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Home > BR Adjuvant - PACLItaxel Q1W and trastuzumab Q3W

BR Adjuvant - PACLItaxel Q1W and trastuzumab Q3W

Treatment Overview

This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycle 1 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Loading Dose

Cycle length:
21

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycle 2 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Cycle length:
21

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 3 to 4 - 21 days - PACLItaxel Q1W (no hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Cycle length:
21

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Cycles 5 to 17 - 21 days - Trastuzumab Q3W Continuation

Cycle length:
21

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: MINIMAL.

Cycle details

Cycle 1 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
dexamethasone * 4 mg oral administration 8
ondansetron 8 mg oral administration 15
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
domperidone 10 mg Three times daily oral administration 1

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycle 2 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Medication Dose Route Days Max Duration
loratadine * 10 mg oral administration 1
ondansetron 8 mg oral administration 1, 8, 15
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
domperidone 10 mg Three times daily oral administration 1

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Hypersensitivity / Infusion related reaction risk: HIGH - routine premedication recommended.

Cycles 3 to 4 - 21 days - PACLItaxel Q1W (no hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Medication Dose Route Days Max Duration
ondansetron 8 mg oral administration 1, 8, 15
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
domperidone 10 mg Three times daily oral administration 1

PACLItaxel: Tapering schedule of pre-medications is for patients who did not experience a hypersensitivity reaction to the previous dose of weekly PACLItaxel.

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: LOW.

Cycles 5 to 17 - 21 days - Trastuzumab Q3W Continuation

Medication Dose Route Days Max Duration
trastuzumab 6 mg/kg intravenous 1 90 minutes

trastuzumab: If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.


Cycle specific Supportive Care Factors:

Emetogenicity: MINIMAL.

Full details

Cycle 1 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Loading Dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:

ONE hour prior to PACLItaxel infusion.

Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.
trastuzumab 8 mg/kg intravenous 90 minutes
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

Day: 8

Medication Dose Route Max duration Details
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:

ONE hour prior to PACLItaxel infusion.

Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
dexamethasone * 4 mg oral administration
Instructions:

ONE hour prior to PACLItaxel infusion with food.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Day: 15

Medication Dose Route Max duration Details
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
famotidine * 20 mg oral administration
Instructions:

ONE hour prior to PACLItaxel infusion.

Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Cycle 2 - 21 days - PACLItaxel Q1W (tapering hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Day: 1

Medication Dose Route Max duration Details
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to PACLItaxel infusion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.
trastuzumab 6 mg/kg intravenous 90 minutes
Instructions:

If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

Day: 8

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Day: 15

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Cycles 3 to 4 - 21 days - PACLItaxel Q1W (no hypersensitivity pre-medications) and trastuzumab Q3W Maintenance Dose

Day: 1

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.
trastuzumab 6 mg/kg intravenous 90 minutes
Instructions:

If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting. The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

Day: 8

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Day: 15

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.
PACLItaxel * 80 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.

Please carry out graded challenge as per institutional policy.

Cycles 5 to 17 - 21 days - Trastuzumab Q3W Continuation

Day: 1

Medication Dose Route Max duration Details
trastuzumab 6 mg/kg intravenous 90 minutes
Instructions:

If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.

Supportive Care Factors

Factor Value
Emetogenicity: Variable
Hypersensitivity / Infusion related reaction risk: Variable

References

1. Perez, E. A., E. H. Romond, V. J. Suman, et al. 2011. "Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31." J Clin Oncol 29(25):3366-3373, PMID: 21768458

2. Romond, E. H., E. A. Perez, J. Bryant, et al. 2005. "Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer." N Engl J Med 353(16):1673-1684, PMID: 16236738

3. Tolaney, S. M., W.T. Barry, C.T. Dang, et al. 2015. "Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer." N Engl J Med 372(2): 134-141, PMID: 25564897

4. Romond, E. H., J. H. Jeong, P. Rastogi, et al. 2012. "Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer." J Clin Oncol 30(31):3792-3799., PMID: 22987084

5. Perez, E. A., V. J. Suman, N. E. Davidson, et al. 2008. "Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial." J Clin Oncol 26(8):1231-1238, PMID: 18250349

6. Novartis New Zealand Ltd. PACLItaxel Ebewe New Zealand Data Sheet 16 April 2020. https://www.medsafe.govt.nz/profs/Datasheet/p/PACLItaxelEbeweinj.pdf (Accessed 26 November 2020)

7. Roche Products (New Zealand) Limited. Herceptin (trastuzumab) New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/h/Herceptininf.pdf (Accessed 16 February 2021)

8. Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641., PMID: 25089112

9. Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142. , PMID: 28848668

10. Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14. , PMID: 29443651

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.