Phase 2 Breast Cancer Trial, Recruiting NCT05464082 Sponsor: University of Utah Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05464082
Recruiting Phase 2

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 18 years of age or older.
  • People who have been diagnosed with early-stage breast cancer (Stage I, II, or III).
  • People whose breast cancer has been confirmed by laboratory testing to be either triple-negative breast cancer (TNBC) or a type with very low hormone receptor activity and negative for a protein called HER2 — the trial site can explain what these test results mean.
  • People whose main breast tumour or a nearby affected lymph node measures at least 1.5 cm. People with inflammatory breast cancer may be eligible regardless of tumour size. People with more than one tumour site may be eligible if all tumours meet the required test results and at least one measures 1.5 cm or more.
  • People who are being considered for chemotherapy before surgery, either as standard care or as part of a separate clinical trial.
  • People who have not yet received any treatment for their current breast cancer diagnosis.
  • People whose tumour can be safely accessed for a tissue sample collection, including where blood-thinning medications can be safely paused if needed.
  • People whose treating doctor assesses them as having a life expectancy of at least 12 months.
  • People whose general physical functioning is assessed by their doctor as reasonably good (based on a standard medical scale called the ECOG scale, scored 0–2) (confirm with trial site).
  • Women who are post-menopausal, or women who are pre-menopausal and have a negative pregnancy test. There are specific definitions used to determine post-menopausal status depending on age — the trial site can confirm which applies.
  • People who are willing and able to give formal written consent to participate.
  • People with a previous history of hormone receptor-positive breast cancer may still be eligible if all treatments aimed at curing that earlier cancer have been completed (except for ongoing hormonal maintenance therapy) and at least 6 months have passed since finishing those treatments before the current breast cancer was diagnosed.

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 whose breast cancer has spread to other parts of the body (metastatic breast cancer).
  • People whose breast cancer tests show high levels of hormone receptors (more than 10% of cells positive for oestrogen or progesterone receptors).
  • People whose breast cancer tests show high levels of the HER2 protein or HER2 gene amplification (confirm with trial site for specific test thresholds).
  • People who have cancer in both breasts at the same time.
  • People who have already received any cancer treatment — including chemotherapy, radiation, hormonal therapy, or other anti-cancer therapies — for their current breast cancer diagnosis before joining the trial.
  • People who have been diagnosed with another cancer, unless they have been considered cancer-free for at least 5 years before joining. Some earlier-stage or low-risk cancer diagnoses (such as certain skin cancers, early cervical cancer in situ, or early thyroid cancer) may still be eligible — the trial site can advise on specific cases.
  • People with serious uncontrolled heart conditions, such as a recent heart attack (within the past 3–6 months), severe heart failure, or dangerous irregular heart rhythms.
  • People with serious kidney or liver disease that would prevent them from receiving a full dose of chemotherapy.
  • People who have had a stroke, blood clot, or similar cardiovascular event within the past 3 months.
  • People with certain other heart-related measurements outside safe limits, including a specific electrical reading of the heart (QTcF above 500 ms), a known inherited heart condition called long QT syndrome, reduced heart pumping strength, or blood pressure that is not controlled and consistently high (confirm with trial site for specific thresholds).
  • People with any other medical, psychological, or social condition that, in the treating doctor's judgement, would make participation unsafe or make it difficult to follow the study procedures.
  • People who have difficulty understanding the study information, giving consent, or following the study requirements for any medical, psychiatric, or cognitive reason.

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 30 July 2026

Contact this trial

Principal Investigator: Christos Vaklavas, MD, Huntsman Cancer Institute

Phone: 801-585-0571

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
6 January 2023
Est. completion
30 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of cases where clinically actionable therapies were identified by FPO.; Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-); Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)

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: 30 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