Is NCT04886531 recruiting in Hershey, PA?

Yes, NCT04886531 is currently recruiting participants at its Hershey, PA location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Hershey?

To join this clinical trial in Hershey, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Hershey clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Hershey, PA

About This Breast Cancer Study in Hershey

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Sponsor: Ruth O'Regan

Who Can Participate

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this study:

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent.

Postmenopausal females. NOTE: Postmenopausal status defined as: prior bilateral oophorectomy, Age ≥ 60 years, or Age \< 60 years and amenorrhea for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or an estradiol level in postmenopausal ranges per local reference range.

ECOG Performance Status of 0-2 within 28 days prior to registration.

Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm

HER2-positive (by the most recent ASCO-CAP criteria)

ER positive (≥ 10%). NOTE: There is no requirement for PR status; PR positive or negative allowed.

Resectable breast cancer in which pre-operative therapy is appropriate (T \> 10mm and/or node-positive).

Archival tissue from the diagnostic pre-treatment biopsy is required. This sample should be identified at screening and shipped by Week 4. If archival tissue is not available, the subject is not eligible for the study.

Agreeable to repeat breast biopsy at 3 weeks after initiation of treatment.

Candidate for either letrozole or anastrozole, as determined by the treating physician

Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 4 weeks prior to the study treatment.

Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.

Hematological

Platelet count ≥100,000/uL

Absolute Neutrophil Count (ANC) ≥1500/uL

Hemoglobin (Hgb) ≥10 g/dL

Renal ---Calculated creatinine clearance: CrCl ≥30 mL/min using the Cockcroft-Gault formula

Bilirubin ≤1.5 x upper limit of normal (ULN)

Aspartate aminotransferase (AST) ≤ 2.5 × ULN

Alanine aminotransferase (ALT) ≤ 2.5 × ULN

HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.

For patients with known serologic evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.

Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.

Exclusion Criteria

Subjects meeting any of the criteria below may not participate in the study:

Locally advanced or inflammatory breast cancer. NOTE: Locally advanced is defined as Stage IIIC or greater.

Evidence of metastatic disease. Systemic imaging is not required.

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial: exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.

Active infection requiring systemic therapy.

Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study (see protocol).

Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.

Subject has had major surgery within 14 days prior to registration or has not recovered from major side effects of the surgery (tumor biopsy is not considered as major surgery).

Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) or significantly impair the ability to swallow capsules/tablets.

Known history of myelodysplastic syndrome or acute myeloid leukemia.

Subjects with any of the following conditions:

History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration.

Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration.

History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration.

Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current cardiomyopathy with left ventricular ejection fraction (LVEF) \<50%.

Clinically significant cardiac ventricular arrhythmias (e.g. sustained ventricular tachycardia/ventricular fibrillation) or high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) unless a pacemaker is in place.

Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.

Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol.

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 Hershey?

Yes, this clinical trial (NCT04886531) has an active research site in Hershey, PA 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.

Breast Cancer Treatment Options in Hershey, PA

If you're searching for breast cancer treatment options in Hershey, PA, this clinical trial (NCT04886531) 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 Hershey research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced 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 breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Hershey, PA

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