Treatment of early breast cancer which overexpresses
human epidermal growth factor receptor-2 (HER2)
(initiated by a specialist) | Treatment of metastatic
breast cancer in patients with HER2-positive tumours
who have not received chemotherapy for metastatic
breast cancer and in whom anthracycline treatment is
inappropriate (in combination with paclitaxel or
docetaxel) (initiated by a specialist) | Treatment of
metastatic breast cancer in postmenopausal patients
with hormone-receptor positive HER2-positive tumours
not previously treated with trastuzumab (in
combination with an aromatase inhibitor) (initiated by a
specialist)
▶BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION
▶Adult: (consult product literature or local protocols)
continued →
Monotherapy for metastatic breast cancer in patients
with tumours that overexpress HER2 who have received
at least 2 chemotherapy regimens including, where
appropriate, an anthracycline and a taxane (initiated by
a specialist)
▶BY INTRAVENOUS INFUSION, OR BY SUBCUTANEOUS INJECTION
▶Adult: Women with oestrogen-receptor-positive breast
cancer should also have received hormonal therapy
(consult product literature or local protocols)
Treatment of metastatic gastric cancer in patients with
HER2-positive tumours who have not received treatment
for metastatic gastric cancer (in combination with
Immune system and malignant disease
capecitabine or fluorouracil and cisplatin) (initiated by a
specialist)
▶BY INTRAVENOUS INFUSION
▶Adult: (consult product literature or local protocols)
PDF pages 957, 958
Severe dyspnoea at rest
PDF page 958
Coronary artery disease. history of
hypertension. symptomatic heart failure. uncontrolled
arrhythmias
PDF page 958
When
prescribing, dispensing or administering, check that this is
the correct preparation—trastuzumab is not
interchangeable with trastuzumab emtansine.
Trastuzumab is a biological medicine. Biological
medicines must be prescribed and dispensed by brand
name, see Biological medicines and Biosimilar medicines,
under Guidance on prescribing p. 1.
PDF page 958
NICE decisions
▶Guidance on the use of trastuzumab for the treatment of
advanced breast cancer (March 2002) NICE TA34
Trastuzumab in combination with paclitaxel is
recommended as an option for patients with tumours
expressing human epidermal growth factor receptor 2
(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 patients 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.
www.nice.org.uk/guidance/ta34
▶Trastuzumab for the adjuvant treatment of early-stage
HER2-positive breast cancer (August 2006) NICE TA107
Trastuzumab, given at 3-week intervals for 1 year or until
disease recurrence (whichever is the shorter period), is
recommended as an option for women with early-stage
HER2-positive breast cancer following surgery,
chemotherapy (neoadjuvant or adjuvant) and radiotherapy
(if applicable).
www.nice.org.uk/guidance/ta107
▶Lapatinib or trastuzumab in combination with an aromatase
inhibitor for the first-line treatment of metastatic hormone-
receptor-positive breast cancer that overexpresses HER2
(June 2012) NICE TA257
Lapatinib or trastuzumab in combination with an
aromatase inhibitor is not recommended for first-line
treatment in postmenopausal women of metastatic
hormone-receptor-positive breast cancer that
overexpresses human epidermal growth factor receptor 2
(HER2).
Postmenopausal women currently receiving lapatinib or
trastuzumab in combination with an aromatase inhibitor
for this indication should have the option to continue
treatment until they and their clinician consider it
appropriate to stop.
www.nice.org.uk/guidance/ta257
▶Pertuzumab with trastuzumab and docetaxel for treating
HER2-positive breast cancer (March 2018) NICE TA509
Pertuzumab, in combination with trastuzumab and
docetaxel, is recommended, within its marketing
authorisation, for treating HER2-positive metastatic or
locally recurrent unresectable breast cancer, in adults who
have not had previous anti-HER2 therapy or chemotherapy
for their metastatic disease, only if the manufacturer
provides pertuzumab within the agreed commercial access
arrangement.
www.nice.org.uk/guidance/ta509
▶Trastuzumab for the treatment of HER2-positive metastatic
gastric cancer (November 2010) NICE TA208
Trastuzumab in combination with cisplatin and
capecitabine or fluorouracil is recommended for human
epidermal growth factor receptor-2-positive metastatic
adenocarcinoma of the stomach or gastro-oesophageal
junction in patients who:
. have not received treatment for metastatic disease and
. have tumours expressing high levels of HER2 as defined
by a positive immunohistochemistry score of 3.
www.nice.org.uk/guidance/ta208
Scottish Medicines Consortium (SMC) decisions
SMC No. 928/13
The Scottish Medicines Consortium has advised (January
2014) that subcutaneous trastuzumab injection
(Herceptin ®) is accepted for restricted use within NHS
Scotland for the treatment of adults with HER2 positive
metastatic breast cancer and early breast cancer, when
used within licensed indications excluding use in
combination with an aromatase inhibitor for the treatment
of postmenopausal patients with hormone-receptor
positive metastatic breast cancer, not previously treated
with trastuzumab.
SMC No. 623/10
The Scottish Medicines Consortium has advised (October
2015) that trastuzumab solution for infusion (Herceptin ®)
is accepted for restricted use within NHS Scotland in
combination with capecitabine or fluorouracil and
cisplatin for the treatment of patients with HER2 positive
metastatic adenocarcinoma of the stomach or gastro-
oesophageal junction, who have not received prior anti-
cancer treatment for their metastatic disease. It is
restricted to patients with metastatic gastric cancer whose
tumours have HER2 over-expression, as determined by an
accurate and validated assay.
PDF pages 958, 959
