Study on Predicting Endocrine Resistance in Hormone Receptor-Positive HER2-Negative Breast Cancer

Sponsor: Medical College of Wisconsin

Sponsor score: 0

ClinicalTrials ID:NCT06361940

Provider View

This study explores how short-term anti-estrogen treatment before surgery can help predict how breast cancer responds to hormone therapy. It focuses on patients with hormone receptor-positive, HER2-negative breast cancer.

Patient Parameters

Program Overview

This research is looking at how breast cancer tumors respond to hormone therapy given before surgery. Typically, patients with hormone receptor-positive, HER2-negative breast cancer have surgery first, followed by hormone therapy. This study gives hormone therapy before surgery to see how the tumors react, which can help predict how well the treatment works. By examining changes in the tumor at the molecular level before and after treatment, researchers hope to find markers that indicate how well the cancer will respond to current treatments and identify new potential treatment targets.

Description

Patients with hormone receptor-positive, HER2-negative breast cancer usually have surgery to remove the tumor, followed by hormone therapy and possibly chemotherapy. However, when hormone therapy is given after surgery, it's hard to see how the tumor responds to the treatment. This study offers a chance to see how tumors react to hormone therapy before surgery. By comparing the tumor's molecular markers before and after treatment, researchers aim to find indicators of how well the cancer responds to current treatments and discover new treatment targets. This could help tailor treatments to individual patients in the future.

Eligibility Criteria

Inclusion Criteria

  • Have a breast mammogram and ultrasound within 60 days before joining the study.
  • Diagnosed with invasive breast cancer, stage I or II.
  • No cancer in the lymph nodes, confirmed by exam or ultrasound.
  • Must be female and at least 18 years old.
  • Tumor must be positive for estrogen and/or progesterone receptors.
  • Tumor must be negative for HER2.
  • Must be in good overall health, with a performance status of 0 to 2.
  • Can have cancer in both breasts or multiple areas in one breast.
  • Must have no signs of cancer spread to other parts of the body.
  • Must be eligible for hormone therapy as determined by a doctor.
  • Must agree to participate and sign a consent form.
  • Can have a history of breast cancer if treatment was completed over two years ago.
  • Must not have had treatment for this breast cancer or any other cancer in the past two years, except for certain skin or cervical cancers.
  • Women of childbearing age must use effective birth control.
  • Must not use certain medications that interfere with tamoxifen.

Exclusion Criteria

  • Advanced breast cancer with large tumors or cancer spread to lymph nodes or other parts of the body.
  • Having another type of cancer at the same time, except for certain skin or cervical cancers.
  • Having only non-invasive breast cancer.
  • Men with breast cancer.
  • Any medical or psychiatric condition that prevents participation or understanding of the study.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Froedtert Hospital and the Medical College of Wisconsin53226MilwaukeeWisconsin

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