PENELOPE-B

• Research type

  Research Study

• Full title

  Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 inhibitor, in patients with hormone-receptor positive, HER2 normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy (PENELOPE-B trial).

• IRAS ID

  164571

• Contact name

  Laura Stevenson

• Contact email

  penelopeb-icrctsu@icr.ac.uk

• Sponsor organisation

  GBG Forschungs GmbH

• Eudract number

  2013-001040-62

• Clinicaltrials.gov Identifier

  NCT01864746

• Duration of Study in the UK

  5 years, 0 months, 31 days

• Research summary

  PENELOPE-B will evaluate whether adding a new drug called palbociclib to standard hormone therapy is better than using standard hormone therapy alone for the treatment of breast cancer patients with an increased risk of their cancer returning, known as relapse, after having received chemotherapy prior surgery.

  Women with 'luminal type' early breast cancer who have received treatment with chemotherapy prior to recent surgery but who have been identified as having a high risk of relapse will be invited to join the PENELOPE-B study. Luminal type breast cancer is defined as breast cancer whose cells have more than normal amounts of hormone receptors (HR) but normal amounts of HER2 receptors on their surface (HR positive and HER2 normal or 'negative').

  Patients will be randomised to one of two treatment groups:
  Group A: Standard hormone therapy + palbociclib for 52 weeks
  Group B: Standard hormone therapy + placebo for 52 weeks

  After the 52 week trial treatment period all patients will continue to receive standard hormone therapy for a total period of at least 5 years.

  PENELOPE-B is sponsored by GBG Forschungs GmbH (GBG) an academic research institution who specialise in conducting clinical trials in breast cancer and are based in Germany. Within the UK the study is being coordinated by The Institute of Cancer Research Clinical Trials & Statistics Unit (ICR-CTSU).

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  16/LO/0459

• Date of REC Opinion

  30 Mar 2016

• REC opinion

  Favourable Opinion