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

Conditions

• Breast Cancer; HER2-positive; Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan — DRUG
  Administered by intravenous infusion
• Placebo — DRUG
  Administered by intravenous infusion
• Taxane — DRUG
  Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
• Pertuzumab — DRUG
  Administered by intravenous infusion
• Trastuzumab — DRUG
  Administered by intravenous infusion

Study Details

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.

Key Dates

Start date

Apr 26, 2021

Status verified

May 2026

Primary completion

Jul 6, 2026

Completion

Dec 30, 2029

Study Design

Enrollment

1,157 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo
• Experimental: Arm B
  Trastuzumab deruxtecan (T-DXd) plus pertuzumab
• Active Comparator: Arm C
  Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment [ Time Frame: Until progression or death, assessed up to approximately 60 months ]

Locations (30)

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