Phase 2 Breast Cancer Trial, Recruiting NCT05559164 Sponsor: Rutgers, The State University of New Jersey Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05559164
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 have been diagnosed with Stage I–III breast cancer (including inflammatory breast cancer), confirmed by laboratory testing of tissue or cell samples
  • People who are scheduled to receive neoadjuvant or adjuvant (before or after surgery) treatment that targets the HER2 protein
  • People aged 18 or older
  • People of childbearing potential who have a negative pregnancy test before enrolling and who agree to use effective barrier contraception throughout treatment
  • People whose heart is pumping at 50% or above (as measured before the trial begins)
  • People who have had a previous cancer diagnosis, provided there has been no sign of that cancer for the past 5 years
  • People with a general physical fitness level rated as ECOG 0–2, meaning they are fully active to capable of limited self-care (confirm with trial site)
  • People who have never previously been treated with HER2-targeted therapy or anthracycline-based chemotherapy
  • People whose blood counts meet minimum levels — including white blood cells, platelets, and haemoglobin — as confirmed by blood tests
  • People whose liver function blood test results fall within acceptable ranges as confirmed by blood tests
  • People whose kidneys are functioning at an adequate level, as measured by blood tests or a standard calculation
  • People who are able to understand the study and provide written informed consent
  • People who are willing and able to attend scheduled visits, follow treatment plans, and complete all required study procedures

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 who are currently taking statin medications (commonly used for cholesterol)
  • People with high blood pressure that is not well controlled (above 190/100 mmHg)
  • People with active liver disease
  • People currently taking medications known as CYP 3A4 inhibitors (a group of drugs that affect how other medicines are broken down in the body — confirm with trial site)
  • People whose overall health or lab results put them at unacceptable risk in the trial, as judged by the investigating doctor
  • People with a life expectancy of less than 12 weeks
  • People who are pregnant (positive pregnancy test) or breastfeeding
  • People who already have nerve damage (sensory neuropathy) rated above a mild level (Grade 1) before the trial begins
  • People with significant heart conditions, including: a heart pumping rate below 50%, Class III or IV heart disease as classified by the New York Heart Association, a heart attack within the past 6 months, or symptomatic irregular heartbeat at the time of joining
  • People who have had major surgery in the past 4 weeks and have not fully recovered
  • People who have a current active infection
  • People with uncontrolled or active HIV, Hepatitis B, or Hepatitis C infection
  • People who have a known allergy or hypersensitivity to any of the study drugs
  • People with a history of certain lung conditions, including interstitial lung disease, pulmonary fibrosis, sarcoidosis, silicosis, or hypersensitivity pneumonitis
  • People with any significant medical condition, abnormal lab results, or psychiatric illness that would prevent safe participation in the study

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

If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

  • Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
  • Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
  • Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
  • Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
  • Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Mridula George, MD, Rutgers Cancer Institute of New Jersey

Phone: 732-235-9081

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
Rutgers, The State University of New Jersey
Registry
ClinicalTrials.gov
Start date
19 September 2022
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years

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