AZD8931+Paclitaxel in advanced breast cancer with low Her2 expression
Research type
Research Study
Full title
A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumours and in a selected population with Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)
IRAS ID
18095
Contact name
Robert Charles Swanton
Sponsor organisation
AstraZeneca
Eudract number
2009-010551-26
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This study will evaluate a new drug, AZD8931, which is being tested for the treatment of cancer. AZD8931 acts by blocking the activity of proteins which may be responsible for the growth and survival of cancer cells. AZD8931??s ability to block the action of these proteins may stop the cancer cells growing and assist chemotherapy to kill the cancer cells. This study will be in two parts. The first part (phase I) will identify the highest dose of AZD8931 that may be safely combined with a chemotherapy called paclitaxel. (the UK will not be involved in this part) The dose decided in part 1 will then be used in part 2 of the study. The second part of the study (phase II) will assess how safe and effective AZD8931 is when given in combination with paclitaxel compared to paclitaxel alone. Participants in the second part of the study will have breast cancer that has spread beyond the breast and/or recurred following surgery to remove it. The breast cancer will need to express low levels of a specific protein called HER-2 but patients must be unsuitable for the standard HER-2 acting treatments currently available. Before being enrolled into the study the cancers of potential participants will be tested to ascertain if they express low levels of the HER-2 protein that AZD8931 acts on. If they do, participants will be allocated, by chance, treatment with AZD8931 or placebo (a dummy pill) (1:1) in combination with paclitaxel chemotherapy. Paclitaxel is a normal treatment for patients with breast cancer. Participants will receive treatment in this study until their cancer progresses or until they or their study doctor feels it is their best interest to stop.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
09/H0206/40
Date of REC Opinion
10 Aug 2009
REC opinion
Further Information Favourable Opinion