Toms River, NJNCT07402473Now EnrollingIRB Ready

HER2-positive Early-stage Breast Cancer Clinical Trial in Toms River, NJ

Access cutting-edge her2-positive early-stage breast cancer treatment through this clinical trial at a research site in Toms River. Study-provided care at no cost to qualified participants.

Sponsored by Rutgers, The State University of New Jersey

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Expert Care in Toms River

Access her2-positive early-stage breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related her2-positive early-stage breast cancer treatment provided free

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Check if you qualify for this her2-positive early-stage breast cancer clinical trial in Toms River, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Toms River

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Toms River site if eligible
  4. 4Begin participation

About This HER2-positive Early-stage Breast Cancer Study in Toms River

This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design. Tumors will undergo testing using a novel molecular phosphoprotein-based biomarker assay, HER2 Activation Response Predictive Signature (HARPS) to identify HARPS-positive breast cancers. To assess 3-year invasive disease-free survival (iDFS) in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To correlate changes in ctDNA with treatment outcomes in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To understand the changes in quality of life (QOL) measure in patients with HARPS-positive HER2-positive breast cancer treated using an adaptive neoadjuvant trial design.

Sponsor: Rutgers, The State University of New Jersey

Who Can Participate

Inclusion Criteria

Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive.
Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry
Patient must have adequate tumor for HARPS testing.
Patients must have ctDNA collection prior to treatment on trial.
Patient must be able to do breast MRI as determined by the study
Baseline LVEF \> 50% (Most recent within the last 5 years)
No prior history of systemic treatment with anthracyclines-based chemotherapy.
Adequate bone marrow function:
ANC ≥ 1500/uL
platelet count ≥ 100,000/uL
hemoglobin ≥ 9.0 g/dL
Adequate hepatic function:
Total bilirubin ≤ 1.5 X ULN
AST (SGOT) ≤ 5 X ULN
ALT (SGPT) ≤ 5 X ULN
Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
Adequate renal function, Creatinine \< 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
Ability to understand the nature of this study protocol and give written informed consent.
Willingness and ability to comply with scheduled visits and treatment plans
Prior cancers allowed if no evidence of disease in last 5 years. Prior history of ipsilateral invasive breast cancers are not allowed.

Exclusion Criteria

Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. Exception: patients can start upto 1 cycle of HP prior to starting treatment on study.
cT4 and/or cN3 tumors
Evidence of metastatic disease by routine clinical assessment
Bilateral breast cancer
History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma
Left ventricular ejection fraction (LVEF) below 50% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO)
No active liver disease.
Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
Pre-existing sensory neuropathy \> grade 1.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
Serious non-healing wound, ulcer, or bone fracture
Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C.
Patient who has a history of allergy or hypersensitivity to any of the study drugs.
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Toms River?

Yes, this clinical trial (NCT07402473) has an active research site in Toms River, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HER2-positive Early-stage Breast Cancer Treatment Options in Toms River, NJ

If you're searching for her2-positive early-stage breast cancer treatment options in Toms River, NJ, this clinical trial (NCT07402473) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Toms River research site is actively enrolling participants for this clinical trial. You'll receive care from experienced her2-positive early-stage breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all her2-positive early-stage breast cancer clinical trials near you to find additional studies recruiting in your area.

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