AZD8931 In Combination With Anastrozole in Endocrine Naive ABC

• Research type

  Research Study

• Full title

  A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination with Anastrozole, Compared to Anastrozole alone, in Post-menopausal Women With Hormone Receptor-positive, Endocrine Therapy-naive, Locally-advanced or Metastatic Breast Cancer (MINT)

• IRAS ID

  26954

• Contact name

  Stephen RD Johnston

• Sponsor organisation

  Astra Zeneca UK

• Eudract number

  2009-012934-63

• ISRCTN Number

  N/A

• 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. This study will assess how safe and effective AZD8931 is when given in combination with anastrozole compared to anastrozole alone. Patients in the study will be post-menopausal females who have localised or breast cancer that has spread beyond the breast. Patient with breast cancer that are known to expresses high levels of a protein called HER2 will be excluded from the study because there are a number of current treatments available for cancers that express high levels of HER2. The patients cancer will also need to express either oestrogen or progesterone receptors (ER or PgR). The expression of ER and PgR makes patients suitable for treatment with anastrozole. The patients must not have received any prior treatments with drugs like tamoxifen or anastrozole (known as endocrine treatments). Once screened, patients will be allocated, by chance, to treatment with AZD8931 at one of two different doses or placebo (a dummy pill) (1:1:1) in combination with anastrozole. Anastrozole is a standard treatment for patients with post-menopausal breast cancer. Participants will receive treatment in this study until their cancer gets worse or until they or their study doctor feels it is in their best interests to stop. Once treatment has stopped patients treated according to normal clinical practise and will be followed for survival status.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/46

• Date of REC Opinion

  14 Oct 2009

• REC opinion

  Further Information Favourable Opinion