WHO ICTRP trial
Assesment of response predictor genes in patients with initial breast cancer…
EUCTR2013-001036-22-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2013-001036-22-ES |
|---|---|
| Public title | Assesment of response predictor genes in patients with initial breast cancer HER2+ to the lapatinib and trastuzumab treatment combination before surgery. |
| Scientific title | PAM50 HER2-enriched phenotype as a predictor of early response to neoadjuvant lapatinib plus trastuzumab in Stage I to IIIA HER2-positive breast cancer - PAMELA |
| Primary sponsor | SOLTI |
| 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 | Spain;Austria |
| Conditions | Untreated invasive breast carcinoma eligible for primary definitive surgery (Stage I-IIIA) MedDRA version: 14.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign… |
| Interventions | Trade Name: Tyverb Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lapatinib Other descriptive name: LAPATINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Trade Name: Letrozol… |
| Registration date | Dec 7, 2013 |
| Target size | 0 |
| Secondary IDs | SOLTI-1114 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: