Molecular Analyses for Endocrine Resistance in HR+ HER2- Breast Cancer

This study is looking at how breast cancer tumors change when treated with endocrine therapy before surgery. Researchers are giving patients with hormone receptor-positive (HR+), HER2-negative breast cancer either aromatase inhibitors or tamoxifen for 4-12 weeks before their surgery. The goal is to see how these treatments affect certain proteins in the tumor, specifically HER-1, HER-2, and HER-3 receptor tyrosine kinases. By comparing these protein levels before and after treatment, the study hopes to find ways to predict which patients will respond best to endocrine therapy and identify new treatment targets. You may be able to join if you are a woman aged 18 or older with stage I or II breast cancer that is clinically lymph node negative. The study plans to enroll 100 participants, but its current status is unclear.

Study design
This is an interventional study that will enroll 100 participants. It is an exploratory phase II study where all participants receive standard-of-care anti-estrogen treatment.
What's involved
You would receive either aromatase inhibitors or tamoxifen for 4-12 weeks before your surgery. Tumor samples will be taken at the time of surgery to measure protein changes.
Compensation
Not stated in the trial record.
Follow-up
Changes in protein expression are measured at the time of surgery.

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NCT06361940

Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical College of Wisconsin
~100 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Aromatase inhibitors or tamoxifen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors.
Measured over Time of surgery
+3 more outcomes measured
Breast Cancer
1 sites across 1 states
Wisconsin1
  • Lubna N Chaudhary, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Medical College of Wisconsin Cancer Center Clinical Trials Office
Email the study team

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  • Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors.Time of surgery

    Pathologists will use immunohistochemistry (IHC) to determine the average count of tumor protein expression. IHC is reported categorically as 0,1, 2 or 3. Any increase between these categories is considered increase.

  • Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors.Time of surgery

    Pathologists will use immunohistochemistry to determine the average count of tumor protein expression. IHC is reported categorically as 0,1,2 or 3. Any increase between these categories is considered increase.

  • Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors.Time of surgery

    Pathologists will use immunohistochemistry to determine the average count of tumor protein expression. IHC is reported categorically as 0,1,2 or 3. Any increase between these categories is considered increase.

  • Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors.Time of surgery

    Pathologists will use immunohistochemistry to determine the average count of tumor protein expression. IHC is reported categorically as 0,1,2 or 3. Any increase between these categories is considered increase.