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Systemic Anti-Cancer Therapy Regimen Library

BR Neoadjuvant - CARBOplatin, PACLItaxel, pERTUZumab and trastuzumab

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 - pERTUZumab and trastuzumab Loading Doses

Cycle length:
21

pERTUZumab: An observation period of 60 minutes post-infusion is recommended prior to administration of further systemic anti-cancer treatment.


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

Cycle 2 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (tapering PACLItaxel hypersensitivity pre-medication)

Cycle length:
21

pERTUZumab:

  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.

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


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

Cycles 3 to 9 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (no hypersensitivity pre-medications)

Cycle length:
21

pERTUZumab:

  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.

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


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

Cycle details

Cycle 1 - 21 days - pERTUZumab and trastuzumab Loading Doses

Medication Dose Route Days Max Duration
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1
loratadine * 10 mg oral administration 1, 8
famotidine * 20 mg oral administration 1, 8
dexamethasone * 4 mg oral administration 8
pERTUZumab 840 mg intravenous 1 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8 60 minutes
cARBOplatin * 6 AUC (area under the curve) intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
filgrastim 5 microgram/kg Once daily subcutaneous injection 2 to 6
domperidone 10 mg Three times daily oral administration 1

pERTUZumab: An observation period of 60 minutes post-infusion is recommended prior to administration of further systemic anti-cancer treatment.


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

Cycle 2 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (tapering PACLItaxel hypersensitivity pre-medication)

Medication Dose Route Days Max Duration
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 8 mg oral administration 1, 2, 3
loratadine * 10 mg oral administration 1, 8
famotidine * 20 mg oral administration 1
ondansetron 8 mg oral administration 1, 8
pERTUZumab 420 mg intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8 60 minutes
cARBOplatin * 6 AUC (area under the curve) intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
filgrastim 5 microgram/kg Once daily subcutaneous injection 2 to 6
domperidone 10 mg Three times daily oral administration 1

pERTUZumab:

  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.

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


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

Cycles 3 to 9 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (no hypersensitivity pre-medications)

Medication Dose Route Days Max Duration
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1, 8
pERTUZumab 420 mg intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8 60 minutes
cARBOplatin * 6 AUC (area under the curve) intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
filgrastim 5 microgram/kg Once daily subcutaneous injection 2 to 6
domperidone 10 mg Three times daily oral administration 1

pERTUZumab:

  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.

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


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

Full details

Cycle 1 - 21 days - pERTUZumab and trastuzumab Loading Doses

Day: 1

Medication Dose Route Max duration Details
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food. 

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.


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.
pERTUZumab 840 mg intravenous 60 minutes
Instructions:

An observation period of 60 minutes post-infusion is recommended prior to administration of further systemic anti-cancer treatment.

trastuzumab 8 mg/kg intravenous 90 minutes
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.
cARBOplatin * 6 AUC (area under the curve) intravenous 60 minutes
Instructions:
Hypersensitivity risk increases with number of cycles of cARBOplatin.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.


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: 2

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 3

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 4

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 6

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

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.

Cycle 2 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (tapering PACLItaxel hypersensitivity pre-medication)

Day: 1

Medication Dose Route Max duration Details
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy 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.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy


pERTUZumab 420 mg intravenous 60 minutes
Instructions:
  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.
trastuzumab 6 mg/kg intravenous 90 minutes
Instructions:

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

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.
cARBOplatin * 6 AUC (area under the curve) intravenous 60 minutes
Instructions:
Hypersensitivity risk increases with number of cycles of cARBOplatin.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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: 2

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 3

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 4

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 6

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 8

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.

Cycles 3 to 9 - 21 days - pERTUZumab and trastuzumab Maintenance Doses (no hypersensitivity pre-medications)

Day: 1

Medication Dose Route Max duration Details
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.


pERTUZumab 420 mg intravenous 60 minutes
Instructions:
  • If the initial loading dose is well tolerated, subsequent doses may be administered over 30 minutes.
  • An observation period of 30 minutes (or 60 minutes if previous reaction) post-infusion is recommended prior to administration of further systemic anti-cancer treatment.
trastuzumab 6 mg/kg intravenous 90 minutes
Instructions:

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

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.
cARBOplatin * 6 AUC (area under the curve) intravenous 60 minutes
Instructions:
Hypersensitivity risk increases with number of cycles of cARBOplatin.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.


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: 2

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 3

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 4

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 6

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 8

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

ONE hour before 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.

Supportive Care Factors

Factor Value
Emetogenicity: Variable
Growth factor support: Recommended for primary prophylaxis
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

Emetogenicity: HIGH (cARBOplatin AUC≥4) day 1; LOW day 8.

References

van der Voort A, van Ramshorst MS, van Werkhoven ED et al. Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 randomized, Phase 3 Trial. JAMA Oncol. 2021 Jul 1;7(7):978-984. doi: 10.1001/jamaoncol.2021.1371., PMID: 34014249

van Ramshorst MS et al. Dutch Breast Cancer Research Group (BOOG). Toxicity of dual HER2- blockade with pertuzumab added to anthracycline versus non-anthracycline containing chemotherapy as neoadjuvant treatment in HER2-positive breast cancer: The TRAIN-2 study. Breast. 2016 Oct;29:153-9. doi: 10.1016/j.breast.2016.07.017. Epub 2016 Aug 5., PMID: 27498129

van Ramshorst MS et al. Dutch Breast Cancer Research Group (BOOG). Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2- positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1630-1640. doi: 10.1016/S1470-2045(18)30570-9. Epub 2018 Nov 6., PMID: 30413379

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)

Roche Products (New Zealand) Limited. Perjeta (pertuzumab) New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/p/perjetainf.pdf (Accessed 12 April 2021)

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)

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

Rogers, E. S., E. Witton, J. Stewart, and D. Porter. "Efficacy and safety of a single dose of dexamethasone pre docetaxel treatment: The Auckland experience." Annals of Oncology 25 (2014): iv537.

Chouhan JD, Herrington JD. Single premedication dose of dexamethasone 20 mg IV before docetaxel administration. J Oncol Pharm Pract. 2011 Sep;17(3):155-9. doi: 10.1177/1078155210367950. Epub 2010 May 6., PMID: 20447949

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

Lyman GH, Balaban E, Diaz M, et al. 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.