Neratinib vs lapatinib + capecitabine in locally advanced or MBC
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer.
IRAS ID
15146
Contact name
Anne Rigg
Sponsor organisation
PUMA Biotechnology Inc.
Eudract number
2008-005425-11
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This research study will involve subjects with either locally advanced or metastatic breast cancer (MBC). Among women with breast cancer, 40 to 50% will develop metastatic disease, meaning that the breast cancer cells have travelled from the breast to another part of the body. Cancer cells travel through either the lymphatic system or the blood vessels. As there is no cure for MBC, current therapy is palliative (it aims to reduce the severity of a disease or slows its progress rather than providing a cure).The main purpose of this study is to compare the progression-free survival of subjects taking the experimental drug HKI-272 (neratinib) as a single agent versus that of subjects taking a combination of lapatinib plus capecitabine. All three drugs are taken in tablet form: Neratinib once a day, Lapatinib once a day and capecitabine twice a day.Safety, pharmacokinetic (what the body does to the drug) and quality of life data will be obtained, and markers of efficacy will be assessed. Safety parameters assessed will include physical examinations, medical history, vital signs, ECGs, heart function tests and laboratory evaluations. Clinical activity will be assessed by performing tumour assessments (scans) periodically throughout the study.Subjects will sign an informed consent form before any tests or examinations are done and before any questions are asked. Each subject??s suitability for the study will be assessed during a screening visit. The treatment period will run to up to 16 cycles of treatment, each cycle lasting 21 days. The survival status of subjects who permanently discontinue study medication will be followed up.
REC name
London - London Bridge Research Ethics Committee
REC reference
09/H0804/64
Date of REC Opinion
24 Jul 2009
REC opinion
Further Information Favourable Opinion