Phase Ib/II study of AUY922 + Trastuzumab in HER2+ breast cancer

• Research type

  Research Study

• Full title

  A Phase Ib/II, multi enter, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one trastuzumab-containing regimen

• IRAS ID

  51699

• Contact name

  Karla Martins

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-015628-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Phase Ib/II study. The goal of the Phase Ib study is to establish a safe dose range based on side effects of AUY922 the study drug. The goal of the Phase II will evaluate how well the study drug combination might work in treating advanced or metastatic breast cancer (MBC).The medicine being tested in this study is AUY922 a new type of drug which interferes with the folding of proteins in cancer cells and causes them to die. Trastuzumab (Herceptin©) - The other study drug trastuzumab is a medicine already approved for the treatment of various cancers, and is already widely used worldwide to treat patients with advanced or metastatic breast cancer. Both AUY922 and trastuzumab, will be given intravenously, once a week. Trastuzumab will always be administered before AUY922. AUY922 and trastuzumab have different modes of action on tumour cells, by combining them, it might be possible to slow the progression of the disease rather than if each treatment was given separately. So far, AUY922 has been tested extensively in the laboratory but has also been tested in more than 100 patients with various cancers whose disease has not been controlled by available therapies. Participants in the study will attend clinic visits twice a week in the first 21 day cycle and once a week for all subsequent cycles. Study procedures include Chest X ray, Eye exams, CT/MRI scans, PET Imaging, Cardiac scan, ECG's and blood tests. Approximately 52 patients (only women) with locally advanced or metastatic breast cancer will join in this study (about 12 patients will participate in the Phase Ib of the study and about 40 patients will participate in the Phase II).This trial is sponsored by the pharmaceutical company named Novartis.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/78

• Date of REC Opinion

  20 Sep 2010

• REC opinion

  Further Information Favourable Opinion