Phase 3 Breast Cancer Trial, Recruiting NCT06507618 Sponsor: University of Virginia Condition: Breast Cancer
Back to Breast Cancer

Phase 3 Breast Cancer Trial, Recruiting

NCT06507618
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:

  • People who have been diagnosed with a specific type of invasive breast cancer that is hormone receptor positive (ER+, PR+/-) and HER2 negative, with no cancer spread to the lymph nodes
  • People who are generally well enough to carry out daily activities, based on a standard fitness scale (scores 0–2)
  • Women aged 65 years or older
  • People whose cancer has been assessed as suitable for breast-conserving surgery (surgery that removes the tumour but keeps most of the breast) and who have chosen to have this type of surgery
  • People who are considered suitable for radiation therapy
  • People who are considered suitable for hormone-blocking therapy, either tamoxifen or an aromatase inhibitor
  • People who are able to swallow tablets and are willing to take hormone-blocking therapy for the 3 months before surgery
  • People who are willing to follow certain lifestyle guidelines throughout the study (details available from the trial site)
  • People who are willing to sign and date a consent form
  • People who are willing to follow all study procedures and are available for the full duration of the study

Who may not be able to join:

  • People who have breast cancer in both breasts at the same time
  • People whose cancer appears in more than one separate area of the same breast
  • People who have previously taken tamoxifen or aromatase inhibitors
  • People who have previously had radiation therapy to the same breast being treated
  • People who have another cancer that is currently getting worse or requires active chemotherapy or radiation treatment (note: stable, low-risk cancers may be considered on a case-by-case basis — confirm with trial site)
  • People who are currently taking or planning to take certain medications that interact with a specific liver enzyme (CYP2D6), such as fluvoxamine or paroxetine, and for whom an alternative hormone-blocking therapy that does not rely on that pathway is not suitable

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 13 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.

Contact this trial

Principal Investigator: Shayna L Showalter, MD, University of Virginia

Phone: 434-243-8101

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 3
Registry
ClinicalTrials.gov
Start date
19 July 2024
Est. completion
30 June 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET); Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET

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: 13 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