LANTERN

• Research type

  Research Study

• Full title

  A randomised phase II screening trial with functional imaging and patient reported toxicity sub-studies comparing LApatiNib plus capecitabine versus continued Trastuzumab plus capecitabine after local therapy in patients with ERb B2 positive metastatic breast cancer developing braiN metastasis /es

• IRAS ID

  62189

• Contact name

  David Dodwell

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2010-022737-28

• ISRCTN Number

  n/a

• Research summary

  Study Design: LANTERN is a randomised, phase II, multi-centre, prospective, controlled, open label, parallel group screening trial in patients with advanced ErbB2-positive metastatic breast cancer and newly diagnosed brain metastases pre-treated with trastuzumab with equal randomisation comparing lapatinib in combination with capecitabine versus continued trastuzumab in combination with capecitabine after local therapy (WBRT) / Stereotatic Radio surgery (SRS)). Trial End Points: Primary Endpoint: Time to progression of central nervous system (CNS) metastases. Secondary Endpoints: Progression-free survival, Overall survival, CNS overall response rate, CNS clinical benefit response rate, Total days of steroid use for palliation of CNS symptoms, Neurological quality of life, Delay/stabilisation of CNS symptoms, Qualitative and quantitative toxicities, Feasibility of recruitment into a phase III trial. Sub-studies: Two sub-studies will also be performed. The functional imaging sub-study will investigate the relationship between blood brain barrier permeability and response to treatment, whilst the patient-reported toxicity sub-study will assess the method and outcome of patient-reported toxicity. Proposed Period of Recruitment and Follow. Up: We will recruit 130 patients, who will be randomised on an equal basis to lapatinib plus capecitabine or trastuzumab plus capecitabine. Randomisation will take place from 12-15 centres over 24 months. The trial follow-up period is 6 months.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/81

• Date of REC Opinion

  21 Dec 2010

• REC opinion

  Further Information Favourable Opinion