Breast cancer (metastatic hormone-receptor) - lapatinib and trastuzumab (with aromatase inhibitor) [ID344]

Lapatinib and trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor positive breast cancer which over-expresses HER2

Status: History
Expected date of issue: June 2012
Referral date: October 2008
Process: MTA

NICE published guidance: Breast cancer (metastatic hormone-receptor) - lapatinib and trastuzumab (with aromatase inhibitor) (TA257) June 2012

Topic area:

NICE project team

Executive Lead: TBC
Technical Lead: Sally Doss
Communications manager: Paul Cooney
Project manager: Bijal Joshi


Provisional schedule

Consultation on draft scope by stakeholders: 9 December 2009
Information meeting with consultees: TBC
Closing date for invited submissions / evidence submission: 7 June 2010
1st appraisal committee meeting: 17 November 2010
2nd appraisal committee meeting: 16 February 2011
3rd appraisal committee meeting: 18 May 2011
4th appraisal committee meeting: 17 January 2012
5th appraisal committee meeting: 15 March 2012


Consultees and commentators

Consultees Commentators (no right to submit or appeal)


  • GlaxoSmithKline (lapatinib)
  • Roche Products (trastuzumab)

Patient/carer groups

  • Afiya Trust
  • Black Health Agency
  • Breakthrough Breast Cancer
  • Breast Cancer Campaign
  • Breast Cancer Care
  • Breast Cancer Haven
  • Breast Cancer UK
  • CANCERactive
  • Cancer Black Care
  • Cancer Equality
  • Chinese National Healthy Living Centre
  • Counsel and Care
  • Equalities National Council
  • Helen Rollason Heal Cancer Charity
  • Macmillan Cancer Support
  • Maggie’s Centres
  • Marie Curie Cancer Care
  • Muslim Council of Great Britain
  • Muslim Health Network
  • National Cancer Alliance
  • National Council for Palliative Care
  • South Asian Health Foundation
  • Specialised Healthcare Alliance
  • Sue Ryder Care
  • Tenovus
  • Women’s Health Concern

Professional groups

  • Association of Cancer Physicians
  • British Association for Services to the Elderly
  • British Geriatrics Society
  • British Institute of Radiology
  • British Oncological Association
  • British Psychosocial Oncology Society
  • Cancer Networks Pharmacists Forum
  • Cancer Research UK
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians, Medical Oncology Joint Special Committee
  • Royal College of Radiologists
  • Royal Society of Medicine – Intellectual Disabilities Forum
  • United Kingdom Clinical Pharmacy Association
  • United Kingdom Oncology Nursing Society


  • Conwy LHB
  • Department of Health
  • Portsmouth City Teaching PCT
  • Welsh Assembly Government


  • Board of Community Health Councils in Wales
  • British National Formulary
  • Commissioning Support Appraisals Unit
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Medicines and Healthcare products Regulatory Agency
  • National Association for Primary Care
  • National Public Health Service for Wales
  • NHS Alliance
  • NHS Confederation
  • NHS Purchasing and Supply Agency
  • NHS Quality Improvement Scotland
  • Scottish Medicines Consortium

Comparator manufacturers

  • AstraZeneca (anastrozole)
  • Novartis Pharmaceuticals (letrozole)
  • Pfizer (exemestane)

Relevant research groups

  • Against Breast Cancer
  • Breast Cancer Hope
  • Breast Cancer Research Trust
  • Cochrane Collaboration – Cochrane Breast Cancer Group
  • Institute of Cancer Research
  • MRC Clinical Trials Unit
  • National Cancer Research Institute
  • National Cancer Research Network
  • National Institute for Health Research
  • Policy Research Institute on Ageing and Ethnicity
  • Pro-Cancer Research Fund
  • Research Institute for the Care of Older People

Assessment Group

  • Liverpool Reviews & Implementation Group, University of Liverpool
  • National Institute for Health Research Health Technology Assessment Programme

Associated Guideline Groups

  • National Collaborating Centre for Cancer

Associated Public Health Groups

  • tbc



Project history





1 November 2011


The Appeal Panel met on 08 September 2011 to consider the appeal lodged by Roche against the Final Appraisal Determination (FAD) for this appraisal.  The decision of the appeal panel has been received.

The Appeal Panel concludes that it upholds the appeal on the grounds that the Institute has failed to act fairly in relation to point 1.1 and has formulated guidance which cannot be reasonably justified in the light of the evidence submitted in relation to points 2.1 and 2.3.  The appeal is dismissed on all other grounds.

The FAD will be referred back to the Appraisal Committee for discussion on 17 January 2012, after which a further consultation document will be produced. Therefore the second Appraisal Committee discussion will take place on 15 March 2012. Following this meeting, the committee will produce a second FAD.  




Key documents

This page was last updated: 24 December 2013

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.