Advanced breast cancer:

chemotherapy and
biological therapy
A NICE pathway brings together all NICE guidance, quality
standards and materials to support implementation on a specific
topic area. The pathways are interactive and designed to be used
online. This pdf version gives you a single pathway diagram and
uses numbering to link the boxes in the diagram to the associated
recommendations.
To view the online version of this pathway visit:
http://pathways.nice.org.uk/pathways/advanced-breast-cancer
Pathway last updated: 22 June 2015. To see details of any updates to this pathway since its launch,
visit: About this Pathway. For information on the NICE guidance used to create this path, see:
Sources.
Copyright NICE 2015. All rights reserved

NICEPathways
Pathways

Advanced breast cancer: chemotherapy and biological therapy

Advanced breast cancer pathway

Copyright NICE 2015.

NICE Pathways

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Advanced breast cancer: chemotherapy and biological therapy

NICE Pathways

Chemotherapy for patients with advanced breast cancer

No additional information

Treatment with anthracyclines

No additional information

Disease progression

No additional information

Anthracyclines contraindicated or not suitable

No additional information

Sequential systemic therapy

On disease progression, offer systemic sequential therapy to the majority of patients with
advanced breast cancer who have decided to be treated with chemotherapy.
Consider combination therapy for patients for whom a greater probability of response is
important, and who understand, and are likely to tolerate, the additional toxicity.

Tumour overexpresses HER2?

No additional information

First-line therapy

For patients with advanced breast cancer who are not suitable for anthracyclines (because they
are contraindicated or because of prior anthracycline treatment either in the adjuvant or
metastatic setting), offer single-agent docetaxel as first-line therapy.

Advanced breast cancer pathway

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Advanced breast cancer: chemotherapy and biological therapy

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Bevacizumab in combination with capecitabine

Bevacizumab in combination with capecitabine is not recommended within its marketing
authorisation for the first-line treatment of metastatic breast cancer, that is, when treatment with
other chemotherapy options including taxanes or anthracyclines is not considered appropriate,
or when taxanes or anthracyclines have been used as part of adjuvant treatment within the past
12 months.
People currently receiving bevacizumab in combination with capecitabine that is not
recommended according to above should have the option to continue treatment until they and
their clinician consider it appropriate to stop.
These recommendations are from Bevacizumab in combination with capecitabine for the firstline treatment of metastatic breast cancer NICE technology appraisal guidance 263.
NICE has produced information for the public explaining this guidance.
Bevacizumab in combination with a taxane
Bevacizumab in combination with a taxane is not recommended for the first-line treatment of
metastatic breast cancer.
Patients currently receiving bevacizumab in combination with a taxane for the first-line treatment
of metastatic breast cancer should have the option to continue therapy until they and their
clinicians consider it appropriate to stop.
These recommendations are from Bevacizumab in combination with a taxane for the first-line
treatment of metastatic breast cancer NICE technology appraisal guidance 214.
NICE has produced information for the public explaining this guidance.
Using gemcitabine in combination with paclitaxel
Gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an
option for the treatment of metastatic breast cancer only when docetaxel monotherapy or
docetaxel plus capecitabine are also considered appropriate.
This recommendation is from Gemcitabine for the treatment of metastatic breast cancer NICE
technology appraisal guidance 116.

Advanced breast cancer pathway

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Advanced breast cancer: chemotherapy and biological therapy

NICE Pathways

NICE has produced information for the public explaining this guidance.

Resources
The following implementation tools are relevant to this part of the pathway.
Advanced breast cancer: multiple guidance clinical audit tool
Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast
cancer: costing statement
Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast
cancer: costing statement
Gemcitabine for the treatment of metastatic breast cancer: costing statement

Second-line therapy

For patients with advanced breast cancer who are not suitable for anthracyclines (because they
are contraindicated or because of prior anthracycline treatment either in the adjuvant or
metastatic setting), offer single-agent vinorelbine or capecitabine as second-line therapy.
Eribulin
Eribulin is not recommended, within its licensed indication, for the treatment of locally
advanced or metastatic breast cancer that has progressed after at least two chemotherapy
regimens for advanced disease.
People currently receiving eribulin, within its licensed indication, for the treatment of locally
advanced or metastatic breast cancer that has progressed after at least two chemotherapy
regimens should have the option to continue therapy until they and their clinicians consider it
appropriate to stop.
These recommendations are from Eribulin for the treatment of locally advanced or metastatic
breast cancer NICE technology appraisal guidance 250.
NICE has produced information for the public explaining this guidance.

Advanced breast cancer pathway

Copyright NICE 2015.

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Advanced breast cancer: chemotherapy and biological therapy

NICE Pathways

Resources
The following implementation tools are relevant to this part of the pathway.
Early and locally advanced breast cancer: clinical audit tool
Eribulin for the treatment of locally advanced or metastatic breast cancer: costing statement

Third-line therapy

For patients with advanced breast cancer who are not suitable for anthracyclines (because they
are contraindicated or because of prior anthracycline treatment either in the adjuvant or
metastatic setting), offer single-agent capecitabine or vinorelbine (whichever was not used as
second-line treatment) as third-line treatment.
Eribulin
Eribulin is not recommended, within its licensed indication, for the treatment of locally
advanced or metastatic breast cancer that has progressed after at least two chemotherapy
regimens for advanced disease.
People currently receiving eribulin, within its licensed indication, for the treatment of locally
advanced or metastatic breast cancer that has progressed after at least two chemotherapy
regimens should have the option to continue therapy until they and their clinicians consider it
appropriate to stop.
These recommendations are from Eribulin for the treatment of locally advanced or metastatic
breast cancer NICE technology appraisal guidance 250.
NICE has produced information for the public explaining this guidance.

Resources
The following implementation tools are relevant to this part of the pathway.
Early and locally advanced breast cancer: clinical audit tool
Eribulin for the treatment of locally advanced or metastatic breast cancer: costing statement

Advanced breast cancer pathway

Copyright NICE 2015.

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Advanced breast cancer: chemotherapy and biological therapy

NICE Pathways

10 Patients with ER-positive breast cancer who have been treated with

chemotherapy as first line

No additional information

11 Endocrine therapy
See Advanced breast cancer / Advanced breast cancer: endocrine therapy

12 Using trastuzumab
Trastuzumab in combination with paclitaxel (combination trastuzumab is currently only licensed
for use with paclitaxel) is recommended as an option for people with tumours expressing HER2
scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in
whom anthracycline treatment is inappropriate.
Trastuzumab monotherapy is recommended as an option for people with tumours expressing
HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for
metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and
a taxane where these treatments are appropriate. It should also have included hormonal
therapy in suitable oestrogen receptor positive patients.
HER2 levels should be scored using validated immunohistochemical techniques and in
accordance with published guidelines. Laboratories offering tissue sample immunocytochemical
or other predictive tests for therapy response should use validated standardised assay methods
and participate in and demonstrate satisfactory performance in a recognised external quality
assurance scheme.
These recommendations are from Guidance on the use of trastuzumab for the treatment of
advanced breast cancer NICE technology appraisal guidance 34.
NICE has produced information for the public explaining this guidance.

Resources
The following implementation tool is relevant to this part of the pathway.

Advanced breast cancer pathway

Copyright NICE 2015.

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Advanced breast cancer: chemotherapy and biological therapy

NICE Pathways

Advanced breast cancer: multiple guidance clinical audit tool

13 Extracranial disease progression while receiving trastuzumab

For patients who are receiving treatment with trastuzumab for advanced breast cancer,
discontinue treatment with trastuzumab at the time of disease progression outside the central
nervous system. Do not discontinue trastuzumab if disease progression is within the central
nervous system alone.

Resources
The following implementation tools are relevant to this part of the pathway.
Advanced breast cancer: audit support
Early and locally advanced breast cancer and Advanced breast cancer: costing report
Early and locally advanced breast cancer and Advanced breast cancer: costing template
Advanced breast cancer: slide set

14 Stop trastuzumab
No additional information

Advanced breast cancer pathway

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Glossary
ER
Oestrogen receptor
HER2
Human epidermal growth factor receptor 2
PET-CT
Positron emission tomography fused with computed tomography
DCIS
Ductal carcinoma in situ
MDT
Multidisciplinary team

Sources
Advanced breast cancer (2009 updated 2014) NICE guideline CG81
Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast
cancer (2012) NICE technology appraisal guidance 263
Eribulin for the treatment of locally advanced or metastatic breast cancer (2012) NICE
technology appraisal guidance 250
Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast
cancer (2011) NICE technology appraisal guidance 214
Gemcitabine for the treatment of metastatic breast cancer (2007) NICE technology appraisal
guidance 116
Guidance on the use of trastuzumab for the treatment of advanced breast cancer (2002) NICE
technology appraisal guidance 34
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NICE Pathways

Your responsibility
The guidance in this pathway represents the view of NICE, which was arrived at after careful
consideration of the evidence available. Those working in the NHS, local authorities, the wider
public, voluntary and community sectors and the private sector should take it into account when
carrying out their professional, managerial or voluntary duties. Implementation of this guidance
is the responsibility of local commissioners and/or providers. Commissioners and providers are
reminded that it is their responsibility to implement the guidance, in their local context, in light of
their duties to avoid unlawful discrimination and to have regard to promoting equality of
opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent
with compliance with those duties.

Copyright
Copyright National Institute for Health and Care Excellence 2015. All rights reserved. NICE
copyright material can be downloaded for private research and study, and may be reproduced
for educational and not-for-profit purposes. No reproduction by or for commercial organisations,
or for commercial purposes, is allowed without the written permission of NICE.

Contact NICE
National Institute for Health and Care Excellence
Level 1A, City Tower
Piccadilly Plaza
Manchester
M1 4BT
www.nice.org.uk
nice@nice.org.uk
0845 003 7781

Advanced breast cancer pathway

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