Breast SACT Regimens

The information contained in these regimens is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. The treatment regimen to be used should take into account factors such as histology, molecular pathology, age, performance status, co-morbidities and the patient’s preference. Each treatment regimen has advantages and disadvantages, and there may be more than one good option. In addition, treatment choices can change over time as more evidence becomes available. Use of these documents is the responsibility of the prescribing clinician and is subject to the HSE.ie terms of use.

Please email any comments or feedback on these regimens to oncologydrugs@cancercontrol.ie

Recommendations on Reporting on HER2 Status in Breast Cancer Patients

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 which are available here.

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).

For information on open clinical trials please refer to the Cancer Trials Ireland website here and also to basket trials here.

Breast Chemotherapy Regimens

**Neoadjuvant / Adjuvant Treatments**
Regimen Name	Indication
Anastrozole Regimen	00254b Adjuvant treatment of hormone receptor positive early invasive breast cancer in post-menopausal women. 00254c Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
Capecitabine Monotherapy* Regimen	00216f Adjuvant treatment of stage I to IIIB, triple negative breast cancer (TNBC) in patients with residual invasive disease after neoadjuvant chemotherapy treatment
CARBOplatin (AUC6) and Weekly PACLitaxel (80mg/m²) followed by Dose Dense DOXOrubicin Cyclophosphamide Therapy-Triple Negative Breast Cancer Therapy Regimen	00348a Neoadjuvant treatment of triple negative breast carcinoma.
Weekly CARBOplatin (AUC 2) and PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin cycloPHOSphamide Therapy - Triple Negative Breast Cancer Therapy Regimen	00734a Neoadjuvant treatment of triple negative breast carcinoma
Cyclophosphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 21 day Regimen	00381a Adjuvant treatment for breast carcinoma in patients who are considered unsuitable for anthracycline therapy.
Cyclophosphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 28 day Regimen	00378a Adjuvant treatment for breast carcinoma in patients who are considered unsuitable for anthracycline therapy.
Cyclophosphamide (oral) Methotrexate and 5-Fluorouracil (CMF) Therapy Regimen	00377a Adjuvant treatment for breast carcinoma in patients who are considered unsuitable for anthracycline therapy.
Dose Dense Doxorubicin, Cyclophosphamide (AC 60/600) 14 day followed by weekly PACLitaxel (80) and Trastuzumab 21 day Therapy (DD AC-TH) Regimen	00745aa Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer 00745b Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer
DOCEtaxel/Cyclophosphamide (TC) Therapy-21 day Regimen	00250a Adjuvant treatment of patients with high risk node-positive or node-negative early operable breast cancer.
DOCEtaxel, CARBOplatin and Trastuzumab (TCH)-21 days Regimen	00258a Adjuvant treatment HER2 positive early breast cancer.
DOXOrubicin and Cycophosphamide(AC 60/600)Therapy- 21 day Regimen	00252a Adjuvant Treatment of High Risk Node Negative or Node Positive Breast Cancer
DOXOrubicin, Cyclophosphamide followed by weekly PACLitaxel Therapy (AC-T) Regimen	00260a Neoadjuvant or Adjuvant Treatment of High Risk Node Negative or Node Positive Breast Cancer
Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLitaxel (80) 7 day Therapy (DD AC-T) Regimen	00485a Adjuvant Treatment of High Risk Node Negative or Node Positive Breast Cancer 00485b Neoadjuvant Treatment of High Risk Node Negative or Node Positive Breast Cancer.
Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLitaxel (175) 14 day Therapy (DD AC-T) Regimen	00278a Adjuvant treatment of High Risk Node Negative or Node Positive Breast Cancer 00278b Neoadjuvant treatment of High Risk Node Negative or Node Positive Breast Cancer
DOXOrubicin, Cyclophosphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (AC-TH) Regimen	00432a Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. 00432b Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer.
Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (DD AC-TH) Regimen	00433a Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. 00433b Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer
Dose Dense DOXOrubicin, cycloPHOSphamide (AC 60/600) 14 day followed by PACLitaxel (175) 14 day and Trastuzumab Therapy (DD AC-TH) Regimen	00316a Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. 00316b Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer.
epiRUBicin 90 and cycloPHOSphamide (EC90) Therapy Regimen	00262a Adjuvant treatment for operable breast carcinoma
Exemestane Monotherapy Regimen	00376a Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. 00376b Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior adjuvant endocrine therapy.
5-Fluorouracil, epiRUBicin 100 and Cyclophosphamide (FEC 100) Therapy Regimen	00265a Neoadjuvant treatment for breast carcinoma 00265b Adjuvant treatment for breast carcinoma
Letrozole Monotherapy Regimen	00371a Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. 00371b Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior adjuvant endocrine therapy for 5 years. 00371d Neo-adjuvant treatment of postmenopausal women with hormone receptor positive breast cancer.
Neratinib Therapy Regimen	00720a Extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
PACLitaxel (80) and Trastuzumab Therapy – 7 day (12 weeks) Regimen	00512a Adjuvant Treatment of HER2 positive, Node-Negative Breast Cancer of tumor size ≤3cm
Pertuzumab/Trastuzumab (Phesgo®), PACLitaxel and CARBOplatin Therapy (TRAIN-2) Regimen	00790a Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
DOCEtaxel, CARBOplatin and Pertuzumab/Trastuzumab (Phesgo®)(TCHP) Therapy Regimen	00789a Neoadjuvant treatment of adult patients with HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence.
DOCEtaxel, CARBOplatin, Trastuzumab and Pertuzumab (TCHP) Therapy Regimen	00722a Neoadjuvant treatment of adult patients with HER2- positive locally advanced, inflammatory or early breast cancer at high risk of recurrence.
DOCEtaxel, CARBOplatin, Trastuzumab (S/C) and Pertuzumab (TCH(S/C)P) Therapy Regimen	00731a Neoadjuvant treatment of adult patients with HER2- positive locally advanced, inflammatory or early breast cancer at high risk of recurrence.
Pertuzumab, Trastuzumab, PACLItaxel and CARBOplatin Therapy (TRAIN-2) Regimen	00775a Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Pertuzumab and Trastuzumab and Chemotherapy Regimen	00350a Pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence 00350b Pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence
Sacituzumab Govitecan Therapy Regimen	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.
Tamoxifen Regimen	00253a Adjuvant treatment of oestrogen receptor positive breast cancer in pre- or post-menopausal women.
Trastuzumab (IV) Monotherapy - 21 days Regimen	00200b HER2 positive early breast cancer (EBC)
Trastuzumab Subcutaneous 21 days - Early Breast Cancer Regimen	HER2 positive early breast cancer (EBC): 00285a Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) 00285b Following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel 00285c In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. 00285d In combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter
Trastuzumab Emtansine (Kadcyla^®) Early Breast Cancer Therapy-21 days Regimen	00659a As a single agent is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy
Zoledronic Acid Regimen	00545a Adjuvant treatment of breast cancer in endocrine depleted pre- or post menopausal women

* Unlicensed indication. See Regimen for more details.

**Locally Advanced / Metastatic Regimens**
Regimen Name	Indication
Anastrozole Regimen	00254a Treatment of hormone receptor positive locally advanced or metastatic breast cancer in post-menopausal women
Atezolizumab and nab-PACLitaxel Therapy Regimen	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 Regimen	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 Regimen	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 Regimen	00738a In combination with PACLitaxel for the treatment of adult patients with triple negative or HER²-negative metastatic breast cancer.
Capecitabine Monotherapy Regimen	00216a Treatment of patients with locally advanced or metastatic breast cancer.
CARBOplatin (AUC 4-6) Monotherapy- 21 day Regimen	00261j* Metastatic breast carcinoma.
CARBOplatin (AUC 4-6) Monotherapy- 28 day Regimen	00251j* Metastatic breast carcinoma.
Cyclophosphamide (oral) Methotrexate and 5-Fluorouracil (CMF) Therapy Regimen	00377b Metastatic breast carcinoma.
Cyclophosphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 21 day Regimen	00381b Metastatic breast carcinoma.
Cyclophosphamide (IV) Methotrexate and 5-Fluorouracil (CMF) Therapy 28 day Regimen	00378b Metastatic breast carcinoma.
Denosumab 120mg Therapy Regimen	00741a For the prevention of skeletal related events in adult patients with malignancies involving bone.
DOCEtaxel Monotherapy 75mg/m² – 21 day cycle Regimen	00203h Treatment of advanced breast cancer.
DOCEtaxel Monotherapy 100mg/m² – 21 day cycle Regimen	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 Regimen	00423a Treatment of Locally Advanced or Metastatic Breast Carcinoma.
DOXOrubicin (Pegylated Liposomal) 50mg/m² -28 days Regimen	00205a Monotherapy for patients with metastatic breast cancer.
epiRUBicin 75 + cycloPHOSphamide (EC75) Therapy Regimen	00263a Metastatic breast carcinoma.
eriBULin Monotherapy Regimen	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 Regimen	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 Regimen	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 Regimen	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 Regimen	00269a Metastatic breast carcinoma
Fulvestrant Monotherapy Regimen	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) Therapy - 21 days Regimen	00430a Treatment of locally recurrent metastatic triple negative breast cancer.
Lapatinib and Capecitabine Regimen	00217a 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 Regimen	00371c Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status.
PACLitaxel Monotherapy 80mg/m²Day 1, 8, 15 and 22 – 28 Day Regimen	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 and 15 Monotherapy-28 Day Regimen	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 Regimen	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 Regimen	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 Regimen	00815 Adjuvant treatment of HER2 positive, node-negative breast cancer of tumour size ≤ 3cm
Palbociclib Therapy-28day Regimen	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 Regimen	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 Regimen	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 PACLitaxelTherapy-21 day cycle Regimen	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 PACLitaxel 80mg/m2 weekly – 21 day cycle Regimen	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 Regimen	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 Regimen	00798a 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 Regimen	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 Regimen	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-28 days Regimen	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.
Talazoparib Therapy Regimen Information on BRCA testing for Talazoparib	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 Regimen	00253b Treatment of oestrogen receptor positive advanced breast cancer in pre- or post-menopausal women.
Trastuzumab (IV) Monotherapy - 7 days Regimen	00201a The treatment of patients with HER2 positive metastatic breast cancer (MBC).
Trastuzumab (IV) Monotherapy - 21 days Regimen	00200a HER2 positive metastatic breast cancer (MBC)
Trastuzumab Subcutaneous-21 days - Metastatic Breast Carcinoma Regimen	HER2 positive metastatic breast cancer (MBC): 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 Emtansine (Kadcyla®)-21 days Regimen	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.
Intravenous Vinorelbine Therapy-21 days Regimen	00232a Advanced breast cancer.
Oral Vinorelbine Monotherapy-7days Regimen	00259a Advanced breast cancer.
Zoledronic Acid Therapy-28 days Regimen	00723a Prevention of skeletal related events in malignancies involving bone metastases
Zoledronic Acid Therapy-3 monthly Regimen	00724a Prevention of skeletal related events in malignancies involving bone metastases
Zoledronic Acid Therapy-6 monthly Regimen	00725a Prevention of skeletal related events in malignancies involving bone metastases

*Unlicensed indication. See protocol for more details.