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

ConditionsAnatomic Stage I Breast CancerAnatomic Stage II Breast CancerAnatomic Stage III Breast CancerInvasive Breast Lobular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endocrine Therapy

    Procedure/Surgery

    Undergo endocrine therapy

  • Biopsy of breast

    Procedure/Surgery

    Undergo breast biopsy

  • Neratinib

    Drug

    Taken by mouth

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Mammogram

    Procedure/Surgery

    Undergo Mammogram

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo breast Magnetic Resonance Imaging

  • Breast Surgery

    Procedure/Surgery

    Undergo Breast Surgery

  • Ultrasound

    Procedure/Surgery

    Undergo Ultrasound

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Treatment A (endocrine therapy)Active comparator 7 interventions
Group B: Treatment B (endocrine therapy, neratinib)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Preoperative endocrine prognostic index score

Time frame
Up to 5 years

Secondary outcomes

1

Pathological complete response rate

Will be summarized for the entire cohort by response.

Time frame
Up to 5 years
2

Change in Ki67

Time frame
At 4 weeks
3

Residual cancer burden index

Will be summarized for the entire cohort by response

Time frame
Up to 5 years
4

Rates of breast conservation therapy

Will be summarized for the entire cohort by response

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Puma Biotechnology, Inc.

Collaborator

Source ClinicalTrials.gov
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