Study on Patritumab Deruxtecan and Trastuzumab Deruxtecan for Advanced Breast Cancer

Sponsor: Daiichi Sankyo

Sponsor score: 40

ClinicalTrials ID:NCT07701941

This clinical trial is testing a combination of two drugs, Patritumab Deruxtecan and Trastuzumab Deruxtecan, to see if they are safe and effective in treating patients with advanced breast cancer that is hormone receptor-positive and has low levels of HER2 protein.

Patient Parameters

Program Overview

The main goal of this study is to evaluate the safety and effectiveness of combining two drugs, HER3-DXd and T-DXd, in treating patients with advanced breast cancer that cannot be surgically removed or has spread to other parts of the body. The study focuses on patients whose cancer is hormone receptor-positive and has low or very low levels of HER2 protein.

Eligibility Criteria

Inclusion Criteria

  • Have breast cancer that cannot be surgically removed or has spread to other parts of the body.
  • Cancer must be hormone receptor-positive, meaning it has estrogen or progesterone receptors.
  • Cancer must have low or very low levels of HER2 protein, as determined by specific tests.
  • Provide a tumor sample from a recent biopsy or a new biopsy if needed.
  • Cancer must have shown progression after previous treatment.
  • Must have tried hormone therapy for advanced cancer and it is no longer effective.
  • Have previously used a CDK4/6 inhibitor.
  • If eligible for other targeted therapies, must have tried them unless not available or suitable.
  • No prior chemotherapy for advanced breast cancer, but previous chemotherapy for early-stage cancer is allowed.
  • Be in good overall health with a performance status of 0 or 1.
  • Have at least one measurable tumor on a scan.
  • Have adequate blood cell counts and organ function based on recent tests.

Exclusion Criteria

  • Have previously been treated with anti-HER3 drugs or similar therapies.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Are taking high doses of steroids or other immunosuppressive drugs.
  • Have active or untreated brain or spinal cord metastases.
  • Have not had enough time since previous treatments before starting the study.
  • Have uncontrolled heart conditions or significant heart disease.
  • Have had another active cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have unresolved side effects from previous cancer treatments.
  • Have allergies to the study drugs or their ingredients.

Locations

FACILITYZIPCITYSTATE
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute90048Los AngelesCalifornia
Stanford Medicine Cancer Center94305StanfordCalifornia
University of Colorado Denver - School of Medicine - Anschutz Medical Campus80045AuroraColorado
Yale University School of Medicine - Yale Cancer Center06510New HavenConnecticut
Massachusetts General Hospital02114BostonMassachusetts
Dana-Farber Cancer Institute02216BostonMassachusetts
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center10065New YorkNew York
Compass Oncology - Rose Quarter Cancer Center97227PortlandOregon
The West Cancer Center38138MemphisTennessee
SCRI Oncology Partners37203NashvilleTennessee

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