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New treatment option for Anatomic Stage I Breast Cancer
Official title Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
ClinicalTrials.gov ID: NCT05919108
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 anatomic stage i breast cancer.
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
- This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
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
- Each patient will be entered into this study only if all of these criteria are met:
- people aged 18 years or older at signing of informed consent.
- New diagnosis of clinical stage I-III HR+ histologically-proven (i.e. absent or decreased e-cadherin expression) invasive lobular carcinoma
- Synchronous breast tumors are permitted as long as the synchronous tumor is ER+ and HER2-negative.
- ER+ disease defined as ≥1% estrogen receptor (ER) positive consistent with current American Society of Clinical Oncology/College of American...
You likely can't join if
- Evidence of distant metastatic disease
- Synchronous breast cancer that is estrogen receptor negative OR HER2-amplified OR requires treatment with neoadjuvant chemotherapy per the judgement...
- Patients harboring ineligible somatic HER2 mutations, such as those that are subclonal in nature or those resulting in the expression of truncated...
- Prior endocrine therapy for breast cancer within the last 2 years
- Women who are pregnant, are planning to become pregnant, or are breast-feeding
- Any investigational treatment for the current diagnosis of breast cancer
See the full eligibility criteria
- Each patient will be entered into this study only if all of these criteria are met:
- people aged 18 years or older at signing of informed consent.
- New diagnosis of clinical stage I-III HR+ histologically-proven (i.e. absent or decreased e-cadherin expression) invasive lobular carcinoma
- Synchronous breast tumors are permitted as long as the synchronous tumor is ER+ and HER2-negative.
- ER+ disease defined as ≥1% estrogen receptor (ER) positive consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO)...
- At the time of screening, histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified or...
- Archival tissue availability (if not available a fresh tumor biopsy will be required) and subject must agree to submission of sample for central testing
- Minimum tumor size of ≥1.5 cm by US, mammogram, MRI imaging, or clinical breast exam
- ECOG performance status 0 or 1
- Patients must have adequate hematologic, hepatic, and renal function. All laboratory tests must be obtained within 1 month of study entry. This includes:
- Estimated glomerular filtration rate of ≥50 mL/min
- Albumin ≥ 2.5 g/dL
- ANC ≥1500/mm\^3
- Platelet count ≥100,000/mm\^3
- HgB ≥ 9 g/dL
- Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)
- AST and ALT ≤ 3 x ULN
- Pre-, peri-, or post-menopausal, confirmed by history or laboratory testing as needed
- Diagnostic biopsy tissue availability with sufficient tumor to permit NGS (if not available, a fresh biopsy will be required)
- No prior treatment for current diagnosis of breast cancer
- For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and/or uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms...
- Age ≥ 55 years
- Age ≤ 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range. Female participants...
- Evidence of distant metastatic disease
- Synchronous breast cancer that is estrogen receptor negative OR HER2-amplified OR requires treatment with neoadjuvant chemotherapy per the judgement of the treating physician
- Patients harboring ineligible somatic HER2 mutations, such as those that are subclonal in nature or those resulting in the expression of truncated proteins including alterations that result in premature stop codon or a...
- Prior endocrine therapy for breast cancer within the last 2 years
- Women who are pregnant, are planning to become pregnant, or are breast-feeding
- Any investigational treatment for the current diagnosis of breast cancer
- HER2 amplification by FISH (HER2:CEP17 ratio \>2.0) or IHC (HER2 (3+)
- Hepatic function impairment as defined by AST or ALT \> 3x ULN OR total serum bilirubin \> 1.5 (in patients with known Gilbert syndrome, a total bilirubin of \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN)
- Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade ≥2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0...
- Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the Investigator's judgment, make the patient inappropriate for this study.
- Known hypersensitivity to any component of the investigational product, required combination therapy, or loperamide.
- Unable or unwilling to swallow tablets.
- Unable or unwilling to complete study procedures such as research biopsies or imaging
- Any medical condition that in the judgement of the co-investigator would impair the patient's ability to complete the planned study therapy
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, 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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Atlanta, Georgia, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States; Dallas, Texas, United States; Houston, Texas, 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.