Breast Cancer (Recurrent or Metastatic) Treatment Regimens

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BREAST CANCER (RECURRENT OR METASTATIC)
TREATMENT REGIMENS

(Revised 5/2016)

© 2016 Haymarket Media, Inc.

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 breast cancer (recurrent or metastatic) treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These breast cancer (recurrent or metastatic) treatment regimens are only provided to supplement the latest treatment strategies.

These Cancer Treatment Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN 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 National Comprehensive Cancer Network 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.

Preferred Single Agents1

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

REGIMEN

DOSING

Doxorubicin2,3

Day 1: Doxorubicin 60–75mg/m2 IV.

Repeat cycle every 21 days.

or

Day 1: Doxorubicin 20mg/m2 IV.

Repeat cycle weekly.

Pegylated liposomal doxorubicin4

Day 1: Pegylated liposomal doxorubicin 50mg/m2 IV.

Repeat cycle every 28 days

Paclitaxel5,6

Day 1: Paclitaxel 175mg/m2 IV.

Repeat cycle every 21 days.

or

Day 1: 80mg/m2 IV.

Repeat cycle weekly.

Capecitabine7

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

Repeat cycle every 21 days.

Gemcitabine8

Days 1, 8, and 15: Gemcitabine 800–1,200mg/m2 IV.

Repeat cycle every 28 days.

Vinorelbine9

Day 1: Vinorelbine 25mg/m2 IV.

Repeat cycle weekly.

Eribulin10

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

Repeat cycle every 21 days.

Other Single Agents1

Cyclophosphamide11

Days 1–21: Cyclophosphamide 50mg orally daily.

Repeat cycle every 28 days.

Carboplatin12

Day 1: Carboplatin AUC 6mg min/mL IV.

Repeat cycle every 21–28 days.

Docetaxel13-15

Day 1: Docetaxel 60–100mg/m2 IV.

Repeat cycle every 21 days.

or

Day 1: Docetaxel 35mg/m2 IV.

Repeat cycle weekly for 6 weeks followed by a 2-week rest, then repeat.

Albumin-bound paclitaxel16,17

Days 1, 8, and 15: Albumin-bound paclitaxel 100mg/m2 or 125mg/m2 IV.

Repeat cycle every 28 days.

or

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

Repeat cycle every 21 days.

Cisplatin18

Day 1: Cisplatin 75mg/m2 IV.

Repeat cycle every 21 days.

Epirubicin19

Day 1: Epirubicin 60–90mg/m2 IV.

Repeat cycle every 21 days.

Ixabepilone20

Day 1: Ixabepilone 40mg/m2 IV.

Repeat cycle every 21 days.

Chemotherapy Combinations1

CAF21

Days 1–14: Cyclophosphamide 100mg/m2 orally

Days 1 and 8: Doxorubicin 30mg/m2 IV

Days 1 and 8: 5-fluorouracil 500mg/m2 IV.

Repeat cycle every 28 days.

FAC22

Days 1 and 8 OR 1 and 4: 5-fluorouracll 500mg/m2 IV

Day 1: Doxorubicin 50mg/m2 IV (or by 72-hour continuous infusion)

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days.

FEC23

Days 1 and 8: Cyclophosphamide 400mg/m2 IV

Days 1 and 8: Epirubicin 50mg/m2 IV

Days 1 and 8: 5-fluorouracil 500mg/m2 IV.

Repeat cycle every 28 days.

AC24

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days.

EC25

Day 1: Epirubicin 75mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days.

CMF26

Days 1–14: Cyclophosphamide 100mg/m2 orally

Days 1 and 8: Methotrexate 40mg/m2 IV

Days 1 and 8: 5-fluorouracll 600mg/m2 IV.

Repeat cycle every 28 days.

Docetaxel + capecitabine27

Day 1: Docetaxel 75mg/m2 IV

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

Repeat cycle every 21 days.

GT28

Day 1: Paclitaxel 175mg/m2 IV

Days 1 and 8: Gemcitabine 1,250mg/m2 IV (following paclitaxel on day 1).

Repeat cycle every 21 days.

Gemcitabine + carboplatin29

Days 1 and 8: Gemcitabine 1,000mg/m2

Days 1 and 8: Carboplatin AUC 2mg min/mL IV.

Repeat cycle every 21 days.

Paclitaxel + bevacizumab30

Days 1, 8, and 15: Paclitaxel 90mg/m2 by 1-hour IV

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

Repeat cycle every 28 days.

Preferred First-Line Agents for HER2-Positive Disease1

General treatment note: All trastuzumab-containing regimens require cardiac monitoring at baseline and at 3, 6, and 9 months.1

Pertuzumab + trastuzumab + docetaxel (Category 1)31

Day 1: Pertuzumab 840mg IV followed by 420mg IV

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV

Day 1: Docetaxel 75–100mg/m2 IV.

Repeat cycle every 21 days.

Pertuzumab + trastuzumab + paclitaxel32,33

Day 1: Pertuzumab 840mg IV followed by 420mg IV cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly OR trastuzumab 8mg/kg IV followed by 6mg/kg IV cycled every 21 days, plus

Day 1: Paclitaxel 80mg/m2 IV weekly OR paclitaxel 175mg/m2 cycled every 21 days.

Other First-Line Agents For HER2-Positlve Disease1

Ado-trastuzumab emtansine (T-DM1)34

Day 1: Ado-trastuzumab emtansine 3.6mg/kg IV.

Repeat cycle every 21 days.

Paclitaxel + carboplatin + trastuzumab33,35

Day 1: Carboplatin AUC 6mg min/mL IV

Day 1: Paclitaxel 175mg/m2 IV cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Weekly paclitaxel + carboplatin + trastuzumab33,36

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV plus carboplatin AUC 2mg min/mL cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Trastuzumab + paclitaxel 33,37,38

Day 1: Paclitaxel 175mg/m2 IV cycled every 21 days

OR

Day 1: Paclitaxel 80–90mg/m2 IV weekly, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Trastuzumab + docetaxel 33,39,40

Day 1: Docetaxel 80–100mg/m2 IV cycled every 21 days

OR

Days 1, 8, and 15: Docetaxel 35mg/m2 IV weekly, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Trastuzumab + vinorelbine33,41

Day 1: Vinorelbine 25mg/m2 IV weekly

OR

Days 1 and 8: Vinorelbine 30-35mg/m2 IV cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Trastuzumab + capecitabine33,42,43

Days 1–14: Capecitabine 1,000–1,250mg/m2 orally twice daily cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Agents for Trastuzumab-Exposed HER2-Positive Disease1

Lapatinib + capecitabine44

Days 1–21: Lapatinib 1,250mg orally daily

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

Repeat cycle every 21 days.

Trastuzumab + capecitabine33,37,43,45

Days 1–14: Capecitabine 1,000–1,250mg/m2 orally twice daily cycled every 21 days, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

Trastuzumab + lapatinib33,46

Lapatinib 1,000mg orally daily, plus

Day 1: Trastuzumab 4mg/kg IV followed by 2mg/kg IV weekly

OR

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV every 21 days.

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.2.2016. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed May 25, 2016.

2. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17(8):2341–2354.

3. Gasparini G, Dal Fior S, Panizzoni GA, Favretto S, Pozza F. Weekly epirubicin versus doxorubicin as second line therapy in advanced breast cancer. A randomized clinical trial. Am J Clin Oncol. 1991;14(1):38-44.

4. O'Brien ME, Wigler N, Inbar M, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCI (CAELYX/DoxiI) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004;15(3):440–449.

5. Seidman AD, Tiersten A, Hudis C, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995;13(10):2575–2581.

6. Perez EA, Vogel CL, Irwin DH, et al. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001;19(22):4216–4223.

7. Bajetta E, Procopio G, Celio L, et al. Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol. 2005;23(10):2155–2161.

8. Seidman AD. Gemcitabine as single-agent therapy in the management of advanced breast cancer. Oncology. (Williston Park) 2001;15(2 suppl 3):11–14.

9. Zelek L, Barthier S, Riofrio M, et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer. 2001;92(9):2267–2272.

10. Cortes J, O'Shaughnessy J, Loesch O, et al. Eribulin monotherapy versus treatment of physicians choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study. Lancet. 2011;377(9769):914–923.

11. Licchetta A, Correale P, Migali C, et al. Oral metronomic chemo- hormonal-therapy of metastatic breast cancer with cyclophosphamide and megestrol acetate. J Chemother. 2010;22(3):201–204.

12. Isakoff S J, Goss PE, Mayer EL, et al. TBCRCOO9: A multi-center phase II study of cisplatin or carboplatin for metastatic triple-negative breast cancer and evaluation of p631p73 as a biomarker of response [abstract). J Clin Oncol. 2011;29 (15_suppl): Abstract 1025.

13. Burris HA 3rd. Single-agent docetaxel (Taxotere) in randomized phase Ill trials. Semin Oncol. 1999;26(3 suppl 9):1–6.

14. Harvey V, Mouridsen H, Semiglazov V, et al: Phase Ill trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol. 2006;24(31):4963–4970.

15. Rivera E, Mejia JA, Arun BK, et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008;112(7):1455–1461.

16. Gradishar W, Tjulandin S. Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794–7803.

17. Gradishar W, Dimitry K, Sergey C, et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009;27(22):3611–3619.

18. Silver DR, Richardson AL, EkIund AC, et al. Efficacy of neoadjuvant cisplatin in triple-negative breast cancer. J Clin Oncol. 2010;28(7):1145–1153.

19. Bastholt L, Dalmark M, Gjedde SB, et al. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol. 1996;14(4):1146–1155.

20. Perez E, Lerzo G, Pivot X, et al. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007;25(23):3407–3414.

21. Bull JM, Tormey DC, Li SH, et al. A randomized comparative trial of adriamycin versus methotrexate in combination drug therapy. Cancer. 1978;41(5):1649–1657.

22. Hortobagyi GN, Gutterman JU, Blumenschein GR, et al. Combination chemoimmunotherapy of metastatic breast cancer with 5-fluorouracil, adriamycin, cyclophosphamide, and BCG. Cancer. 1979;43(4):1225–33.

23. Ackland SR, Anton A, Breithach GR, et al. Dose-intensive epirubicin-based chemotherapy is superior to an intensive intravenous cyclophosphamide, methotrexate, and fluorouracil regimen in metastatic breast cancer a randomized multinational study. J Clin Oncol. 2001;19(4):943–953.

24. Nabholtz JM, Falkson C, Campos O, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer results of a randomized, multicenter, phase Ill trial. J Clin Oncol. 2003;21(6):968–975.

25. Langley RE, Carmichel J, Jones AL, et al. Phase Ill trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer United Kingdom Cancer Research Institute. J Clin Oncol. 2005;23(33):8322–8330.

26. Bonadonna G, Brusamolino E, Valagussa P, et al. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med. 1976;294(8):405–410.

27. Mavroudis D, Papakotoulas P, Ardavanis A, et al; Breast Cancer Investigators of the Hellenic Oncology Research Group. Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer. Ann Oncol. 2010;21(1):48–54.

28. Albain KS, Nag S, Calderillo-Ruiz G, et al. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol. 2008;26(24):3950–3957.

29. O'Shaughnessy J, Schwartzberg LS, Danso MA, et al. A randomized phase ill study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (GIC) in metastatic triple-negative breast cancer (TNBC). [abstract]. J Clin Oncol. 2011; 29(Suppl_15):Abstract 1007.

30. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizurriab versus paclitaxel alone for metastatic breast cancer. N EngI J Med. 2007;357(26):2666–2676.

31. Baselga J, Cones J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N EngI J Med. 2012;366(2):109–119.

32. Datko F, D'Andrea G, Dickler M, et al. Phase II study of pertuzumab, trastuzumab, and weekly paclitaxel in patients with metastatic HER2-overexpressing metastatic breast cancer [abstract]. Cancer Research. 2012;72: Abstract P5-18–20.

33. Leyland-Jones B, Gelmon K, Ayoub JP, et al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J Clin Oncol. 2003;21(21):3965–3971.

34. Verma S, Miles O, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N EngI J Med. 2012;367(19):1783–1791.

35. Robert N, Leyland-Jones B, Asmar L, et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2006;24(18):2786–2792.

36. Perez EA, Suman VJ, Rowland KM, et al. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005;6(5):425–432.

37. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N EngI J Med. 2001;344(11):783–792.

38. Seidman A, Berry DA, Cirrincione C, et al. Randomized phase Ill trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008;26(10):1642–1649.

39. Marty M, Cognetti F, Maraninchi O, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005;23(19):4265–4274.

40. Esteva FJ, Valero V, Booser O, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2002;20(7):1800–1808.

41. Burstein HJ, Keshaviah A, Baron AD, et al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer the trastuzumab and vinorelbine or taxane study. Cancer. 2007;110(5):965–972.

42. von Minckwitz G, du Bois A, Schmidt M, et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer a German breast group 26/breast international group 03-05 study. J Clin Oncol. 2009;27(12):1999–2006.

43. Cobleigh MA, Vogel CL, Tripathy D, et al. Multinational study of the efficacy and safety of humanized anti-l-IER2 ruonodonal antibody in women who have HER2- overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol. 1999;17(9):2639–2648.

44. Geyer C, Forster J, Undquist O, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006:355(26):2733–2743.

45. Bartsch R, Wenzel C, Altorjai G, et al. Capecitabine and trastuzumab in heavily pretreated metastatic breast cancer. J Clin Oncol. 2007;25(25):3853–3858.

46. Blackwell KL, Burstein H, Storniolo AM, et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive. Trastuzumab-refractory metastatic breast cancer. J Clin Oncol. 2010;28(7):1124–1130.


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.

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