NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial
A Phase 2 Trial of neoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan (HER3-DXd; U3-1402) With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial
Sponsor: SOLTI Breast Cancer Research Group + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Rate of pCRBL (ypT0/is ypN0) at surgery
Time frame: before treatment and surgery
Secondary Endpoints
Rate of Residual cancer burden (RCB) category status (0, I, II, III)
pCRB (pathological complete response in the breast)
Tumor overall objective response rate (ORR)
Eligibility Criteria
Main inclusion criteria 1. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed 2. ER-positive and/or PgR-positive and HER2-negative tumor 3. Ki67% ≥ 20% locally assessed and/or high genomic risk (defined by gene signature): 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Breast cancer eligible for primary surgery. 6. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis. 7. Participants must be deemed eligible for neoadjuvant chemotherapy 8. Participants must be deemed eligible for surgery. 9. Adequate hematologic and end-organ function, defined by the following laboratory results 10. Baseline LVEF ≥ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan Main exclusion criteria 1. Metastatic (Stage IV) breast cancer. 2. Bilateral invasive breast cancer. 3. Any treatment, local or systemic, includi…
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