Phase 2 Breast Cancer Trial, Recruiting NCT06185205 Sponsor: Virginia Commonwealth University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06185205
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 are female and have been newly diagnosed with ductal carcinoma in situ (DCIS) and/or invasive breast cancer, confirmed by a tissue sample analysis.
  • People who were between 45 and 79 years old at the time of diagnosis.
  • People who have already had a lumpectomy (surgery to remove the tumour while keeping the breast) where the edges of the removed tissue were found to be clear of cancer cells.
  • People whose tumour is classified as an early stage (Tis, T1, or T2), and if T2, the tumour must be no larger than 3 cm across.
  • People whose cancer tests positive for HER2 (a specific protein), where the treating doctor has prescribed HER2-targeted treatment as part of their care.
  • People with invasive breast cancer who have had a procedure to check the lymph nodes under the arm, with results confirming no cancer was found in those nodes (with some exceptions — confirm with trial site).
  • People aged 70 or older with a specific tumour profile (ER+, PR+, HER2-negative, low-to-intermediate grade, tumour 2 cm or smaller) may not be required to have the lymph node procedure, provided they agree to follow recommendations about a type of hormone-blocking medication called an aromatase inhibitor (confirm with trial site).
  • People who are able to understand the study information and are willing to sign a written consent form in English.

Who may not be able to join:

  • People who are currently pregnant or breastfeeding.
  • People who have an active collagen-vascular disease (a group of conditions affecting connective tissue, such as lupus or scleroderma).
  • People who have Paget's disease of the breast (a rare form of breast cancer affecting the nipple area).
  • People who have a previous history of DCIS or invasive breast cancer before their current diagnosis.
  • People who have previously received radiation therapy to the breast or chest area for any reason.
  • People whose cancer is found in more than one separate area of the breast (multicentric carcinoma).
  • People who have breast cancer in both breasts at the same time.
  • People whose surgical margins (edges of the removed tissue) cannot be assessed under a microscope, or where cancer cells were found at the margins.
  • People where the surgical cavity (the area left after the tumour was removed) cannot be clearly identified by the treating doctor.
  • People whose treatment planning does not meet the specific radiation dose requirements set out in the study guidelines (confirm with trial site).
  • People who, in the opinion of the treating doctor, have a medical, psychological, or social condition that could increase risk or make it difficult to follow the study requirements.

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 14 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: Bridget Quinn, MD, Ph.D, Virginia Commonwealth University

Phone: 804-628-6430

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
12 December 2023
Est. completion
31 January 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course

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: 14 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