At a glance
ClinicalIndex Comparison Record- ✓Pathologically documented breast cancer that is unresectable and/or metastatic
- ✓HER2-low status (IHC 1+ or IHC 2+/ISH-) or HER2 IHC 0 per ASCO CAP 2018 guidelines
- ✓Never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology
- ✓Never previously treated with anti-HER2 therapy in metastatic setting
- ✕Prior treatment with antibody drug conjugate (ADC)
- ✕Uncontrolled or significant cardiovascular disease
- ✕Corrected QT interval prolongation
- ✕History of interstitial lung disease (ILD)/pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)
In Brief
A Phase 3 clinical trial evaluating Trastuzumab Deruxtecan for Breast Cancer. Currently recruiting, targeting 250 participants across 88 sites in 10 countries.
Detailed Summary
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Study Details
Timeline
Arms & Interventions
Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd. Participants must also have recurrent disease \<2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.
Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Interventions
Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug