Temsirolimus and Neratinib in patients with breast cancer - Amdt 10

• Research type

  Research Study

• Full title

  A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients with Metastatic HER2-Amplified or Triple-Negative Breast Cancer

• IRAS ID

  132858

• Contact name

  Stephen Johnston

• Contact email

  stephen.johnston@rmh.nhs.uk

• Sponsor organisation

  Puma Biotechnology, Inc.

• Eudract number

  2012-005037-37

• Clinicaltrials.gov Identifier

  NCT01111825

• Research summary

  This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to
  determine the MTD of temsirolimus with daily neratinib, and to determine the safety and efficacy of this
  combination when given to patients with advanced breast carcinoma. Patients with trastuzumab-refractory HER2-
  amplified disease or triple-negative disease will be enrolled.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  13/LO/1253

• Date of REC Opinion

  2 Oct 2013

• REC opinion

  Further Information Favourable Opinion