WHO ICTRP trial
Study to assess the efficacy and safety of alpelisib (BYL719) in combination…
CTIS2024-512050-13-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2024-512050-13-00 |
|---|---|
| Public title | Study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation |
| Scientific title | EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA… |
| Primary sponsor | Novartis Pharma AG |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not 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 | China;Malaysia;France |
| Conditions | HER2-positive advanced breast cancer MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2 MedDRA version: 21.1Level: LLTClassification code… |
| Interventions | Product Name: ALPELISIB, Product Code:SUB180707, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: , Strength: , Product Name: ALPELISIB, Product Code:SUB180707, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive… |
| Registration date | Jun 25, 2024 |
| Target size | 4 |
| Secondary IDs | NCT04208178;2019-002741-37 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: