Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

About this Study

The purpose of this study is to see if investigational drug trastuzumab deruxtecan, either alone or in combination with another medication, pertuzumab, is effective in treating patients with Human epidermal growth factor receptor 2 (HER2) positive breast cancer as a first line of treatment.  Study will also allow us to better understand the studies disease and associated health problems.

Sponsor Protocol ID:D967UC00001
IRB Number:2021-1029
Actively Enrolling
Interventional
Phase 3
April 28, 2022
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
  • Must be 18 years of age or older
  • Male and female
  • Breast cancer that is advanced or metastatic, HER2 positive
  • No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer
  • At least 1 lesion, not previously irradiated
  • LVEF greater than 50% within 28 days before randomization
  • Minimum life expectancy of greater than 12 weeks at screening

Exclusion Criteria
  • Ineligible for any of the agents on the study
  • History of abnormal heart rhythm
  • History of (non-infectious) ILD/pneumonitis
  • Any concurrent anticancer treatment
  • Palliative radiotherapy with a limited field of radiation within 2 weeks
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment or and anticipated need for major surgery during the study
  • Enrolled in another study with a study treatment¬†
  • Pregnant or breastfeeding female patient

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessie Solise
Phone Number: 601-984-1963
Email: jsolise@umc.edu
Principal Investigator:Tang, Shou-Ching, M.D.Ph.D., M.D., Ph.D.
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