05232916
Recruiting Phase 3

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 a specific genetic marker called HLA-A*02 (a blood type marker), unless you are being enrolled in a special arm of the trial that does not require this marker
  • Your breast cancer has been confirmed by a tissue sample (biopsy) to be HER2-positive (a type of breast cancer that tests positive for a specific protein)
  • You have completed both pre-surgery (neoadjuvant) and post-surgery (adjuvant) standard treatment that included the drug trastuzumab
  • You were diagnosed at Stage I, II, or III and either had some cancer remaining after pre-surgery treatment, OR were diagnosed at Stage III and had no cancer remaining after pre-surgery treatment
  • You are able to start the trial treatment within one year of finishing your trastuzumab-based therapy and other standard treatments (hormone therapy can continue during the trial)
  • Your doctor has determined there is no current sign of breast cancer remaining or returning
  • You are generally well enough to carry out daily activities (confirm with trial site)
  • Your organs (such as kidneys and liver) are functioning well enough (confirm with trial site)
  • You have tested negative for pregnancy, or you have been confirmed as post-menopausal
  • If you could become pregnant, you are willing to use a highly effective form of birth control
  • You must both live in and have received your cancer treatment in the same country where the trial site is located

Who may not be able to join:

  • You have been diagnosed with Stage IV (advanced/spread) or metastatic breast cancer at any point
  • You have or had inflammatory breast cancer (a specific type of aggressive breast cancer)
  • You are currently taking part in another clinical trial involving an experimental treatment
  • You are currently receiving chemotherapy
  • You need long-term use of steroid medications or other drugs that suppress the immune system
  • You have a history of immune system deficiency or a currently active autoimmune disease
  • You have had a serious allergic reaction (including anaphylaxis/severe allergic shock) to certain immune-stimulating drugs or yeast-based products used in the trial medication (confirm with trial site)
  • You have or have had another type of cancer, except for certain treated skin cancers or a specific treated type of cervical cancer
  • You currently have an active infection
  • You have HIV with a detectable level of virus in your blood within the last 6 months (note: people with HIV who are on effective treatment and have an undetectable virus level within the last 6 months may still be eligible)

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 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.
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 3
Sponsor
Greenwich LifeSciences, Inc.
Registry
ClinicalTrials.gov
Start date
11 August 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Invasive Breast Cancer-free Survival (IBCFS)

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