OncoMatch/Clinical Trials/NCT07205822
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
Official title: A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)
Is NCT07205822 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Dato-DXd for breast cancer.
Treatment: Dato-DXd — A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≥1%)
HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%])
Required: PR (PGR) expression (≥1%)
HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%])
Required: HER2 (ERBB2) wild-type (IHC 0)
HER2 IHC 0 (defined as including HER2 null with no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: endocrine therapy
Progressed on and not suitable for further endocrine therapy per investigator assessment.
Cannot have received: TROP2-targeted therapy
Any TROP2-targeted therapy.
Cannot have received: topoisomerase I inhibitor (including ADCs)
Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I.
Cannot have received: chemotherapy in the metastatic setting
Any chemotherapy in the metastatic setting.
Cannot have received: curative radiotherapy
Exception: palliative radiotherapy for optimal symptom control or pain management is allowed
Curative radiotherapy; however, palliative radiotherapy for optimal symptom control or pain management is allowed.
Lab requirements
Blood counts
Haemoglobin ≥ 9.0 g/dL (no transfusion within 1 week prior to screening). Absolute neutrophil count ≥ 1.5×10^9/L (no G-CSF within 1 week prior to screening). Platelet count ≥ 100×10^9/L (no platelet transfusion within 1 week prior to screening). Serum albumin ≥ 2.5 g/dL.
Kidney function
Calculated CrCL ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight).
Liver function
TBL ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinaemia). ALT and AST ≤ 2.5 × ULN; for participants with hepatic metastases, ALT and AST ≤ 5 × ULN.
Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Largo, Florida
- Research Site · Fort Wayne, Indiana
- Research Site · Omaha, Nebraska
- Research Site · New York, New York
- Research Site · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07205822 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior endocrine therapy, TROP2-targeted therapy, topoisomerase I inhibitor (including ADCs) disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify