Breast Cancer Trial, Recruiting NCT05505643 Sponsor: Washington University School of Medicine Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05505643
Recruiting Not Applicable

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 diagnosed with a specific type of breast cancer called invasive ductal carcinoma that is estrogen receptor positive and HER-2 negative, is a lower grade (grade 1 or 2), has a limited amount of a related pre-cancer component (less than 25%), and measures 2 cm or smaller with no spread to lymph nodes or other parts of the body.
  • If a pre-cancerous area called DCIS is found in the biopsy, it must make up less than 25% of the tumor and must be directly connected to the main cancer, not appearing as a separate area.
  • For certain tumour sizes and scores, a genetic test called an Oncotype DX test will be done, and the result must be below 26 to be eligible for those cases (confirm with trial site for details on which tumours require this).
  • People aged 50 or older.
  • People whose lymph nodes under the arm on the same side as the cancer have been assessed and found to be cancer-free, through one of three methods: an ultrasound scan, a sentinel lymph node biopsy, or a needle biopsy of a lymph node, with no other concerns about spread to lymph nodes.
  • People who are able to understand and are willing to sign a formal consent document approved by an ethics review board.

Who may not be able to join:

  • People for whom chemotherapy before surgery has been recommended.
  • People with a previous history of breast cancer.
  • People who have had breast implants or augmentation.
  • People with a known allergy to local anaesthetics.
  • People who are pregnant or breastfeeding; women who could potentially become pregnant must have a negative pregnancy test within 14 days of entering the study.
  • People whose cancer has grown into the skin or the chest wall.

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 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Heather Garrett, M.D., Washington University School of Medicine

Phone: 636-916-9662

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
3 April 2024
Est. completion
30 April 2033

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety Lead-In: Number of treatment-related complications; Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.

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: 26 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