Study on DATOpotamab Deruxtecan for Breast Cancer That Has Spread to the Brain

Sponsor: Sarah Sammons, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06176261

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, datopotamab deruxtecan, for patients with breast cancer that has spread to the brain. The drug is a type of antibody-drug conjugate designed to target cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the drug datopotamab deruxtecan is for treating breast cancer that has spread to the brain. This drug is a new type of treatment called an antibody-drug conjugate, which targets specific molecules on cancer cells. The study involves different groups of participants based on their type of breast cancer, including those with estrogen receptor-positive, HER2-negative breast cancer, triple-negative breast cancer, and HER2-negative breast cancer that has spread to the areas surrounding the brain or spinal cord. Participants will undergo various procedures, including blood tests, imaging scans, and treatment visits. The study is sponsored by Daiichi Sankyo Inc., and about 58 people are expected to participate.

Description

This study is a phase II trial that aims to test the safety and effectiveness of datopotamab deruxtecan in patients with HER2-negative breast cancer that has spread to the brain. Participants will be divided into three groups based on their cancer type: estrogen receptor-positive, HER2-negative breast cancer; triple-negative breast cancer; and HER2-negative breast cancer that has spread to the brain's surrounding areas. The drug, datopotamab deruxtecan, is an antibody-drug conjugate that targets cancer cells with a specific molecule. The FDA has not yet approved this drug for treating HER2-negative metastatic breast cancer. Participants will undergo screening, blood tests, imaging scans, and other procedures as part of the study. The study is funded by Daiichi Sankyo Inc., and approximately 58 participants will be involved.

Eligibility Criteria

Exclusion Criteria

  • Severe or urgent medical conditions requiring immediate treatment, such as a visceral crisis or urgent neurosurgery.
  • Need for immediate local treatment of brain lesions.
  • Significant bleeding in the brain or more than two seizures in the last four weeks.
  • Ongoing side effects from previous cancer treatments that have not improved.
  • Inability to undergo MRI due to medical devices or conditions, though CT scans may be used if necessary.
  • Use of other cancer treatments during the study is not allowed, but supportive care medications are permitted.
  • Uncontrolled illnesses, such as infections, heart problems, or severe malnutrition.
  • Need for ongoing high-dose steroid treatment.
  • History of lung disease requiring steroids or current lung issues.
  • History of uncontrolled seizures or significant mental health issues.
  • History of other cancers, except for certain skin cancers or other cancers treated successfully over three years ago.
  • Recent major surgery or injury.
  • Significant eye disease.
  • Severe allergic reactions to the study drug or similar drugs.
  • Women must not be pregnant or breastfeeding and must use effective birth control during and after the study.
  • Men must use contraception to prevent pregnancy in partners during and after the study.

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