Breast Cancer (Invasive) Treatment Regimens

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BREAST CANCER (INVASIVE) 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 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 Regimens for HER2-negative Disease1

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

REGIMEN

DOSING

Dose-dense AC followed by paclitaxel

(Category 1)2

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles, followed by:

Day 1: Paclitaxel 175mg/m2 via 3-hour IV infusion.

Repeat cycle every 14 days for 4 cycles. (All cycles are with filgrastim support)

Dose-dense AC followed by weekly paclitaxel (Category 1)2

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles, followed by:

Day 1: Paclitaxel 80mg/m2 via 1-hour IV infusion weekly for 12 weeks.

TC (Category 1)3

Day 1: Docetaxel 75mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles. (All cycles are with filgrastim support)

Other Regimens for HER2-negative Disease1

AC (Category 1)4

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

TAC (Category 1)5

Day 1: Docetaxel 75mg/m2 IV

Day 1: Doxorubicin 50mg/m2 IV day

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days for 6 cycles. (All cycles are with filgrastim support)

FAC (Category 1)6,7

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

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

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days for 6 cycles.

CAF (Category 1)8

Days 1–14: Cyclophosphamide 100mg/m2 PO

Days 1 and 8: Doxorubicin 30mg/m2 IV

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

Repeat cycle every 28 days for 6 cycles.

CEF (Category 1)9

Days 1–14: Cyclophosphamide 75mg/m2 PO

Days 1 and 8: Epirubicin 60mg/m2 IV

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

With cotrimoxazole support. Repeat cycle every 28 days for 6 cycles.

CMF (Category 1)10

Days 1–14: Cyclophosphamide 100mg/m2 PO

Days 1 and 8: Methotrexate 40mg/m2 IV

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

Repeat cycle every 28 days for 6 cycles.

AC followed by docetaxel (Category 1)11

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Docetaxel 100mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

AC followed by weekly paclitaxel (Category 1)11

Day 1: Doxorubicin 60mg/m IV

Day 1: Cyclophosphamide 600mg/m IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Paclitaxel 80mg/m by 1-hour IV infusion weekly for 12 weeks.

EC (Category 1)12

Day 1: Epirubicin 100mg/m2 IV

Day 1: Cyclophosphamide 830mg/m2 IV.

Repeat cycle every 21 days for 8 cycles.

FEC followed by docetaxel (Category 1)13

Day 1: 5-fluorouracil 500mg/m2 IV

Day 1: Epirubicin 100mg/m2 IV

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

Day 1: Docetaxel 100mg/m2 IV.

Repeat cycle every 21 days for 3 cycles.

FEC followed by weekly paclitaxel (Category 1)14

Day 1: 5-fluorouracil 600mg/m2 IV

Day 1: Epirubicin 90mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

3 weeks of no treatment, followed by:

Paclitaxel 100mg/m2 IV infusion weekly for 8 weeks.

FAC followed by weekly paclitaxel (Category 1)

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

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

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days for 6 cycles, followed by:

Paclitaxel 80mg/m2 via 1-hour IV infusion weekly for 12 weeks.

Preferred Regimens for HER2-positive Disease1

AC followed by paclitaxel with trastuzumab15

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Paclitaxel 80mg/m2 via 1-hour IV infusion weekly for 12 weeks, with:

Trastuzumab 4mg/kg IV with first dose of paclitaxel, followed by:

Trastuzumab 2mg/kg IV weekly to complete 1 year of treatment.

As an alternative, trastuzumab 6mg/kg IV every 21 days may be used following the completion of paclitaxel, and given to complete 1 year of trastuzumab treatment. Cardiac monitoring at baseline, 3, 6, and 9 months.

AC followed by paclitaxel with trastuzumab + pertuzumab

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

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

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

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

Dose-dense AC followed by paclitaxel with trastuzumab16

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles, followed by:

Day 1: Paclitaxel 175mg/m2 via 3-hour IV infusion (All cycles are with filgrastim support).

Repeat cycle every 14 days for 4 cycles, plus:

Trastuzumab 4mg/kg IV with first dose of paclitaxel, followed by:

Trastuzumab 2mg/kg IV weekly to complete 1 year of treatment.

As an alternative, trastuzumab 6mg/kg IV every 21 days may be used following the completion of paclitaxel, and given to complete 1 year of trastuzumab treatment. Cardiac monitoring at baseline, 3, 6, and 9 months.

TCH17

Day 1: Docetaxel 75mg/m2 IV

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

Repeat cycle every 21 days for 6 cycles, with:

Day 1: Trastuzumab 4mg/kg IV week 1, followed by 2mg/kg IV for 17 weeks, followed by:

Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

TCH chemotherapy + pertuzumab18

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

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

Day 1: Docetaxel 75mg/m2 IV

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

Repeat cycle every 21 days for 6 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

Other Regimens for HER2-positive Disease1

AC followed by docetaxel with trastuzumab17

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Docetaxel 100mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, with:

Trastuzumab 4mg/kg IV week 1, followed by 2mg/kg IV weekly for 11 weeks, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

AC followed by docetaxel with trastuzumab and pertuzumab18

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

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 for 4 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

FEC followed by pertuzumab + trastuzumab + docetaxel18

Day 1: Fluorouracil 500mg/m2 IV

Day 1: Epirubicin 100mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

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 for 3 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

FEC followed by pertuzumab + trastuzumab + paclitaxel18

Day 1: Fluorouracil 500mg/m2 IV

Day 1: Epirubicin 100mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

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

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

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

Pertuzumab + trastuzumab + docetaxel followed by FEC19

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 for 4 cycles, followed by adjuvant therapy:

Day 1: Fluorouracil 600mg/m2 IV

Day 1: Epirubicin 90mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV. Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

Pertuzumab + trastuzumab + paclitaxel followed by FEC19

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

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

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by adjuvant therapy:

Day 1: Fluorouracil 600mg/m2 IV

Day 1: Epirubicin 90mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 3 cycles, followed by:

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy. Cardiac monitoring at baseline, 3, 6, and 9 months.

Paclitaxel + trastuzumab20

Day 1: Paclitaxel 80mg/m2 IV weekly for 12 weeks, plus

Trastuzumab 4mg/kg IV with first dose of paclitaxel, followed by:

Day 1: Trastuzumab 2mg/kg IV weekly OR 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of treatment.

Cardiac monitoring at baseline, 3, 6, and 9 months.

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2014. Available at: http://www.nccn.org. Accessed October 9, 2014.

2. Citron ML, Berry DA, Cirrincione C, et al: Randomized Trial of Dose-Dense Versus Conventionally Scheduled and Sequential Versus Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer: First Report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003;21:1431–1439.

3. Jones S, Holmes F, O'Shaughnessey J, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research trial 9735. J. Clin Oncol. 2009;27:1177–1183.

4. Fisher B, Brown AM, Dimitrov NV, et al: Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with six months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: Results from NSABP B-15. J Clin Oncol. 1990;8:1483–1496.

5. Martin. Pienkowski T, Mackey J, et al: Adjuvant docetaxel for node-positive breast cancer. N Engl J. Med. 2005;352:22.

6. Buzdar AU, Kau SW, Smith TL, Hortobagyi GN. Ten-year results of FAC adjuvant chemotherapy trial in breast cancer. Am J Clin Oncol. 1989;12:123–128.

7. Assikis V, Buzdar A, Yang Y, et al: A phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma: final analysis with 10-year follow-up. Cancer. 2003;97:2716–2723.

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

9. Levine MN, Bramwell VH, Pritchard KI, et al: Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer institute of Canada Clinical Trials Group. J Clin Oncol. 1998;16:2651–2658.

10. Goldrhirsch A, Colleoni M, Coates AS, et al: Adding adjuvant CMF chemotherapy to either radiotherapy or tamoxifen: are all CMFs alike? The International Breast Cancer Study Group (IBCSG). Ann Oncol. 1998;9:489–493.

11. Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in adjuvant treatment of breast cancer. N Engl J Med. 2008;258:16631671.

12. Piccart MJ, Di Leo A, Beauduin M, et al: Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer. J Clin Oncol. 2001;19:3103–3110.

13. Roche H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: The FNCLCC PACS 001 trial. J Clin Oncol. 2006;24:5664–5671.

14. Martin M, Rodriguez-Lescure A, Ruiz A, et al: Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel for early breast cancer. J Nati Cancer Inst. 2008;100:805–814.

15. Romond EH, Perez EZ, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2 positive breast cancer.
N Engl J Med.
2005;353:1673–1684.

16. Dang C, Fornier M, Sugarman S, et al: The Safety of Dose-Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Trastuzumab in HER-2/neu Overexpressed/ Amplified Breast Cancer. J. Clin Oncol. 2008;26(8): 1216–1222.

17. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273–1283.

18. Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline—containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278–2284.

19. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomized multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25–32.

20. Tolaney S, Barry W, Dang C, et al. A phase II study of paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). [abstract]. San Antonio Breast Cancer Symposium 2013; Abstract S1–04.

(Revised 10/2014)

© 2014 Haymarket Media, Inc.

 


Breast Cancer Drug Monographs

Breast Cancer

Abraxane Adriamycin Adriamycin Solution
Adrucil Aredia Arimidex
Aromasin Ellence Estrace
Evista Fareston Faslodex
Femara Gemzar Halaven
Herceptin Ixempra Megace
Methotrexate for Injection Methotrexate Injection Soltamox Oral Solution
Taxol Trexall Tykerb
Vinblastine for Injection Vinblastine Injection Xeloda
Zoladex Zoladex 3-Month 10.8mg

Data provided by the Monthly Prescribing Reference (MPR) Hematology/Oncology Edition.
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