West Cancer Center

BREAST: METASTATIC: HER2+:1ST LINE: DESTINY BREAST-09

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)

Title

AstraZeneca D967UC00001 DESTINY BREAST-09 (HER2+)

Study 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)

Site Link

NCT04784715

Malignancy

Breast cancer, IBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab Deruxtecan

Drug Class

Anti-body drug conjugate against HER2

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Advanced or metastatic breast cancer that is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) with known horme receptor status
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.
No more than 1 previous line of endorcrine therapy in the metastatic setting
Adjuvant/neo-adjuvant therapy allowed if >6 months from treatment to metastatic diagnosis
ECOG PS 0-1
No clinically active CNS disease
No active ILD/pneumonitis

Objective

Primary Endpoint
- PFS (blinded review)
Secondary Endpoints
- PFS (Investigator Review)
- OS
- ORR
- DoR
- PFS2
- PROs
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2+ (IHC 3+ or FISH+)

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes