Endocrine Therapy / Anatomic Stage III Breast Cancer / Neratinib · Phase 2 Trial

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration for neoadjuvant neratinib in HER2-mutated lobular breast cancer, currently recruiting. No results are posted in this registry record, so efficacy, safety, or any clinical outcome data are not yet available for review.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma; age from 18 Years. Intervention: Treatment B (endocrine therapy, neratinib). Compared with: Treatment A (endocrine therapy) — Active Comparator. n = 30. 5 sites: United States.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or outcome data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registration with no results reported; the study is still recruiting and no efficacy or safety data are available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Preoperative endocrine prognostic index score (assessed at Up to 5 years)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationAnatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma; age from 18 Years

Sample size30

InterventionTreatment B (endocrine therapy, neratinib)

ComparatorTreatment A (endocrine therapy) — Active Comparator

Setting5 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment30

Study phasePhase 2

Primary outcome measurePreoperative endocrine prognostic index score, up to 5 years

Caveats

This is a registry record with no results posted; no efficacy, safety, or outcome data are reported.
Study is still recruiting; no interim analysis or final results are available.
No control or comparator arm is mentioned in the registry description.
Primary outcome is a surrogate biomarker (preoperative endocrine prognostic index), not a hard clinical endpoint such as recurrence-free or overall survival.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional trial with neoadjuvant design; no control arm stated.

Directness

moderate

Primary outcome is preoperative endocrine prognostic index, a surrogate; not a hard clinical endpoint.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record only; no methods or results published to assess bias.

Sample adequacy

limited

Estimated enrollment 30 participants; modest sample for Phase 2.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05919108). This is a study registration, not published results. Lead sponsor: Vanderbilt-Ingram Cancer Center. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma. Interventions: PROCEDURE: Endocrine Therapy; PROCEDURE: Biopsy of breast; DRUG: Neratinib; PROCEDURE: Biospecimen Collection; PROCEDURE: Mammogram; PROCEDURE: Magnetic Resonance Imaging; PROCEDURE: Breast Surgery; PROCEDURE: Ultrasound. Primary outcome measures: Preoperative endocrine prognostic index score , Up to 5 years. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05919108Endocrine TherapyVanderbilt-Ingram Cancer CenterAnatomic Stage III Breast CancerNeratinibAnatomic Stage I Breast CancerBiopsy of breastAnatomic Stage Ii Breast CancerBiospecimen Collection