Phase 2 Breast Cancer Trial, Recruiting NCT05528133 Sponsor: H. Lee Moffitt Cancer Center and Research Institute Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05528133
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:

  • People who have had breast-conserving surgery (a lumpectomy) along with a procedure to check the lymph nodes under the arm (either a sentinel node biopsy or a full lymph node removal)
  • People whose breast cancer has been confirmed as "Triple Negative" through a tissue sample (meaning the cancer tests negative for certain proteins that drive some breast cancers)
  • People whose tissue sample provides enough material for a specific type of analysis called RSI (confirm with trial site)
  • People whose cancer does not show overexpression of a protein called HER2, as determined by standard laboratory testing guidelines
  • People whose cancer has very low or no presence of hormone receptors (estrogen and progesterone), meaning less than 10% of cancer cells show these receptors on testing
  • People with a life expectancy of more than 16 weeks
  • People with a general health and functioning score (called KPS) of 70 or above (confirm with trial site)
  • People aged 18 years or older
  • People who had surgery within the past 14 days must have fully recovered and received clearance from their surgeon before joining
  • People who have received prior systemic treatments (such as chemotherapy) are still eligible — there is no limit on previous treatments
  • People of childbearing potential, and sexually active males, who commit to using effective contraception for the duration of the study
  • People who are able to give informed consent, either personally or through a family member or healthcare representative, before enrolling in the study

Who may not be able to join:

  • People who have had major surgery or a serious injury and have not yet fully recovered, within 14 days before the study begins
  • People who are pregnant or currently breastfeeding
  • People whose surgery results showed cancer cells at the edges of the removed tissue (known as positive surgical margins)
  • People with a known allergy or sensitivity to any of the medications or ingredients used in the study
  • People whose breast cancer has spread to other parts of the body (metastatic breast cancer)

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 12 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.

Contact this trial

Principal Investigator: Kamran Ahmed, MD, Moffitt Cancer Center

Phone: 813-745-0393

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 January 2023
Est. completion
1 May 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Local Control

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: 12 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