Study on Neratinib Before Main Treatment for Stage I-III HER2-Mutated Lobular Breast Cancers

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05919108

Provider View

This clinical trial is exploring how well the drug neratinib works when given before the main treatment for patients with stage I-III HER2-mutated lobular breast cancer. Neratinib is a type of medication that blocks proteins that help cancer cells grow, potentially slowing or stopping the spread of cancer.

Patient Parameters

Program Overview

The purpose of this phase II study is to see if taking neratinib before the main treatment can help treat patients with stage I-III HER2-mutated lobular breast cancer. Neratinib is a kinase inhibitor that works by blocking abnormal proteins that signal cancer cells to multiply. This study aims to find out if adding neratinib to the usual therapy is more effective than the standard endocrine therapy alone.

Description

PRIMARY OBJECTIVE:

  • To determine how effective neratinib is when combined with endocrine therapy before the main treatment.

SECONDARY OBJECTIVES:

  • To evaluate additional outcomes of using neratinib with endocrine therapy.
  • To compare the safety and tolerability of neratinib plus endocrine therapy.

CORRELATIVE OBJECTIVE:

  • To create HER2-mutant invasive lobular carcinoma (ILC) organoids for research.

STUDY OUTLINE:

Participants are randomly assigned to one of two treatment groups.

TREATMENT A: Participants receive standard endocrine therapy for 4 weeks. They will have a breast tissue biopsy during this time. Then, they will take neratinib daily for 20 weeks, unless the cancer progresses or side effects become unacceptable. Surgery will occur during weeks 24-25. Blood samples will be collected every 4 weeks, at weeks 4 and 24, and during surgery. Imaging tests like mammograms or MRIs will be done before surgery.

TREATMENT B: Participants receive both endocrine therapy and neratinib for 4 weeks. They will have a breast tissue biopsy during this time. Then, they will continue taking neratinib daily for 20 weeks, unless the cancer progresses or side effects become unacceptable. Surgery will occur during weeks 24-25. Blood samples will be collected every 4 weeks, at weeks 4 and 24, and during surgery. Imaging tests like mammograms or MRIs will be done before surgery.

After completing the study treatment, participants will be followed up for 4 weeks after stopping the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Newly diagnosed with stage I-III HR+ invasive lobular carcinoma.
  • Can have multiple breast tumors if they are ER+ and HER2-negative.
  • Cancer must be ER+ (at least 1% estrogen receptor positive).
  • Must have a confirmed HER2 mutation by a certified lab.
  • Must provide a tumor sample for testing.
  • Tumor must be at least 1.5 cm in size.
  • Must be in good overall health (ECOG status 0 or 1).
  • Must have adequate blood, liver, and kidney function.
  • Must be pre-, peri-, or post-menopausal.
  • Must not have had prior treatment for the current breast cancer diagnosis.
  • Must agree to use effective contraception during and after the study if not postmenopausal or surgically sterile.

Exclusion Criteria

  • Evidence of cancer spread to distant parts of the body.
  • Other breast cancer that is ER-negative or HER2-amplified.
  • Ineligible HER2 mutations.
  • Prior endocrine therapy for breast cancer within the last 2 years.
  • Pregnant, planning to become pregnant, or breastfeeding.
  • Any investigational treatment for the current breast cancer diagnosis.
  • HER2 amplification by specific tests.
  • Liver function impairment.
  • Significant gastrointestinal disorders with diarrhea.
  • Significant medical or psychiatric conditions that could affect participation.
  • Known allergy to study drugs.
  • Unable or unwilling to swallow tablets or complete study procedures.

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