T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

Trial Details

NCT ID
NCT07683754
Phase
PHASE3
Sponsor
Daiichi Sankyo
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Trastuzumab deruxtecan
  • Trastuzumab
  • Pertuzumab
  • Endocrine Therapy
  • Palbociclib
Locations (sample)
  • Columbia, Maryland, United States|39.24038,-76.83942
  • Las Vegas, Nevada, United States|36.17497,-115.13722
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • El Paso, Texas, United States|31.75872,-106.48693
  • New Braunfels, Texas, United States|29.703,-98.12445

Key Eligibility Criteria

  • Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.
  • Participant must be ≥18 years of age at the time the ICF is signed.
  • Have pathologically documented breast cancer that:
  • Is locally advanced and unresectable or metastatic (participants who can be treated with curative intent are not eligible).

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →