Locally Advanced / Metastatic Regimen
Recommendations on reporting on HER-2 status in breast cancer patient (PDF, 452 KB, 1 page)
Oncotype-DX
Use of Oncotype DX for gene expression profiling to support chemotherapy decision making in patients with Hormone Receptor positive, HER2 negative, lymph node negative early stage breast cancer was recommended by the NCCP Technology Review Committee in August 2011 in line with eligibility guidelines drafted by the Irish Society of Medical Oncology.
ISMO Evidence Based Guideline Oncotype DX (PDF, 751 KB, 40 pages)
The use of Oncotype DX has been extended to patients with Hormone Receptor positive, HER2-negative, lymph node positive patients (1-3nodes) breast cancer patients in line with the recommendation of the NCCP Systemic Anti-Cancer Therapy Breast Clinical Advisory Group (November 2019).
Anastrozole
Indication
00254a
Treatment of hormone receptor positive locally advanced or metastatic breast cancer in post-menopausal women
Atezolizumab and nab-PACLitaxel Therapy
Indication
00688a
Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Bevacizumab 10 mg/kg –14 days
Indication
00212c
In combination with paclitaxel is indicated for first-line treatment of adult patients with HER2-negative metastatic breast cancer.
Bevacizumab 15 mg/kg – 21 days
Indication
00215e
In combination with paclitaxel is indicated for first-line treatment of adult patients with HER2-negative metastatic breast cancer.
Bevacizumab 10mg/kg and PACLitaxel 80mg/m2 Therapy
Indication
00738a
In combination with PACLitaxel for the treatment of adult patients with triple negative or HER2-negative metastatic breast cancer.
Capecitabine Monotherapy
Capivasertib and Fulvestrant Therapy
Indication
00947a
In combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER) positive, HER2 negative locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration following recurrence or progression on or after an endocrine-based regimen.
In pre- or peri-menopausal females, therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
CARBOplatin (AUC 4-6) Monotherapy- 21 day
CARBOplatin (AUC 4-6) Monotherapy- 28 day
cycloPHOSphamide (oral) Methotrexate and 5-Fluorouracil (CMF) Therapy
cycloPHOSphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 21 day
cycloPHOSphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 28 day
DOCEtaxel Monotherapy 75mg/m2 - 21 day cycle
DOCEtaxel Monotherapy 100mg/m2 - 21 day cycle
Indication
00202a
DOCEtaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer.
DOXOrubicin 50mg/m2/DOCEtaxel 75mg/m2(AT 50/75) Therapy - 21 day cycle
DOXOrubicin (Pegylated Liposomal) 50mg/m2 -28 days
epiRUBicin 75 + cycloPHOSphamide (EC75) Therapy
eriBULin Monotherapy
Indication
00228a
Treatment of locally advanced or metastatic breast cancer which has progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
eriBULin Monotherapy – 28 Day
Indication
00743a
Treatment of locally advanced or metastatic breast cancer which has progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Everolimus and Exemestane Therapy
Indication
00322a
Treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Exemestane Monotherapy
Indication
00376c
Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status.
5-Fluorouracil, epiRUBicin 50 and cycloPHOSphamide (FEC50) Therapy
Fulvestrant Monotherapy
Indication
00361a
Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy.
00361b
Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease progression on or after adjuvant anti-oestrogen therapy.
Gemcitabine and CARBOplatin (AUC2) - 21 day
Lapatinib and Capecitabine Therapy
Indication
0217a
Treatment of adult patients with breast cancer, whose tumours overexpress HER2 in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
Letrozole Monotherapy
Indication
00371c
Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status.
00371e
First-line treatment in postmenopausal women with hormone dependent advanced breast cancer.
PACLitaxel Monotherapy 80mg/m2 Day 1, 8, 15 and 22 – 28 Day
Indication
00226a*
Treatment of metastatic breast carcinoma (mBC) in patients who have either failed or are not candidates for standard, anthracycline-containing therapy.
PACLitaxel 80mg/m2 Day 1, 8, 15 Monotherapy-28 Day
Indication
00621b*
Treatment of metastatic breast carcinoma (mBC) in patients who have either failed or are not candidates for standard, anthracycline-containing therapy
nab-PACLitaxel Monotherapy – 21 day cycle
Indication
00230a
Treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.
nab-PACLitaxel Weekly Monotherapy–28 day
Indication
00736a
Treatment of metastatic breast carcinoma (mBC) in patients who have either failed or are not candidates for standard, anthracycline-containing therapy.
PACLitaxel 80 (7 day) and Trastuzumab (21 day) Therapy
Indication
00815a
Adjuvant treatment of HER2 positive, node-negative breast cancer of tumour size ≤ 3cm
Palbociclib Therapy-28day
Indication
00414a
Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor
00414b
Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy
Pertuzumab and Trastuzumab (Phesgo®) Maintenance Therapy
Indication
00785a
Pertuzumab/ trastuzumab (Phesgo®) for the maintenance treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, where this is a continuation of treatment for patients who have completed the chemotherapy component of the treatment.
Pertuzumab and Trastuzumab and DOCEtaxel Therapy-21 day cycle
Indication
00204a
Pertuzumab is indicated in combination with trastuzumab
and DOCEtaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or
chemotherapy for their metastatic disease.
Pertuzumab Trastuzumab and weekly PACLitaxel Therapy-21 day cycle
Indication
00507a
Pertuzumab is indicated in combination with trastuzumab and PACLitaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are intolerant of, have had significant toxicity to or are deemed clinically unsuitable for DOCEtaxel.
Pertuzumab/Trastuzumab (Phesgo®) and Weekly PACLitaxel Therapy - 21 day cycle
Indication
00797a
Pertuzumab/trastuzumab (Phesgo®) is indicated in combination with PACLitaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are intolerant of, have had significant toxicity to or are deemed clinically unsuitable for DOCEtaxel
Pertuzumab and Trastuzumab (Phesgo®) and DOCEtaxel Therapy - 21 day cycle
Indication
00796a
Pertuzumab/ trastuzumab (Phesgo®) is indicated in combination with DOCEtaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease.
Pertuzumab/Trastuzumab (Phesgo®) and vinorelbine
Indication
00798
Pertuzumab/trastuzumab (Phesgo®) and vinorelbine for the treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are deemed clinically unsuitable for taxane based therapy
Pertuzumab and Trastuzumab Therapy
Indication
00726a
Pertuzumab in combination with trastuzumab for the maintenance
treatment of adult patients with HER2-positive metastatic or locally
recurrent unresectable breast cancer, where this is a continuation of treatment for patients who have completed the chemotherapy
component of the treatment.
Pertuzumab Trastuzumab and Vinorelbine
Indication
00526a
Pertuzumab in combination with trastuzumab and vinorelbine for the treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are deemed clinically unsuitable for taxane based therapy
Ribociclib Therapy (Metastatic) -28 days
Indication
00525a
Treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor.
00525b
Treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine based therapy or in women who have received prior endocrine therapy.
In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist
Sacituzumab Govitecan Therapy
Indication
00794a
As monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.
Talazoparib Therapy
Indication
00605a
Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy or be considered unsuitable for endocrine-based therapy.
Tamoxifen Monotherapy
Indication
00253b
Treatment of oestrogen receptor positive advanced breast cancer in pre- or post-menopausal women.
Trastuzumab (IV) Monotherapy - 7 days
Trastuzumab (IV) Monotherapy - 21 days
Trastuzumab Subcutaneous_21 days - Metastatic Breast Carcinoma
Indication
00272a
As monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
00272b
In combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
00272c
In combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
00272d
In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Trastuzumab Deruxtecan 5.4mg/kg (Enhertu®) Therapy
Indication
00776a
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens
00776b
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Trastuzumab Emtansine (Kadcyla®)-21 days
Indication
00206a
Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Patients should have either:
- Received prior therapy for locally advanced or metastatic disease, or
Developed disease recurrence during or within six months of completing adjuvant therapy.
Tucatinib, Trastuzumab and Capecitabine Therapy
Indication
00936a
Tucatinib in combination with trastuzumab and capecitabine, for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.