A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

Part of paid clinical trials in Commack, New York.

Sponsor
AstraZeneca
Study ID
NCT04556773
Phase
PHASE1
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
  • Capivasertib — DRUG
    Capivasertib: administered orally
  • Anastrozole — DRUG
    Anastrozole: administered orally
  • Fulvestrant — DRUG
    Fulvestrant: administered as an IM injection
  • Capecitabine — DRUG
    Capecitabine: administered orally

Study Details

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

Key Dates

Start date
Dec 17, 2020
Status verified
Dec 2025
Primary completion
Aug 16, 2023
Completion
Jun 16, 2026

Study Design

Enrollment
138 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: T-DXd + capecitabine
    T-DXd: 5.4 mg/kg Q3W, intravenous use Capecitabine: 1000mg/m2 BID, days 1-14 Q3W, oral use
  • Experimental: Module 2: T-DXd + durvalumab + paclitaxel
    T-DXd: 5.4 mg/kg Q3W, intravenous use Durvalumab: 1120 mg Q3W, intravenous use Paclitaxel: 80 mg/m2 QW in 3-week cycles, intravenous use
  • Experimental: Module 3: T-DXd + capivasertib
    T-DXd: 5.4 mg/kg Q3W, intravenous use Capivasertib: 400 mg BID, oral use
  • Experimental: Module 4: T-DXd + anastrozole
    T-DXd: 5.4 mg/kg Q3W, intravenous use Anastrozole: 1 mg daily, oral
  • Experimental: Module 5: T-DXd + fulvestrant
    T-DXd: 5.4 mg/kg Q3W, intravenous use Fulvestrant: 500 mg Q4W, intramuscular use

Primary Outcome Measure

Occurrence of adverse events (AEs)- Part 1 [ Time Frame: Up to follow-up period, approximately 24 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteCommackNew York11725-
Research SiteHarrisonNew York10604-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteUniondaleNew York11553-
Research SiteChapel HillNorth Carolina27514-
Research SiteChattanoogaTennessee37404-
Research SiteGermantownTennessee38138-
Research SiteFort WorthTexas76104-

Find similar trials in Commack, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Commack, NYResearch Site· Harrison, NYResearch Site· New York, NYResearch Site· Uniondale, NYResearch Site· Chapel Hill, NCResearch Site· Chattanooga, TN

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