Study on New Treatment Strategy for Metastatic Breast Cancer Using Approved Drugs

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40

ClinicalTrials ID:NCT06409390

Provider View

This clinical trial is exploring a new way to use existing medications to treat metastatic breast cancer, aiming to find a more effective treatment method.

Patient Parameters

Program Overview

The study aims to test a new treatment strategy using currently approved drugs to see if administering them in a different way could be more effective for patients with metastatic breast cancer. Researchers hope this approach will improve treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with hormone-positive, HER2-negative metastatic breast cancer, confirmed by a biopsy.
  • Previously treated with hormone therapy, such as an aromatase inhibitor or Tamoxifen, possibly combined with a CDK4/6 inhibitor.
  • Elevated breast tumor markers, such as CA 15-3, CA 27-29, or CEA, above normal levels.
  • Have measurable disease on imaging scans.
  • In good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ and bone marrow function.
  • Negative pregnancy test for women who can become pregnant.
  • Women who can become pregnant must agree to use effective birth control during the study.
  • Open to all races and ethnic groups who meet the criteria.
  • Willing to follow all study procedures and available for the study duration.
  • Able to understand and sign a consent form, or have a representative do so.

Exclusion Criteria

  • Have previously been treated with Fulvestrant for breast cancer.
  • Have allergies to the study drugs.
  • Have brain metastasis or active/newly diagnosed cancer in the central nervous system.
  • Have taken any investigational drugs within 30 days before starting the study.
  • Have another cancer diagnosis or treatment within the last 2 years, unless it's non-melanoma skin cancer or carcinoma in situ that has been completely removed.
  • Have uncontrolled illnesses, such as infections, heart failure, unstable chest pain, or psychiatric conditions that would interfere with the study.
  • Have advanced cancer spread to organs that could cause life-threatening complications soon.
  • Have a known history of HIV or AIDS.
  • Have active infections like tuberculosis, hepatitis B, or hepatitis C, unless resolved or under control.
  • Have used immunosuppressive medication within 14 days before starting the study, with some exceptions for low-dose steroids or premedication for allergies.
  • Unable to follow the study protocol.
  • Pregnant or breastfeeding women are not eligible.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center33612TampaFlorida

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