WHO ICTRP trial

Treatment with olaparib in patients with breast cancer

EUCTR2017-001054-34-GB · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2017-001054-34-GB
Public title Treatment with olaparib in patients with breast cancer
Scientific title LUCY - Lynparza Breast Cancer Real World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients with Germline or Somatic BRCA1/2 Mutations - LUCY
Primary sponsor AstraZeneca AB
Registry EU Clinical Trials Register
Recruitment status Authorised
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 United States;Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Bulgaria;Germany;China;Japan;Korea, Republic of
Conditions Metastatic Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C]…
Interventions Product Name: olaparib 100 mg Product Code: AZD2281 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: olaparib CAS Number: 763113-22-0 Current Sponsor code: AZD2281 Concentration unit: mg milligram(s) Concentration type: equal…
Registration date Sep 28, 2017
Target size 270
Secondary IDs D0816C00018;NCT03286842
Registry page clinicaltrialsregister.eu

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