Neratinib and Endocrine Therapy for HER2 Positive Breast Cancer

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

Recruiting Phase 2 Interventional Study
Breast Cancer HER2-positive Breast Cancer ER Positive Breast Cancer PR-Positive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Ruth O'Regan · Other
Who this trial is looking for

This trial is looking for women with certain types of breast cancer who can take part in a new treatment plan. Participants will receive a combination of treatments before their surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a postmenopausal female.
  • I have been diagnosed with invasive HER2-positive breast cancer.
  • I have been diagnosed with ER-positive breast cancer.
  • I am at least 18 years old.
  • I have a left ventricular ejection fraction of at least 50%.
  • I can agree to have a breast biopsy again during treatment.
  • My blood tests show I have adequate organ function.

You may not be able to join if

  • I have locally advanced or inflammatory breast cancer.
  • I have evidence of metastatic disease.
  • I have had major surgery in the last 14 days.
  • I have a history of severe heart problems.
  • I have an active infection needing treatment.
  • I have had gastrointestinal issues that could affect drug absorption.
  • I have a known history of certain blood disorders.
  • I currently take medications that strongly affect liver enzymes.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This 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 endocr…
Trial Locations
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Eligibility Criteria
Inclusion 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 informed consent or obtained separa…
Contacts

Ruth O'Regan, MD

608-265-9701

ruth_oregan@urmc.rochester.edu

CONTACT

Amber Ryba

317-634-5842

aryba@hoosiercancer.org

CONTACT