Phase 2 Breast Cancer Trial, Recruiting NCT05472792 Sponsor: UNC Lineberger Comprehensive Cancer Center Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05472792
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 willing and able to sign a consent form agreeing to take part in the study and allowing their personal health information to be shared.
  • Women aged 65 or older who have been newly diagnosed with invasive breast cancer (not a recurrence).
  • People whose tumor is classified as a small, early-stage tumor (pathological T1 stage — generally 2 cm or smaller).
  • People whose breast cancer tests positive for estrogen and progesterone receptors (meaning the cancer is hormone-sensitive, at 10% or more on lab testing).
  • People whose cancer tests negative for a protein called HER2, based on standard laboratory guidelines.
  • People whose tumor is classified as Grade 1 or Grade 2 (lower-grade, slower-growing cancers).
  • People with no cancer found in nearby lymph nodes, based on clinical assessment or pathology results.
  • People with no signs that cancer has grown into nearby blood vessels or lymph vessels in the breast tissue.
  • People whose surgery left clear margins of at least 2 mm around the tumor (meaning the surgeon removed enough tissue around the cancer).
  • People who have already had breast-conserving surgery (sometimes called a lumpectomy), with or without a lymph node procedure.
  • People whom the treating radiation oncologist considers suitable for a targeted radiation treatment called Accelerated Partial Breast Irradiation (APBI).
  • People who have had or currently have another type of cancer, as long as that cancer and its treatment are unlikely to interfere with this trial (confirm with trial site).
  • People already enrolled in another clinical trial, as long as there is no conflict with this trial's treatments.

Who may not be able to join:

  • People who are receiving or planning to receive chemotherapy before or after surgery during the study period.
  • People currently taking anti-hormonal medications (such as tamoxifen or aromatase inhibitors), unless those medications are stopped within 30 days of being enrolled in the trial.
  • People currently using hormone replacement therapy, unless it is stopped within 30 days of being enrolled in the trial.
  • People whose breast cancer appears in more than one area of the same breast.
  • People who have had tissue rearrangement procedures inside the area where the tumor was removed.
  • People who have been diagnosed with breast cancer in both breasts at the same time.
  • People with any signs that the cancer has spread to other parts of the body, based on physical examination or imaging.
  • People who have previously had radiation therapy to the breast or chest area.
  • People with autoimmune conditions that could increase the risks associated with radiation treatment (confirm with trial site).
  • People with serious uncontrolled medical conditions that would make hormone therapy or radiation therapy unsuitable for them.

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 21 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: Dana Casey, MD, University of North Carolina, Chapel Hill

Phone: +1 919-966-4432

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
Sponsor
UNC Lineberger Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
17 May 2022
Est. completion
15 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30; Patient reported outcomes assessed by EORTC QLQ-BR45

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: 21 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