Printed from Voxsanity (voxsanity.com.au) — NCT06664892 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Breast Cancer Trial, Not Yet Recruiting
NCT06664892
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
- People aged 60 or older who have invasive breast cancer (of a certain size range) with no cancer spread to the lymph nodes under the arm, who had breast-conserving surgery (such as a lumpectomy), received a high-risk result on a Mammaprint or Oncotype tumour gene test, and are receiving chemotherapy. (If no lymph node surgery was planned, a pre-surgery ultrasound of the underarm must have shown no signs of cancer.)
- People whose breast cancer is of an invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular type.
- People with any hormone receptor or HER2 status (ER, PR, or HER2-positive or negative).
- People whose surgery removed the cancer with clear margins — meaning no cancer cells were found within 2mm of the surgical edge — or who had a second surgery that achieved clear margins.
- People with cancer in both breasts may be eligible, as long as each cancer separately meets the trial's entry criteria.
- People whose treatment plan does not include radiation to the lymph nodes.
- People with no signs or concerns of cancer having spread to other parts of the body.
- People receiving chemotherapy either before or after surgery, where the cancer's stage before treatment meets the trial's entry requirements — the specific chemotherapy used is decided by the treating cancer doctor, and no systemic therapies are excluded from this trial.
- People who are considered well enough to receive the planned cancer drug treatments.
- People receiving immunotherapy.
- People receiving HER2-targeted therapy, including at the same time as radiation.
- People receiving other targeted therapies, including CDK inhibitors and similar drugs.
- People receiving hormone (endocrine) therapy, including at the same time as radiation.
- People who are also participating in another clinical trial that does not involve radiation therapy.
- People who are able to read and sign an informed 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 with stage IV (advanced/metastatic) breast cancer.
- People whose surgical margins could not be checked under a microscope, or where cancer cells were found at the surgical edge — unless a follow-up surgery successfully cleared the margins.
- People who have previously had radiation therapy to the chest or breast.
- People whose radiation treatment plan includes any of the following methods: brachytherapy (internal radiation) or radiation given during surgery (IORT), proton therapy, radiation to the lymph node regions, or a targeted boost of radiation to the tumour bed.
- People who have had breast reconstruction using an implant or tissue expander.
- People who had a mastectomy (full breast removal) for the current breast cancer.
- People whose treatment plan requires a radiation boost to the tumour site.
- People with lymph nodes in the underarm or on the opposite side that can be felt or appear suspicious on imaging, or who have more advanced lymph node involvement (N2 disease).
- People with Paget's disease of the nipple.
- People with non-epithelial breast cancers, such as sarcoma or lymphoma of the breast.
- People who have had a non-breast cancer within the past 5 years — except for certain early-stage cancers treated only with local removal, or basal cell and squamous cell skin cancers.
- People with active connective tissue disease, specifically dermatomyositis with abnormal muscle enzyme levels or an active skin rash, systemic lupus erythematosus, or scleroderma.
- People who are pregnant or breastfeeding at the time of enrolment, or who plan to become pregnant during treatment.
- People with serious medical or psychiatric conditions that could interfere with taking part in the trial.
- People with an active infection in the area of the body where radiation would be delivered.
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.
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: Suzanne Russo, MD, MetroHealth Medical Center
Phone: 216-778-5470
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
Not Applicable
Sponsor
MetroHealth Medical Center
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
31 December 2027
Primary endpoints
Primary(1); Primary (2)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.