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Studies

Interventional Active not recruiting Phase 3

NCT04784715 on ClinicalTrials.gov

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

Official title: 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)

  • Sponsor: AstraZeneca (Group)
  • Collaborators: Daiichi Sankyo
  • Enrollment: 1157 (Actual)
  • Study start: 2021-04-26 (Actual)
  • Primary completion: 2027-05-03 (Estimated)
  • Study completion: 2029-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Study will consist of three arms: Arm A - trastuzumab deruxtecan with pertuzumab-matching placebo Arm B - trastuzumab deruxtecan with pertuzumab Arm C - standard of care (taxane \[docetaxel or paclitaxel\], trastuzumab and pertuzumab)
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

Conditions

  • Breast Cancer; HER2-positive; Metastatic

Intervention / Treatment

  • Drug: Trastuzumab deruxtecan
  • Drug: Placebo
  • Drug: Taxane
  • Drug: Pertuzumab
  • Drug: Trastuzumab

Primary Outcome Measures

  • Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment (Until progression or death, assessed up to approximately 60 months)
    Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.

Countries

Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • Research Site, Tucson, United States
  • Research Site, Springdale, United States
  • Research Site, Glendale, United States
  • Research Site, Glendale, United States
  • Research Site, Longmont, United States
  • Research Site, Miami, United States
  • Research Site, Palm Bay, United States
  • Research Site, Plantation, United States
  • Research Site, Atlanta, United States
  • Research Site, Louisville, United States
  • Research Site, Silver Spring, United States
  • Research Site, Boston, United States
  • Research Site, Detroit, United States
  • Research Site, Jackson, United States
  • Research Site, Las Vegas, United States
  • Research Site, Summit, United States
  • Research Site, New York, United States
  • Research Site, Shirley, United States
  • Research Site, York, United States
  • Research Site, Germantown, United States
  • Research Site, Dallas, United States
  • Research Site, Dallas, United States
  • Research Site, Denton, United States
  • Research Site, Houston, United States
  • Research Site, San Antonio, United States
  • Research Site, Shenandoah, United States
  • Research Site, Tyler, United States
  • Research Site, Norfolk, United States
  • Research Site, Roanoke, United States
  • Research Site, Tacoma, United States
  • Research Site, Buenos Aires, Argentina
  • Research Site, CABA, Argentina
  • Research Site, CABA, Argentina
  • Research Site, Caba, Argentina
  • Research Site, Capital Federal, Argentina
  • Research Site, Cipolletti, Argentina
  • Research Site, Ciudad de Buenos Aires, Argentina
  • Research Site, La Plata, Argentina
  • Research Site, Mar del Plata, Argentina
  • Research Site, Rosario, Argentina
  • Research Site, Rosario, Argentina
  • Research Site, San Salvador de Jujuy, Argentina
  • Research Site, Brussels, Belgium
  • Research Site, Brussels, Belgium
  • Research Site, Charleroi, Belgium
  • Research Site, Edegem, Belgium
  • Research Site, Ghent, Belgium
  • Research Site, Leuven, Belgium
  • Research Site, Liège, Belgium
  • Research Site, Namur, Belgium

And 233 other sites.