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Systemic Anti-Cancer Therapy Regimen Library

Home > BR Metastatic - PACLItaxel Q1W, pERTUZumab and trastuzumab Q3W

BR Metastatic - PACLItaxel Q1W, pERTUZumab and trastuzumab Q3W

Treatment Overview

PERTUZumab and trastuzumab may continue after PACLItaxel has been discontinued until disease progression or toxicity.


This regimen contains a biological anti-cancer medicine where one or more biosimilars may exist. These have been reviewed by the regulator (Medsafe) and by haematologists and/or oncologists nationally. Where haematologists and/or oncologists 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. If a prescriber thinks there is a difference, then a specific brand will be named when prescribing.

Cycle 1 - 21 days - Loading Dose

Cycle length:
21

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Cycle length:
21

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

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

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Cycle details

Cycle 1 - 21 days - Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
pERTUZumab * 840 mg intravenous 1 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
famotidine * 20 mg oral administration 1, 8, 15
pERTUZumab * 420 mg intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
PACLItaxel * 80 mg/m² intravenous 1, 8, 15 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

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

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

If the initial infusion of PACLItaxel is well tolerated, the clinician may decide at their discretion to taper off and eventually omit dexamethasone premedication. If dexamethasone is omitted, the clinician may consider ondansetron 8 mg ONE hour prior to PACLItaxel infusion for antiemetic cover.

Full details

Cycle 1 - 21 days - 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.
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.
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.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 8

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.

Day: 15

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.

Cycle 2 (and all further cycles) - 21 days - Maintenance 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.
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 of trastuzumab 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.
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.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 8

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.

Day: 15

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.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Low
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

References

1. Dang, C., N. Iyengar, F. Datko, et al. 2015. "Phase II study of paclitaxel given once per week along with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer." J Clin Oncol 33(5):442-447, PMID: 25547504

2. Bachelot, T., E. Ciruelos, T. Peretz-Yablonski, et al. 2014. "First-line pertuzumab (P), trastuzumab (H), and taxane therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC): Interim safety results (N=704) from PERUSE." ASCO Meeting Abstracts 32(15_suppl):548

3. Baselga, J., J. Cortes, S. B. Kim, et al. 2012. "Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer." N Engl J Med 366(2):109-119., PMID: 22149875

4. 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)

5. 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)

6. 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)

7. 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

8. 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

9. 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.