BridgeMD
New treatment option for Breast Cancer
Official title Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
ClinicalTrials.gov ID: NCT04886531
What this study is testing
What is Neratinib?
Neratinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Nerlynx.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must meet all of the following applicable 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...
- 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...
- ECOG Performance Status of 0-2 within 28 days prior to registration.
You likely can't join if
- people 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 how well it works...
- Active infection requiring systemic therapy.
- Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study (see protocol).
See the full eligibility criteria
- Subject must meet all of the following applicable 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...
- 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
- Hepatic
- 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)...
- 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.
- people 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 how well it works assessment of the investigational regimen are not eligible for this...
- 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...
- Known history of myelodysplastic syndrome or acute myeloid leukemia.
- people 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Rochester, New York, United States
- Hershey, Pennsylvania, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Rochester, New York, United States; Hershey, Pennsylvania, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.