Phase 2 Breast Cancer Trial, Recruiting NCT06129747 Sponsor: Case Comprehensive Cancer Center Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06129747
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 whose breast cancer has come back, where the returned cancer has been confirmed by a tissue sample (biopsy) as one of several specific types, including ductal carcinoma in-situ (DCIS) or certain types of invasive breast cancer, and where at least 3 years have passed since the end of their last course of whole-breast radiation treatment.
  • People whose returned cancer (lesion) measures less than 3 cm and was treated with surgery that removed only part of the breast (partial mastectomy).
  • People whose surgical margins are clear, meaning no cancer cells were found at the edges of the removed tissue, or who had a successful repeat surgery to achieve clear margins.
  • People with invasive (spreading) cancer whose scans — either a CT scan of the chest and abdomen plus a bone scan, or a PET scan — show no signs the cancer has spread elsewhere in the body.
  • People who are receiving or planning to receive hormone therapy or chemotherapy alongside the trial treatment, provided chemotherapy is given at least 2 weeks apart from radiation (HER2-targeted therapy may be given at the same time as radiation).
  • People aged 18 or older.
  • People who are able to understand the study information and are willing to sign a consent form.
  • People who are reasonably well and able to carry out daily activities, based on a standard health performance scale (ECOG score of 2 or below).
  • People who, in their doctor's assessment, have a life expectancy of at least 12 months.
  • People of any gender identity, as this trial is open to all genders.

Who may not be able to join:

  • People whose cancer has spread to lymph nodes or other parts of the body, and who are fewer than 3 years out from their previous radiation treatment.
  • People whose cancer is a specific type called pure invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive DCIS spanning more than 3 cm, or a rare non-epithelial breast cancer such as lymphoma or sarcoma.
  • People who have cancer in more than one area of the breast (multicentric carcinoma), or who have suspicious lymph nodes in certain areas that have not been confirmed as cancer-free by biopsy or cell testing.
  • People with Paget's disease of the nipple (a rare form of breast cancer affecting the nipple area).
  • People whose cancer involves the skin of the breast.
  • People who have a connective tissue condition called scleroderma or dermatomyositis.
  • People with psychiatric, neurological, or addiction-related conditions that would make it difficult to understand and provide informed consent.
  • People who are pregnant or currently breastfeeding, due to the potential risks of radiation exposure.
  • People who have a known BRCA1 or BRCA2 gene mutation.

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 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: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Phone: (216) 844-2514

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
30 November 2023
Est. completion
9 August 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment-related adverse events as graded by CTCAE criteria

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