A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
AstraZeneca
Study ID
NCT04538742
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    T-DXd: administered as an IV infusion
  • Durvalumab — DRUG
    Durvalumab: administered as an IV infusion
  • Paclitaxel — DRUG
    Paclitaxel: administered as an IV infusion
  • Pertuzumab — DRUG
    Pertuzumab: administered as an IV infusion
  • Tucatinib — DRUG
    Tucatinib administered orally (tablet) twice daily

Study Details

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Key Dates

Start date
Dec 28, 2020
Status verified
Dec 2025
Primary completion
Jan 31, 2025
Completion
Jan 31, 2030

Study Design

Enrollment
245 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1- T-DXd and Durvalumab
    T-DXd and Durvalumab
  • Experimental: Module 2- T-DXd and Pertuzumab
    T-DXd and Pertuzumab
  • Experimental: Module 3- T-DXd and Paclitaxel
    T-DXd and Paclitaxel (Arm not initiated in Part 2)
  • Experimental: Module 4- T-DXd and Durvalumab and Paclitaxel
    T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)
  • Experimental: Module 0- T-DXd
    T-DXd
  • Experimental: Module 5 - T-DXd and Tucatanib
    T-DXd and tucatinib (Arm not initiated in Part 2)
  • Experimental: Module 6 - T-DXd and Tucatinib
    T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)
  • Experimental: Module 7 - T-DXd
    T-DXd monotherapy in patients with active brain metastases (Part 2 Only)

Primary Outcome Measure

Occurrence of adverse events (AEs)- Part 1 [ Time Frame: Up to follow-up period, approximately 53 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteFort MyersFlorida33901-
Research SiteSt. PetersburgFlorida33705-
Research SiteCommackNew York11725-
Research SiteHarrisonNew York10604-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SiteColumbusOhio43219-
Research SiteNashvilleTennessee37203-
Research SiteFort WorthTexas76104-
Research SiteFairfaxVirginia22031-

Find similar trials in Fort Myers, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Fort Myers, FLResearch Site· St. Petersburg, FLResearch Site· Commack, NYResearch Site· Harrison, NYResearch Site· New York, NYResearch Site· Columbus, OH

Related Studies