OncoMatch/Clinical Trials/NCT06533826
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Is NCT06533826 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab Deruxtecan and Datopotamab Deruxtecan for breast cancer.
Treatment: Trastuzumab Deruxtecan · Datopotamab Deruxtecan — The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer. The names of the study drugs involved in this study are: * Datopotamab deruxtecan (a type of antibody drug conjugate) * Trastuzumab deruxtecan (a type of antibody drug conjugate)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) IHC 1+ or 2+/ISH- (HER2-low) (IHC 1+ or 2+/ISH-)
HER2-low status is defined as IHC 1+ or 2+/ISH non-amplified breast cancer in any prior tumor sample
Required: HER2 (ERBB2) IHC 0+/ISH- or IHC 0+/ISH untested (HER2-0) (IHC 0+ (null or ultra-low))
HER2-0 status is defined as IHC 0 (null or ultra-low) in all prior tumor samples with available HER2 pathology results: IHC 0+/ISH- or IHC 0+/ISH untested
Required: HER2 (ERBB2) no known HER2 IHC 3+ or ISH-amplified breast cancer (must not be HER2-positive)
no known history of HER2-positive breast cancer. All available prior HER2 pathology results must be HER2-low or HER2-0; no known HER2 IHC 3+ or ISH-amplified breast cancer is allowed.
Allowed: ESR1 expression ≥1%
HR-positive cohorts: ER and/or PR expression ≥1%
Allowed: PR (PGR) expression ≥1%
HR-positive cohorts: ER and/or PR expression ≥1%
Allowed: ESR1 expression <1%
HR-negative cohorts: ER and PR expression <1%
Allowed: PR (PGR) expression <1%
HR-negative cohorts: ER and PR expression <1%
Disease stage
Metastatic disease required
unresectable locally advanced or metastatic disease; measurable disease per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — adjuvant or metastatic
Participants with HR-positive breast cancer considered to be candidates for endocrine therapy must have: a) progressed on or within 12 months of adjuvant endocrine therapy or received at least one line of endocrine therapy in the metastatic setting, and b) received prior CDK4/6 inhibitor.
Must have received: CDK4/6 inhibitor
received prior CDK4/6 inhibitor
Cannot have received: topoisomerase I inhibitor
Exception: allowed as specified for ADC2 cohorts
Prior topoisomerase I inhibitor therapy is not allowed in any setting, except as specified below for ADC2 cohorts.
Lab requirements
Blood counts
Absolute neutrophil count ≥1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dl; INR/PT/aPTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy and PT or aPTT is in therapeutic range of anticoagulant
Kidney function
Serum or plasma creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 30 mL/min/1.73m2 for participants with creatinine levels above institutional ULN
Liver function
Total bilirubin ≤ 1.5 × ULN (or ≤ 3.0 x ULN in patients with Gilbert's Syndrome); AST(SGOT)/ALT(SGPT) ≤ 2.5 × ULN or ≤ 5.0 × ULN for participants with documented liver metastases
Cardiac function
For T-DXd cohorts, baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or MUGA scan if echocardiogram cannot be performed or is inconclusive)
Participants must have adequate organ and marrow function within 2 weeks prior to study treatment initiation as defined below: ... For T-DXd cohorts, baseline LVEF ≥ 50% prior to registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama · Birmingham, Alabama
- University of San Francisco · San Francisco, California
- Yale University Cancer Center · New Haven, Connecticut
- Georgetown University Medical Center · Washington D.C., District of Columbia
- University of Chicago Medical Center · Chicago, Illinois
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