WHO ICTRP trial
Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus…
EUCTR2008-000709-12-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2008-000709-12-FR |
|---|---|
| Public title | Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naïve Patients With HER2-Positive Breast Cancer |
| Scientific title | Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naïve Patients With HER2-Positive Breast Cancer |
| Primary sponsor | Cephalon France |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Spain;Belgium;Austria;Netherlands;Italy;United Kingdom |
| Conditions | Patients with human epidermal growth factor receptor-2 (HER2) positive stage II or III breast cancer MedDRA version: 9.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer |
| Interventions | Trade Name: MYOCET Pharmaceutical Form: Powder for concentrate for solution for infusion Current Sponsor code: CEP-19562 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Cyclophosphamide 1… |
| Registration date | Jan 4, 2008 |
| Target size | 120 |
| Secondary IDs | C19562/2037/BC/EU |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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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: