WHO ICTRP trial
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan…
CTIS2025-520582-51-00 · EU Clinical Trials Information System · Recruiting
Key facts
| Trial ID | CTIS2025-520582-51-00 |
|---|---|
| Public title | An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04) |
| Scientific title | An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04) - MK-1022-016 |
| Primary sponsor | Merck Sharp & Dohme LLC |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | Argentina;Korea, Republic of;Chile;Japan;Peru;Vietnam;Canada;Colombia;Thailand;Turkey;Taiwan;United Kingdom;Israel;Brazil;United… |
| Conditions | Hormone receptor positive breast cancer MedDRA version: 28.0Level: PTClassification code: 10085481Term: Hormone receptor positive HER2 negative breast cancer Class: 100000004864 MedDRA version: 23.0Level: PTClassification code… |
| Interventions | Product Name: , Product Code:SCP129816, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: PACLITAXEL ALBUMIN-BOUND, Product Code:SUB127678, Pharmaceutical Form: POWDER FOR DISPERSION FOR INFUSION, Other descriptive… |
| Registration date | Oct 6, 2025 |
| Target size | 1000 |
| Secondary IDs | U1111-1317-5490;171605 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: