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

Conditions

• Anatomic Stage I Breast Cancer
• Anatomic Stage II Breast Cancer
• Anatomic Stage III Breast Cancer
• Invasive Breast Lobular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Endocrine Therapy — PROCEDURE
  Undergo endocrine therapy
• Biopsy of breast — PROCEDURE
  Undergo breast biopsy
• Neratinib — DRUG
  Taken by mouth
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Mammogram — PROCEDURE
  Undergo Mammogram
• Magnetic Resonance Imaging — PROCEDURE
  Undergo breast Magnetic Resonance Imaging
• Breast Surgery — PROCEDURE
  Undergo Breast Surgery
• Ultrasound — PROCEDURE
  Undergo Ultrasound

Study Details

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.

Key Dates

Start date

May 30, 2024

Status verified

Sep 2025

Primary completion

Apr 30, 2030

Completion

Apr 30, 2031

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Treatment A (endocrine therapy)
  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 PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.
• Experimental: Treatment B (endocrine therapy, neratinib)
  Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

Primary Outcome Measure

Preoperative endocrine prognostic index score [ Time Frame: Up to 5 years ]

Central Contacts

• Vanderbilt-Ingram Services for Timely Access
  800-811-8480
  [email protected]

Locations (5)

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