Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT07654257 Sponsor: Virginia Commonwealth University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT07654257
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • The person must be female.
  • They must have been recently diagnosed with a type of breast cancer called Ductal Carcinoma in Situ (DCIS) and/or invasive breast cancer, confirmed by a tissue sample analysis.
  • They must be between 40 and 85 years old at the time of diagnosis.
  • They must have already had a lumpectomy (surgery to remove the tumour) where the tissue around the removed tumour was found to be clear of cancer cells.
  • The tumour must be classified as a certain early stage (called Tis, T1, or T2).
  • If the tumour is T2 stage, it must be no larger than 3 cm at its widest point.
  • If the breast cancer tests positive for a protein called HER2, the treating doctor must be planning to give, or must have already given, a treatment that targets HER2.
  • For people with invasive breast cancer, a procedure to check the lymph nodes under the arm must have been carried out, and those lymph nodes must have tested negative for cancer — with some exceptions noted below (confirm with trial site).
  • People aged 70 or older with certain hormone-receptor-positive, HER2-negative, low-to-moderate grade tumours of 2 cm or smaller may not be required to have the lymph node check (confirm with trial site).
  • For people aged 50–69 with certain low-to-moderate grade, hormone-receptor-positive, HER2-negative tumours of 2 cm or smaller and no signs of cancer in the armpit on imaging, the decision about whether the lymph node procedure is needed may be left to the surgeon (confirm with trial site).
  • The person must agree to follow recommendations regarding a type of hormone-blocking medication called an aromatase inhibitor.
  • Treatment with a specific internal radiation technique (brachytherapy) must be able to begin within 12 weeks of the lumpectomy, any follow-up margin surgery, or the end of chemotherapy.
  • The person must be able to understand and be willing to sign a written consent form.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are pregnant or breastfeeding.
  • People with an active disease affecting the body's connective tissues (called collagen-vascular disease).
  • People with a condition called Paget's disease of the breast.
  • People who have previously been diagnosed with DCIS or invasive breast cancer at any time before the current diagnosis.
  • People who have previously had 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 (called multicentric carcinoma).
  • People who have breast cancer in both breasts at the same time.
  • People whose surgical margins could not be properly assessed under a microscope, or where cancer cells were found at the edges of the removed tissue.
  • People who received chemotherapy before surgery (called neoadjuvant chemotherapy).
  • People where the surgical cavity left after the lumpectomy cannot be clearly identified or is not suitable for the radiation implant procedure, as determined by the treating doctor.
  • People who have a medical, psychological, or social condition that, in the opinion of the treating doctor, 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 20 July 2026

Contact this trial

Principal Investigator: Bridget Quinn, MD, 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
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2026
Est. completion
30 September 2036

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205)

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: 20 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