Study on Dato-DXd for Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07205822

Provider View

This clinical trial is testing the effectiveness and safety of a new drug, Dato-DXd, for patients with advanced breast cancer that is hormone receptor-positive and HER2 IHC 0. The study focuses on patients whose cancer cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Dato-DXd works and how safe it is for patients with advanced breast cancer that is hormone receptor-positive and HER2 IHC 0. This type of breast cancer does not respond to hormone therapy and cannot be surgically removed or has spread. Participants will receive Dato-DXd through an IV every three weeks. The study will monitor the cancer's response to the treatment and any side effects.

Description

This study involves treating about 100 participants with Dato-DXd, given as an IV infusion every three weeks. The treatment will continue until the cancer progresses, side effects become unacceptable, or the participant decides to stop. Participants must provide a tumor sample before starting the treatment and may need to provide additional samples during the study. Imaging tests will be done every 8 weeks for the first 48 weeks, then every 12 weeks to monitor the cancer's response. Participants will also have regular blood tests to check for biomarkers that might predict how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced breast cancer that is hormone receptor-positive and HER2 IHC 0, meaning it does not respond to hormone therapy and cannot be surgically removed or has spread.
  • Cancer must have progressed after hormone therapy and not suitable for further hormone treatment.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Provide a tumor sample before starting treatment.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have adequate blood cell counts and organ function.
  • Agree to use effective contraception during the study and for a specified time after the last dose of Dato-DXd.
  • Be able to give informed consent and comply with study requirements.
  • All races, genders, and ethnic groups are eligible.

Exclusion Criteria

  • Have severe or uncontrolled diseases or conditions that make participation unsafe.
  • Have another active cancer within the last 3 years, except for certain skin cancers or in situ cancers.
  • Have unresolved side effects from previous cancer treatments.
  • Have untreated or unstable brain or spinal cord cancer spread.
  • Have significant fluid buildup in the body that cannot be managed.
  • Have active or uncontrolled hepatitis B or C, or uncontrolled HIV infection.
  • Have uncontrolled infections or tuberculosis.
  • Have significant heart or lung disease.
  • Have had certain previous cancer treatments or are currently receiving other cancer treatments.
  • Have had major surgery recently or need major surgery during the study.
  • Are pregnant or breastfeeding, or planning to become pregnant.
  • Have a history of severe allergic reactions to similar drugs.
  • Are participating in another clinical trial or have recently participated in one.

Locations

FACILITYZIPCITYSTATE
Research Site33770LargoFlorida
Research Site46825Fort WayneIndiana
Research Site68130OmahaNebraska
Research Site10021New YorkNew York
Research Site77024HoustonTexas
Research Site98373PuyallupWashington

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