Phase II study of PF-04691502 and Letrozole in breast cancer

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, RANDOMISED PHASE 1B/2 STUDY OF PF-04691502 IN COMBINATION WITH LETROZOLE COMPARED WITH LETROZOLE ALONE IN PATIENTS WITH ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE EARLY BREAST CANCER

• IRAS ID

  100434

• Contact name

  Stephen Johnston

• Sponsor organisation

  Pfizer Inc 235 East and 24nd Street, New York, NY10017

• Eudract number

  2011-003044-53

• ISRCTN Number

  xx

• Research summary

  In women with oestrogen receptor-positive cancers, cancer cell growth is under the control of oestrogen. Therefore, such cancers are often susceptible to treatment with an endocrine therapy. , The available endocrine therapies work by inhibiting the synthesis of oestrogen or blocking the interaction between oestrogen and the oestrogen receptor. Sixty % to 70% of all breast cancers are oestrogen receptor-positive. Only approximately 60% of these cancers respond optimally to endocrine therapy and so a new way of treatment is being looked into. A new investigational drug, called PF-04691502 is being developed by Pfizer to see if there are better results when used alongside Letrozole which is a standard treatment for these tumours . PF-04691502 might diminish or delay the inherent or acquired resistance to endocrine therapy in the tumour and restore hormone sensitivity in this high risk patient population, allowing the Letrozole to work better. Participants will receive just Letrozole, or both PF-04691502 and Letrozole together, or just PF-04691502 for 2 weeks. Participants will receive another 4 weeks of treatment but those receiving just PF-04691502 will receive both PF-04691502 and Letrozole together. Participation is s on a voluntary basis and in agreement with their doctors, participants may go on with the treatment for an additional 10 weeks until the surgery of their tumours. Evaluations on the growth of the tumour will be done to see which treatment works better. The study will also look at how PF-04691502 works inside the tumour. PF-04691502 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. Letrozole (Femara©) is a drug approved in the EU and is available by prescription for the treatment of postmenopausal women with hormone receptor-positive early stage or advanced stage breast cancer. This study is multicentre, which means it will take place in several countries around the world and is looking to recruit about 204 patients in all. Patients will be randomised to either treatment arm, which means that they will be randomly assigned to receive one of the treatments reported above.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1010

• Date of REC Opinion

  11 Sep 2012

• REC opinion

  Further Information Favourable Opinion