Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Trial Details

NCT ID
NCT04886531
Phase
PHASE2
Sponsor
Ruth O'Regan
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Neratinib
  • Letrozole (L) or Anastrozole (A)
  • Trastuzumab
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Rochester, New York, United States|43.15478,-77.61556
  • Hershey, Pennsylvania, United States|40.28592,-76.65025
  • Madison, Wisconsin, United States|43.07305,-89.40123

Key Eligibility Criteria

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the infor…
  • Age ≥ 18 years at the time of consent.
  • Postmenopausal females. NOTE: Postmenopausal status defined as: prior bilateral oophorectomy, Age ≥ 60 years, or Age \< 60 years and amenorrhea for…

For full eligibility, visit ClinicalTrials.gov.

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