Printed from Voxsanity (voxsanity.com.au) — NCT07643584 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07643584
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 who are able to understand the study and are willing to sign a written consent form (remote consent may be allowed based on the reviewing board's policy).
- People who are willing to follow all study procedures and lifestyle requirements for the full length of the study.
- People aged 18 to 80 years (male or female).
- People diagnosed with breast cancer classified as clinical stage T1–3 N2–3 M0 before starting pre-surgery chemotherapy.
- People diagnosed with breast cancer classified as clinical stage T1–3 cN1 before starting pre-surgery chemotherapy, and who were found to have a certain level of lymph node involvement (N2–3) based on the final surgical pathology report.
- People who had an ultrasound of the armpit area, with a needle biopsy of armpit lymph nodes confirming cancer spread there, either before or within 14 days of starting pre-surgery chemotherapy.
- People who had their tumour tested for estrogen receptor, progesterone receptor, and HER2 status on a diagnostic biopsy before starting pre-surgery chemotherapy (confirm with trial site if HER2 result was unclear).
- People who completed their full planned pre-surgery chemotherapy course before having surgery (chemotherapy planned to continue after surgery is not permitted; chemotherapy given after surgery based on final pathology results may be allowed at the treating doctor's discretion).
- People with HER2-positive tumours who received an FDA-approved anti-HER2 therapy (such as trastuzumab, or trastuzumab combined with pertuzumab, or another approved option) as part of their pre-surgery chemotherapy — other regimens may be allowed if given within an approved clinical trial.
- People who have benign breast disease, LCIS, or DCIS in the opposite breast.
- People whose armpit area showed no significant swelling on physical examination at the end of pre-surgery chemotherapy, and whose imaging showed all lymph nodes measuring 1 cm or smaller.
- People with an ECOG (activity level) score of 0 or 1, meaning they are fully active or have only minor restrictions on physically demanding activity.
- People in whom at least one sentinel lymph node (the first lymph node that cancer is likely to spread to) was identified and removed by the surgeon.
- People who had a complete disappearance of cancer in both the breast and armpit lymph nodes (pathologic complete response) may be considered for a discussion about whether radiation therapy could be omitted, through a specialist team review (confirm with trial site).
- People who had breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery completed within 56 days of their last pre-surgery chemotherapy dose, with no cancer cells found at the surgical margins.
- Females who could potentially become pregnant must have a negative blood pregnancy test on the day of surgery before the procedure begins.
- Females who could potentially become pregnant, and males whose partners could potentially become pregnant, who agree not to donate sperm and to use effective contraception or abstinence for the duration of the study and for as long as directed by standard or study chemotherapy and radiation therapy guidelines, whichever period is longer (women approaching menopause must have had no periods for 12 or more months to be considered not of childbearing potential).
- People who are considered medically fit for surgery, defined as having an ECOG score of 0–1 (note: having nicotine in the blood or a high blood sugar marker (A1c) does not prevent eligibility for surgery, though these will be monitored as part of standard care).
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 a diagnosed psychiatric illness, or whose personal or social situation would make it difficult to follow study requirements or to give informed consent.
- People with serious medical conditions — such as an uncontrolled infection (including HIV), uncontrolled diabetes, or heart disease — that the treating doctor believes would make participation unsafe.
- People with inflammatory breast cancer.
- People who have had any other cancer within the past 5 years, with the exception of certain skin cancers (basal cell or squamous cell carcinoma) treated by local removal only, or carcinoma in situ of the cervix.
- People whose HER2 status could not be clearly determined (result was unclear or inconclusive).
- People who received hormone-based (endocrine) therapy for more than 8 weeks before starting pre-surgery chemotherapy.
- People who received radiation therapy before surgery as part of their treatment.
- People who already had sentinel lymph node surgery or a surgical biopsy to check lymph node status before or during pre-surgery chemotherapy.
- People with a prior history of breast cancer (invasive or DCIS) in the same breast being treated (LCIS and benign breast disease in that breast are allowed).
- People who have previously had surgery on the armpit area on the same side as the affected breast, such as removal of a lymph node or treatment for a skin condition called hidradenitis.
- People with a history of invasive breast cancer in the opposite breast, either in the past or occurring at the same time.
- People who are currently pregnant or breastfeeding.
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.
Contact this trial
Principal Investigator: Jamie Wagner, D.O., The University of Kansas Cancer Center
Phone: (913) 588-3671
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
Sponsor
University of Kansas Medical Center
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 July 2031
Primary endpoints
Disease Free Survival (DFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.