Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks, 20 weeks
- Procedures mentioned: Biopsies, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "TREATMENT A: Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle."
- "Patients undergo breast tissue biopsy during the lead-in window/cycle 1."
- "Patients then endocrine therapy and neratinib orally (PO) daily for 20 weeks in the absence of disease progression or unacceptable toxicity."
- "Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery."
- "TREATMENT B: Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle."
- "Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests neratinib before the main treatment for stage I–III lobular breast cancer, a cancer that starts in the breast's milk-making glands. It is for adults whose cancer responds to hormones and has a change in the HER2 gene. The study tests whether adding neratinib, which blocks signals that help cancer cells grow, may work better than usual hormone treatment.
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. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Newly diagnosed stage I–III lobular breast cancer confirmed by a tissue test. The cancer must respond to estrogen, a hormone.
- A lab test must confirm a HER2 gene change that makes the gene more active.
- The tumor must be at least 1.5 cm across.
- Able to do daily activities with little or no limits, and have blood counts, liver tests, and kidney tests within the study's required ranges.
- Have enough tumor tissue for study and gene testing, or agree to a new biopsy to collect tissue.
- Have had no treatment for the current breast cancer. People before, during, or after menopause may join.
- Follow the study's birth control rules during and after treatment. Men must continue birth control for 3.5 months afterward; women who could become pregnant must continue for at least 1 month. Hormonal birth control pills are not allowed.
Who can't join
- Cancer that has spread to distant parts of the body.
- Another breast tumor at the same time that does not respond to estrogen, has extra HER2, or needs chemotherapy before the main treatment.
- A HER2 gene change that does not qualify, or tests showing too many HER2 gene copies or too much HER2 protein.
- Hormone treatment for breast cancer within the past 2 years, or any experimental treatment for the current breast cancer.
- Pregnant, planning to become pregnant, or breastfeeding.
- Liver tests outside the study's limits, a serious long-term gut problem with diarrhea, or moderate or worse diarrhea when starting the study.
- An allergy to neratinib ingredients, required treatment drugs, or loperamide, a diarrhea medicine.
- Unable or unwilling to swallow tablets or complete study tests, such as biopsies and scans. Other health, mental health, or social problems may also prevent joining if they make treatment unsafe or hard to finish.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Each patient will be entered into this study only if all of these criteria are met: * Subjects 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) guidelines) * 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 equivalent laboratory. * 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, diaphragm, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as: * 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 of childbearing potential are eligible to participate if they agree to use a highly effective method of contraception that has a low user dependency consistently and correctly. Note: The effects of neratinib on the developing fetus are unknown and endocrine therapy is contraindicated in pregnancy. For this reason and because teratogenic effects have been observed in nonclinical studies and neratinib, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of the study participation, and for 1 month after the last dose of study medication. Should a woman become pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation and 3.5 months after completion of study treatment. Exclusion Criteria: * 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 change in reading frame (ie, frame shift mutations). * 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 \[CTCAE version 4.0\] diarrhea of any etiology at baseline. * 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
Study sites (5)
GA
- Emory University/ Winship Cancer Institute · Atlanta, GA 30322Kevin Kalinsky, MD · Principal investigatorMore trials in Atlanta
PA
- University of Pittsburgh Medical Center · Pittsburgh, PA 15213Adam Brufsky, MD · Principal investigatorMore trials in Pittsburgh
TN
- Vanderbilt University/Ingram Cancer Center · Nashville, TN 37203Vanderbilt-Ingram Service for Timely Access · Study contact · 800-811-8480 · cip@vumc.orgLaura Kennedy, MD, PhD · Principal investigatorMore trials in Nashville
TX
- University of Texas, Southwestern · Dallas, TX 75390Nisha Unni · Study contact · Nisha.Unni@UTSouthwestern.eduCarlos Arteaga, MD · Sub-investigatorNisha Unni, MD · Principal investigatorMore trials in Dallas
- Baylor College of Medicine · Houston, TX 77030Bora Lim, MD · Principal investigatorMore trials in Houston