AZD5363 in patients with advanced or metastatic breast cancer (BEECH)

• Research type

  Research Study

• Full title

  A Phase I/II, Multicentre, Study Comprising a Safety Run-In of AZD5363 when Combined with Paclitaxel in Patients with Advanced or Metastatic Breast Cancer; Followed by a Randomised Expansion of AZD5363 when Combined with Paclitaxel vs. Paclitaxel plus Placebo in Patients with ER-Positive Advanced or Metastatic Breast Cancer, Stratified by PIK3CA Mutation Status (BEECH)

• IRAS ID

  99497

• Contact name

  Nicholas Turner

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-006312-31

• ISRCTN Number

  n/a

• Research summary

  AstraZeneca is conducting a research study with AZD5363, a new anticancer agent, in patients with advanced breast cancer. Laboratory studies have shown that AZD5363 helps to reduce the growth of some cancer cells and increases sensitivity of some cancer cells to the chemotherapy drug paclitaxel. Patients may benefit from participating in the study but there is no guarantee. This study comprises two parts (A and B). Part A is designed to investigate the safety and tolerability of AZD5363, given as continuous or intermittent dose schedules, in combination with paclitaxel. Part A will identify a dose and schedule of AZD5363 for use in Part B. Part B is designed to investigate the anti-tumour activity of AZD5363, in the dose and schedule selected from Part A, compared with placebo, when in combination with paclitaxel. Part B patients must not have received prior chemotherapy for advanced breast cancer and their tumour must be estrogen receptor positive. Before study treatment begins, patients will have their tumour tested for mutations of phosphoinositide 3-kinase (PIK3CA), to see if this sub-group of patients is more responsive to AZD5363. The study will assess the safety and tolerability of AZD5363, the tumour response and how the body handles the study treatments (e.g. absorption and removal of AZD5363 and paclitaxel). The study will also measure various biomarkers (substances that help to measure or predict progress of disease or the effect of treatment) and will look at how genes (the building blocks of cells) affect the response to the drug. Patients will be recruited from approximately 12 clinics, internationally. After giving consent to take part, patients will attend frequent hospital visits throughout the study. At each visit, assessments will be made to check the patient??s health and see how the drug is working. Patients may remain on drug for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0803

• Date of REC Opinion

  20 Jul 2012

• REC opinion

  Further Information Favourable Opinion