Breast Cancer (Recurrent or Metastatic)

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Breast Cancer (Recurrent or Metastatic) Treatment Regimens

Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The National Comprehensive Cancer Network Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Note: All recommendations are category 2A unless otherwise indicated.

Systemic Therapy for ER- and/or PR-Positive Recurrent or Stage IV (M1) Disease1,a

REGIMEN

DOSING

HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression2-6,b

Preferred Regimens

Abemaciclib + Anastrozole (Category 1)7-9,c,d

Days 1-28: Abemaciclib 150mg orally twice daily

Days 1-28: Anastrozole 1mg orally once daily.

Repeat cycle every 4 weeks.

Abemaciclib + Exemestane (Category 1)7,8,10,c,d

Days 1-28: Abemaciclib 150mg orally twice daily

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Abemaciclib + Fulvestrant (Category 1)8,11,12,c,d

Days 1-28: Abemaciclib 150mg orally twice daily

Day 1 and 15: Fulvestrant 500mg IM.

Administer one 4-week cycle, followed by:

Days 1-28: Abemaciclib 150mg orally twice daily

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Abemaciclib + Letrozole (Category 1)7,8,13,c,d

Days 1-28: Abemaciclib 150mg orally twice daily

Days 1-28: Letrozole 2.5mg orally once daily

Repeat cycle every 4 weeks.

Anastrozole9,13-17

Days 1-28: Anastrozole 1mg once orally.

Repeat cycle every 4 weeks.

Everolimus + Exemestane10,18,19,d

Days 1-28: Everolimus 10mg orally once daily

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Everolimus + Fulvestrant12,18-20,d

Days 1-28: Everolimus 10mg orally once daily

Days 1 and 15: Fulvestrant 500mg IM.

Administer for one 28-day cycle, followed by:

Days 1-28: Everolimus 10mg orally once daily

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Everolimus + Tamoxifen18,19,21,d

Days 1-28: Everolimus 10mg orally once daily

Days 1-28: Tamoxifen 20mg orally once daily.

Repeat cycle every 4 weeks.

Exemestane10,14,22,23

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Fulvestrant (Category 1)12,20

Days 1 and 15: Fulvestrant 500mg IM.

Administer for one 28-day cycle, followed by:

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Fulvestrant + Alpelisib (for PIK3CA-mutated tumors) (Category 1)12,24,25,e

Days 1-28: Alpelisib 300mg orally once daily

Days 1 and 15: Fulvestrant 500mg IM.

Administer for one 4-week cycle, followed by:

Days 1-28: Alpelisib 300mg orally once daily

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Letrozole13-15,26,27

Days 1-28: Letrozole 2.5mg orally once daily.

Repeat cycle every 4 weeks.

Palbociclib + Anastrozole (Category 1)9,28,29,c

Days 1-21: Palbociclib 125mg orally once daily

Days 1-28: Anastrozole 1mg orally once daily.

Repeat cycle every 4 weeks.

Palbociclib + Exemestane (Category 1)10,28,29,c

Days 1-21: Palbociclib 125mg orally once daily

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Palbociclib + Fulvestrant (Category 1)12,29,30,c

Days 1-21: Palbociclib 125mg orally once daily

Days 1 and 15: Fulvestrant 500mg IM daily.

Administer for one 28-day cycle, followed by:

Days 1-21: Palbociclib 125mg orally once daily

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Palbociclib + Letrozole (Category 1)13,28,29,c

Days 1-21: Palbociclib 125mg orally once daily

Days 1-28: Letrozole 2.5mg orally once daily.

Repeat cycle every 4 weeks.

Ribociclib + Anastrozole (Category 1)9,31,32,c

Days 1-21: Ribociclib 600mg orally once daily

Days 1-28: Anastrozole 1mg orally once daily.

Repeat cycle every 4 weeks.

Ribociclib + Exemestane (Category 1)10,31,32,c

Days 1-21: Ribociclib 600mg orally once daily

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Ribociclib + Fulvestrant (Category 1)12,32,33,c

Days 1-21: Ribociclib 600mg orally once daily

Days 1-15: Fulvestrant 500mg IM.

Administer one 4-week cycle, followed by:

Days 1-21: Ribociclib 600mg orally once daily

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Ribociclib + Letrozole (Category 1)13,31,32,c

Day 1-21: Ribociclib 600mg orally once daily

Days 1-28: Letrozole 2.5mg orally once daily.

Repeat cycle every 4 weeks.

Tamoxifen21,34,35

Day 1-28: Tamoxifen 20mg orally once daily.

Repeat cycle every 4 weeks.

Toremifene36

Days 1-28: Toremifene 60mg orally once daily.

Repeat cycle every 4 weeks.

Useful in Certain Circumstances

Abemaciclib8,37,d,f

Days 1-28: Abemaciclib 200mg orally twice daily.

Repeat cycle every 4 weeks.

Estradiol38

Days 1-28: Estradiol 10mg orally three times daily.

Repeat cycle every 4 weeks.

Fluoxymesterone39,40

Days 1-28: Fluoxymesterone 10mg orally twice daily.

Repeat cycle every 4 weeks.

Megestrol41,42

Days 1-28: Megastrol 40mg orally four times daily.

Repeat cycle every 4 weeks.

Ribociclib + Tamoxifen (Category 1)21,32,43

Days 1-21: Ribociclib 600mg orally once daily

Days 1-28: Tamoxifen 20mg orally once daily.

Repeat cycle every 4 weeks.

HER2-Positive and Postmenopausal44-46,g,h

Anastrozole9,14

Days 1-28: Anastrozole 1mg orally once daily.

Repeat cycle every 4 weeks.

Anastrozole + Lapatinib9,47,48

Days 1-28: Anastrozole 1mg orally once daily

Days 1-28: Lapatinib 1,500mg orally once daily.

Repeat cycle every 4 weeks.

Anastrozole + Lapatinib + Trastuzumab9,47-49

Days 1-28: Anastrozole 1mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1-28: Anastrozole 1mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Anastrozole + Trastuzumab9,49,50

Days 1-21: Anastrozole 1mg orally once daily

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Exemestane10,14

Days 1-28: Exemestane 25mg orally once daily.

Repeat cycle every 4 weeks.

Exemestane + Lapatinib10,47,48

Days 1-28: Exemestane 25mg orally once daily

Days 1-28: Lapatinib 1,500mg orally once daily.

Repeat cycle every 4 weeks.

Exemestane + Lapatinib + Trastuzumab10,47-49

Days 1-28: Exemestane 25mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/m2 IV over 90 minutes on week 1, then 2mg/m2 IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1-28: Exemestane 25mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/m2 IV starting with cycle 2 cycled every 3 weeks.

Exemestane + Trastuzumab10,49,50

Days 1-28: Exemestane 25mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV starting week 2 cycled weekly.

OR

Days 1-28: Exemestane 25mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/m2 IV starting with cycle 2 cycled every 3 weeks.

Fulvestrant12,20

Days 1 and 15: Fulvestrant 500mg IM.

Administer for one 28-day cycle, followed by:

Day 1: Fulvestrant 500mg IM.

Repeat cycle every 4 weeks.

Fulvestrant + Trastuzumab12,49,51,52

Days 1 and 15: Fulvestrant 500mg IM on cycle 1, followed by:

Day 1: Fulvestrant 500mg IM starting with cycle 2 cycled every 4 weeks, with:

Day 1: Trastuzmab 4mg/kg IV over 90 minutes on week 1, then 2mg/m2 IV starting week 2 cycled weekly.

OR

Days 1 and 15: Fulvestrant 500mg IM on cycle 1, followed by:

Day 1: Fulvestrant 500mg IM starting with cycle 2 cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV 90 minutes on cycle 1, then 6mg/m2 IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Letrozole13,15,26,27,53

Days 1-28: Letrozole 2.5mg orally once daily.

Repeat cycle every 4 weeks.

Letrozole + Lapatinib13,48,54

Days 1-28: Lapatinib 1,500mg orally once daily

Days 1-28: Letrozole 2.5mg orally once daily.

Repeat cycle every 4 weeks.

Letrozole + Lapatinib + Trastuzumab13,47-49

Days 1-28: Letrozole 2.5mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzmab 4mg/kg IV over 90 minutes on week 1, then 2mg/m2 IV starting week 2 cycled weekly.

OR

Days 1-28: Letrozole 2.5mg orally once daily

Days 1-28: Lapatinib 1,000mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV 90 minutes on cycle 1, then 6mg/m2 IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Letrozole + Trastuzumab13,49,50

Days 1-28: Letrozole 2.5mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting with week 2 cycled weekly.

OR

Days 1-28: Letrozole 2.5mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg over 30 minutes starting with cycle 2 cycled every 3 weeks.

Tamoxifen21,35,55

Day 1-28: Tamoxifen 20mg orally once daily.

Repeat cycle every 4 weeks.

Tamoxifen + Trastuzmab21,49,50

Days 1-28: Tamoxifen 20mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting with week 2 cycled weekly.

OR

Days 1-28: Tamoxifen 20mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg over 30 minutes starting with cycle 2 cycled every 3 weeks.

Chemotherapy Regimens For Recurrent or Stage IV (M1) Disease1,a,i

HER2-Negative

Preferred Regimens

Atezolizumab + Albumin-Bound Paclitaxel (PD-L1-positive triple-negative breast cancer)56-58

Days 1 and 15: Atezolizumab 840mg IV over 60 minutes, followed by:

Days 1,8,15: Albumin-bound Paclitaxel 100mg/m2 IV.

Repeat cycle every 4 weeks.

Capecitabine59,60

Days 1-14: Capecitabine 1,000-1,250mg/m2 orally twice daily.

Repeat cycle every 3 weeks.

Carboplatin (triple-negative breast cancer and BRCA1/2 mutation)61

Day 1: Carboplatin AUC 6 IV over 30 minutes.

Repeat cycle every 3 or 4 weeks.

Cisplatin (triple-negative breast cancer and BRCA1/2 mutation)62

Day 1: Cisplatin 75mg/m2 IV over 60 minutes.

Repeat cycle every 3 weeks.

Doxorubicin63-66

Day 1: Doxorubicin 60-75mg/m2 IV push.

Repeat cycle every 3 weeks.

OR

Day 1: Doxorubicin 20mg/m2 IV push.

Repeat cycle weekly.

Eribulin67,68

Days 1 and 8: Eribulin 1.4mg/m2 IV push.

Repeat cycle every 3 weeks.

Gemcitabine69

Days 1,8,15: Gemcitabine 800-1,200mg/m2 IV over 30 minutes.

Repeat cycle every 4 weeks.

Liposomal Doxorubicin70,71

Day 1: Liposomal Doxorubicin 40-50mg/m2 IV.

Repeat cycle every 4 weeks.

Olaparib (germline BRCA1/2 mutation) (Category 1)72,73,k

Days 1-28: Olaparib 300mg orally twice daily.

Repeat cycle every 4 weeks.

Paclitaxel74,75

Day 1: Paclitaxel 175mg/m2 IV over 3 hours.

Repeat cycle every 3 weeks.

OR

Day 1: Paclitaxel 80mg/m2 IV over 60 minutes.

Repeat cycle weekly.

Talazoparib (germline BRCA1/2 mutation) (Category 1)76,77

Days 1-28: Talazoparib 1mg orally once daily.

Repeat cycle every 4 weeks.

Vinorelbine78

Day 1: Vinorelbine 25mg/m2 over 5-10 minutes.

Repeat cycle weekly.

Other Recommended Regimensj

Albumin-Bound Paclitaxel58,79,80

Day 1: Albumin-bound paclitaxel 260mg/m2 IV over 30 minutes.

Repeat cycle every 3 weeks.

OR

Days 1,8,15: Albumin-bound paclitaxel 100mg/m2 IV over 30 minutes.

Repeat cycle ever 4 weeks.

OR

Days 1,8,15: Albumin-bound paclitaxel 125mg/m2 IV over 30 minutes.

Repeat cycle every 4 weeks.

Cyclophosphamide81

Days 1-21: Cyclophosphamide 50mg orally once daily.

Repeat cycle every 4 weeks.

Docetaxel82,83

Day 1: Docetaxel 60-100mg/m2 IV over 60 minutes.

Repeat cycle every 3 weeks.

OR

Days 1,8,15,22,29,36: Docetaxel 35mg/m2 IV over 60 minutes.

Repeat cycle every 8 weeks (6 weeks on- followed by 2 weeks off-treatment)

Epirubicin84

Day 1: Epirubicin 60-90 mg/m2 IV push.

Repeat cycle every 3 weeks.

Ixabepilone85,86

Day 1: Ixabepilone 40mg/m2 (max 88mg) IV over 3 hours.

Repeat cycle every 3 weeks.

Useful in Certain Circumstancesj

AC87

Day 1: Doxorubicin 60mg/m2 IV push

Day 1: Cyclophosphamide 600mg/m2 IV over 30 minutes.

Repeat cycle every 3 weeks.

CMF88-90

Days 1-14: Cyclophosphamide 100mg/m2 orally once daily

Days 1 and 8: Methotrexate 40mg/m2 IV push

Days 1 and 8: Fluorouracil 600mg/m2 IV push.

Repeat every 4 weeks.

Docetaxel + Capecitabine91

Day 1: Docetaxel 75 mg/m2 IV over 60 minutes

Days 1-14: Capecitabine 950-1.250mg/m2 orally twice daily.

Repeat cycle every 3 weeks.

EC92,93

Day 1: Epirubicin 100mg/m2 IV push

Day 1: Cyclophosphamide 830mg/m2 IV over 30 minutes.

Repeat cycle every 3 weeks.

Gemcitabine + Carboplatin94

Days 1 and 8: Gemcitabine 1,000mg/m2 IV over 30 minutes

Days 1 and 8: Carboplatin AUC 2 IV over 30 minutes.

Repeat cycle every 3 weeks.

GT (Gemcitabine + Paclitaxel)95-

Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by:

Days 1 and 8: Gemcitabine 1,250mg/m2 IV over 30 minutes.

Repeat cycle every 3 weeks.

Paclitaxel + Bevacizumab96,97

Days 1,8,15: Paclitaxel 90mg/m2 IV over 60 minutes

Days 1 and 15: Bevacizumab 10mg/kg IV.

Repeat cycle every 4 weeks.

HER2-Positive44-46,g,l,m

Preferred Regimens

Pertuzumab + Trastuzumab49,98,99,m

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV overy 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

OR

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on cycle 1, followed by:

Days 8 and 15: Trastuzumab 2mg/kg IV over 30 minutes on cycle 1, followed by:

Days 1,8,15: Trastuzumab 2mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Pertuzumab + Trastuzumab + Docetaxel (Category 1)49,98,100

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2, followed by:

Day 1: Docetaxel 75mg/kg IV over 60 minutes on cycle 1, then 75-100mg/m2 over 60 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Pertuzumab + Trastuzumab + Paclitaxel49,98,101

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2

Days 1,8,15: Paclitaxel 80mg/kg IV over 60 minutes.

Repeat cycle every 3 weeks.

OR

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on cycle 1, followed by:

Days 8 and 15: Trastuzumab 2mg/kg IV over 30 minutes on cycle 1, followed by:

Days 1,8,15: Trastuzumab 2mg/kg IV over 30 minutes starting with cycle 2

Days 1,8,15: Paclitaxel 80mg/kg IV over 60 minutes.

Repeat cycle every 3 weeks.

OR

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2

Day 1: Paclitaxel 175mg/m2 IV over 3 hours.

Repeat cycle every 3 weeks.

OR

Day 1: Pertuzumab 840mg IV over 60 minutes on cycle 1, then 420mg IV over 30 minutes starting with cycle 2

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on cycle 1, followed by:

Days 8 and 15: Trastuzumab 2mg/kg IV over 30 minutes on cycle 1, followed by:

Days 1,8,15: Trastuzumab 2mg/kg IV over 30 minutes starting with cycle 2

Day 1: Paclitaxel 175mg/m2 IV over 3 hours.

Repeat cycle every 3 weeks.

Other Recommended Regimens

Ado-trastuzumab emtansine (Category 1)102-104

Day 1: Ado-trastuzumab emtansine 3.6mg/kg IV over 90 minutes on cycle 1, followed by:

Day 1: Ado-trastuzumab emtansine 3.6mg/kg over 30 minutes beginning with cycle 2.

Repeat cycle every 3 weeks.

Lapatinib + Capecitabine48,60,105

Days 1-21: Lapatinib 1,250mg orally once daily

Days 1-14: Capecitabine 1,000mg/m2 orally twice daily.

Repeat cycle every 3 weeks.

Trastuzumab + Albumin-bound Paclitaxel49,58,79,80,106

Day 1: Albumin-bound Paclitaxel 260mg/m2 IV over 30 minutes cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Albumin-bound Paclitaxel 260mg/m2 IV over 30 minutes.

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

OR

Days 1,8,15: Albumin-bound Paclitaxel 100 or 125mg/m2 cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 30 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1,8,15: Albumin-bound Paclitaxel 100 or 125 mg/m2 IV over 30 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes of cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Trastuzumab + Capecitabine49,60,107,198

Days 1-14: Capecitabine 1,000-1.250mg/m2 orally twice daily cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled every week.

OR

Days 1-14: Capecitabine 1,000-1,250mg/m2 orally twice daily

Day 1: Trastuzumab 8mg/kg IV over 90 minutes, then 6mg/kg IV over 30 minutes.

Repeat cycle every 3 weeks.

Trastuzumab + Carboplatin49,61,106

Day 1: Carboplatin AUC 6 IV over 30 minutes cycled every 3 or 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Carboplatin AUC 6 IV over 30 minutes cycled every 3 or 4 weeks, with:

Day 1: Tratuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV starting with cycle 2 cycled every 3 weeks.

Trastuzumab + Cisplatin49,62,106

Day 1: Cisplatin 75mg/m2 IV over 60 minutes cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Cisplatin 75mg/m2 IV over 60 minutes.

Day 1: Trastuzumab 8mg/kg IV over 90 minutes, then 6mg/kg IV over 30 minutes.

Repeat cycle every 3 weeks.

Trastuzumab + Cyclophosphamide49,106,109

Days 1-21: Cyclophosphamide 50mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1-21: Cyclophosphamide 50mg orally once daily cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Trastuzumab + Docetaxel49,110,111

Day 1: Docetaxel 80-100mg/m2 IV over 60 minutes cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/m2 IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Docetaxel 80-100 mg/m2 IV over 60 minutes.

Day 1: Trastuzumab 8mg/kg IV over 90 minutes with cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

OR

Days 1,8,15: Docetaxel 35mg/m2 IV over 60 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1,8,15: Docetaxel 35mg/m2 IV over 60 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2

cycled every 3 weeks.

Trastuzumab + Eribulin49,67,68,106

Days 1 and 8: Eribulin 1.4mg/m2 IV push cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/m2 IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1 and 8: Eribulin 1.4mg/m2 IV push.

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Trastuzumab + Gemcitabine49,69,106

Days 1,8,15: Gemcitabine 800-1,200mg/m2 IV over 30 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1,8,15: Gemcitabine 800-1,200mg/m2 IV over 30 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

Trastuzumab + Ixabepilone49,85,86,106

Day 1: Ixabepilone 40mg/m2 (maximum 88mg) IV over 3 hours cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Ixabepilone 40mg/m2 (maximum 88mg) IV over 3 hours cycled every 3 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Trastuzumab + Lapatinib (without cytotoxic therapy)48,49,112

Days 1-21: Lapatinib 1,000mg orally once daily cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1-21: Lapatinib 1,000mg orally once daily

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Trastuzumab + Paclitaxel49,106,113,114

Day 1: Paclitaxel 80-90mg/m2 IV over 60 minutes

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2.

Repeat cycle weekly.

OR

Day 1: Paclitaxel 80-90mg/m2 IV over 60 minutes cycled weekly, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6 mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

OR

Day 1: Paclitaxel 175mg/m2 IV over 3 hours cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Day 1: Paclitaxel 175mg/m2 IV over 3 hours

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

Trastuzumab + Paclitaxel + Carboplatin49,114-116

Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by:

Day 1: Carboplatin AUC 6 IV over 30 minutes cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV on week 1, then 2mg/kg over 30 minutes starting with week 2 cycled weekly.

OR

Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by:

Day 1: Carboplatin AUC 6 IV over 30 minutes, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV starting with cycle 2.

Repeat cycle every 3 weeks.

OR

Days 1,8,15: Paclitaxel 80mg/m2 IV over 60 minutes, followed by:

Days 1,8,15: Carboplatin AUC 2 IV over 30 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 4mg/kg IV on week 1, then 2mg/kg over 30 minutes starting with week 2 cycled weekly.

OR

Days 1,8,15: Paclitaxel 80mg/m2 IV over 60 minutes, followed by:

Days 1,8,15: Carboplatin AUC 2 IV over 30 minutes cycled every 4 weeks, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV starting with cycle 2 cycled every 3 weeks.

Trastuzumab + Vinorelbine49,117,118

Day 1: Vinorelbine 25mg/m2 IV over 5-10 minutes

Day 1: Trastuzumab 4mg/kg over 90 minutes on week 1, then 2mg/kg over 30 minutes starting with week 2.

Repeat cycle weekly.

OR

Day 1: Vinorelbine 25mg/m2 IV over 5-10 minutes cycled weekly, with:

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2 cycled every 3 weeks.

OR

Days 1 and 8: Vinorelbine 30-35 mg/m2 IV over 5-10 minutes cycled every 3 weeks, with:

Day 1: Trastuzumab 4mg/kg IV over 90 minutes on week 1, then 2mg/kg IV over 30 minutes starting week 2 cycled weekly.

OR

Days 1 and 8: Vinorelbine 30-35 mg/m2 IV over 5-10 minutes

Day 1: Trastuzumab 8mg/kg IV over 90 minutes on cycle 1, then 6mg/kg IV over 30 minutes starting with cycle 2.

Repeat cycle every 3 weeks.

a. The selection, dosing, and administration of anti-cancer agents and the management of associated toxicities are complex. Modifications of drug and schedule and initiation of supportive care interventions are often necessary because of expected toxicities and individual patient variability, prior treatment, and comorbidity. The optimal delivery of anti-cancer agnts therefore requires a health care delivery team experienced in the use of anti-cancer agents and the management of associated toxicities in patients with cancer.

b. Ovarian suppression for premenopausal women with hormone receptor-positive disease: Day 1: Goserelin 3.6mg subcutaneous every 4 weeks until endocrine therapy is completed or no longer required or Day 1: Leuprolide 3.75mg IM every 4 weeks until endocrine therapy is completed or no longer required.

c. CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) in combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) or fulvestrant may be considered as a treatment option for first-line therapy for women who are postmenopausal or premenopausal (receiving ovarian suppression or ablation with an LHRH agonist) with hormone-receptor positive, HER2-negative metastatic breast cancer. Fulvestrant has been combined with CDK4/6 inhibitors (ie, palbociclib, ribociclib) in the first-line setting in two randomized trials.

d. If there is disease progression while in CDK4/6 inhibitor therapy, there are no data to support an additional line of therapy with another CDK4/6-containing regimen. Likewise, if there is disease progression while on an everolimus-containing regimen, there are no data to support an additional line of therapy with another everolimus-containing regimen.

e. The safety of alpelisib in patients with Type 1 or uncontrolled Type II diabetes has not been established.

f. Indicated after progression on prior endocrine therapy and prior chemotherapy in the metastatic setting.

g. Trastuzumab and hyaluronidase-oysk injection (Day 1: Trastuzumab and hyaluronidase-oysk 600mg subcutaneous over 2-5 minutes every 3 weeks) for subcutaneous use may be substituted for trastuzumab. Do not substitute trastuzumab and hyaluronidase-oysk for or with ado-trastuzumab emtansine. An FDA-approved biosimilar is an appropriate substitute for trastuzumab.

h. If treatment was initated with chemotherapy and trastuzumab + pertuzumab, and the chemotherapy was stopped, endocrine therapy may be added to the trastuzumab + pertuzumab.

i. Albumin-bound paclitaxel may be substituted for paclitaxel or docetaxel due to medical necessity (ie, hypersensitivity reaction). If substituted for weekly paclitaxel or docetaxel, then the weekly dose of nab-paclitaxel shown not exceed 125mg/m2.

j. Sequential single agents are preferred, but chemotherapy combinations may be used in select patients with high tumor burden, rapidly progressive disease, and visceral crisis.

k. There is also a capsule formulation available. However, do not substitute the capsules for the tablets on a mg-per-mg basis due to differences in dosing and bioavailability.

l. Trastuzumab given in combination with an anthracycline is associated with significant cardiac toxicity. Concurrent use of trastuzumab and pertuzumab with an anthracycline should be avoided.

m. Patients previously treated with chemotherapy plus trastuzumab in the absence of pertuzumab in the metastatic setting may be considered for one line of therapy including both trastuzumab and pertuzumab in combination with or without cytotoxic therapy (such as vinorelbine or taxane). Further research is needed to determine the ideal sequencing strategy for anti-HER2 therapy.

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(Revised 10/2019) © 2019 by Haymarket Media, Inc.

Breast Cancer Drug Monographs

Breast Cancer

ABRAXANE AFINITOR ARIMIDEX
AROMASIN Cyclophosphamide CYTOXAN INJECTION
DELATESTRYL Doxorubicin HCl Doxorubicin HCl Solution
ELLENCE ESTRACE EVISTA
FARESTON FASLODEX FEMARA
Fluorouracil Fluoxymesterone GEMZAR
HALAVEN HERCEPTIN IBRANCE
IXEMPRA KADCYLA KISQALI
Megestrol acetate Methotrexate for injection Methotrexate injection
Pamidronate disodium Injection PERJETA PREMARIN
SOLTAMOX ORAL SOLUTION Tamoxifen TAXOL
TAXOTERE Thiotepa TREXALL
TYKERB Vinblastine for injection Vinblastine injection
XELODA ZOLADEX
Data provided by MPR.

This article originally appeared on Cancer Therapy Advisor