RecruitingPhase IIEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat.
  • Kobieta po menopauzie.
  • Dobry ogólny stan zdrowia (wynik ECOG 0-2).
  • Rak piersi w stopniu zaawansowania I-III, większy niż 10 mm, z dodatnimi receptorami HER2 i ER.
  • Rak piersi, który można usunąć operacyjnie i który wymaga leczenia przed operacją.
  • Dostępna próbka tkanki z biopsji diagnostycznej przed rozpoczęciem leczenia.
  • Zgodę na powtórzenie biopsji piersi 3 tygodnie po rozpoczęciu leczenia.
  • Prawidłowe wyniki badań krwi i narządów wewnętrznych (wątroba, nerki, serce).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
April 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

University of Illinois Cancer Center

Chicago, United States

University of Rochester Medical Center

Rochester, United States

Penn State Cancer Institute

Hershey, United States

University of Wisconsin

Madison, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.