IMCL CP12-0606/TRIO-012 version 4.0 18 July 2008
Research type
Research Study
Full title
A Multicenter, Multinational, Randomized, double-blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative,Unresectable, Locally-Recurrent or Metastatic Breast Cancer.
IRAS ID
19336
Contact name
andrew wardley
Sponsor organisation
Imclone Systems (ImClone LLC)
Eudract number
2008-001727-65
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical trial is to see how effective and safe is combining the experimental medication IMC-1121B with docetaxel (a standard chemotherapy) as compared to treating a breast cancer with docetaxel alone. IMC-1121B is not yet approved by any regulatory authority but has shown to prevent the growth of new blood vessels and thereby shrink tumours. Patients, with breast cancer that has spread to a different part of the body (metastases) or that has locally relapsed and cannot be removed surgically, will receive, by chance, either docetaxel and IMC-1121B or docetaxel and placebo, until progression of the tumour or unacceptable treatment toxicity. Participants and doctors are blind to who receive IMC-1121B or placebo. Docetaxel, IMC-1121B and placebo will be administered intravenously, each over one hour, every 3 weeks. The study treatment will last approximately 6 months but may be shorter or longer depending how the patient does on the study. During this period, physical examination and blood analyse will be performed before each study treatment infusion, scan assessment and urine analysis will be done every 6 weeks, and a Quality of Life Questionnaire will have to be completed every 12 weeks. After completing the study treatment, the patient's health status will be followed up by the study staff at least 36 months. In addition, this study also aims to develop tests that will help in the investigation of cancer and that may help to understand why some patients may be more sensitive to the drugs than others. These are developed by studying blood and tissue from tumours. Therefore patients will be requested to provide blood and tumour samples for analyzing. This study is sponsored by ImClone Systems Corporation, a for profit drug company, that manufactures IMC-1121B. This study will be conducted in about 230 institutions worldwide and will enroll 1113 women.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
09/H0402/74
Date of REC Opinion
5 Aug 2009
REC opinion
Further Information Favourable Opinion