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BREAST: METASTATIC: HER2 low (IHC 1+, 2+): DESTINY-BREAST08

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Title
Astra Zeneca D967JC00002 Breast HER2 low DESTINY-Breast08
Study Title

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Site Link
Malignancy
Breast Cancer, IDC, ILC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st, 2nd, or 3rd depending on bucket
Investigational Agent
trastuzumab deruxtecan (T-DXd). Various arms contain durvalumab, paclitaxel, capivasertib, anastrozole, fulvestrant, and capectabine
Drug Class
HER2 antibody drug conjugate
PI
Greg Vidal, MD, PhD
Sponsor
AstraZeneca
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Breast cancer with history of HER2-low expression, defined as IHC2+/ISH negative or IHC1+ with a validated assay
  • May be either hormone receptor positive or negative
  • ECOG PS 0-1
  • If hormone receptor positive disease
    • Part 1: Must have had at least 1 prior treatment line of endocrine therapy with or without a targeted therapy (CDK4/6, mTOR, or PI3K) and at least one prior line of chemotherapy, all for metastatic disease
    • Part 2: Only 1 prior treatment line of ET with or without a targeted therapy. No prior chemothearpy for MBC
  • If hormone receptor negative disease
    • Part 1: At least 1 prior line of chemotherapy for MBC
    • Part 2: For Module 2, no prior lines of thearpy for MBC. For Modules 1 and 3, only 1 prior line fo chemotherapy for MBC
  • No significant cardiovascular disease
  • No history of pneumonitis requiring steroids
    • No clinically active CNS metastatses or spinal cord compression
Objective
  • Primary Objective
    • Safety
  • Secondary objectives:
    • ORR
    • PFS
    • DoR
    • OS
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
HER2 IHC 1+ or IHC2+ with negative ISH
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X