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Systemic Anti-Cancer Therapy Regimen Library

Home > BR Metastatic - vinORELBine [oral], pERTUZumab and trastuzumab Q3W

BR Metastatic - vinORELBine [oral], pERTUZumab and trastuzumab Q3W

Treatment Overview

pERTUZumab and trastuzumab may continue after vinORELBine has been discontinued until disease progression or toxicity.


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.

Cycle 2 (and all further cycles) - 21 days - pERTUZumab and trastuzumab Maintenance Doses

Cycle length:
21

pERTUZumab:

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

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


vinORELBine: If well tolerated, consider increasing dose of oral vinORELBine to 80 mg/m2 from Cycle 2 or 3.

Cycle details

Cycle 1 - 21 days - pERTUZumab and trastuzumab Loading Doses

Medication Dose Route Days Max Duration
pERTUZumab * 840 mg intravenous 1 60 minutes
trastuzumab * 8 mg/kg intravenous 1 90 minutes
ondansetron 8 mg oral administration 1, 8
vinORELBine 60 mg/m² oral administration 1, 8
ondansetron 8 mg oral administration 1, 8
domperidone 10 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

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

Cycle 2 (and all further cycles) - 21 days - pERTUZumab and trastuzumab Maintenance Doses

Medication Dose Route Days Max Duration
pERTUZumab * 420 mg intravenous 1 60 minutes
trastuzumab * 6 mg/kg intravenous 1 90 minutes
ondansetron 8 mg oral administration 1, 8
vinORELBine 60 mg/m² oral administration 1, 8
ondansetron 8 mg oral administration 1, 8
domperidone 10 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

pERTUZumab:

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

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


vinORELBine: If well tolerated, consider increasing dose of oral vinORELBine to 80 mg/m2 from Cycle 2 or 3.

Full details

Cycle 1 - 21 days - pERTUZumab and trastuzumab Loading Doses

Day: 1

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

ONE hour prior to chemotherapy.
vinORELBine 60 mg/m² oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew.
  • KEEP IN FRIDGE - DO NOT FREEZE.
  • Round dose to closest multiple of 20 mg, 30 mg and/or 80 mg capsules.
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.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:

At night when required for constipation.

  • Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

Day: 8

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

ONE hour prior to chemotherapy.
vinORELBine 60 mg/m² oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew.
  • KEEP IN FRIDGE - DO NOT FREEZE.
  • Round dose to closest multiple of 20 mg, 30 mg and/or 80 mg capsules.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Cycle 2 (and all further cycles) - 21 days - pERTUZumab and trastuzumab Maintenance Doses

Day: 1

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

ONE hour prior to chemotherapy. 
vinORELBine 60 mg/m² oral administration
Instructions:
  • If well tolerated, consider increasing dose to 80 mg/m2 from Cycle 2 or 3.
  • Take with food. Swallow whole with a glass of water, do not crush, chew.
  • KEEP IN FRIDGE - DO NOT FREEZE.
  • Round dose to closest multiple of 20 mg, 30 mg and/or 80 mg capsules.
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.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:

At night when required for constipation.

  • Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

Day: 8

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

ONE hour prior to chemotherapy. 
vinORELBine 60 mg/m² oral administration
Instructions:
  • If well tolerated, consider increasing dose to 80 mg/m2 from Cycle 2 or 3.
  • Take with food. Swallow whole with a glass of water, do not crush, chew.
  • KEEP IN FRIDGE - DO NOT FREEZE.
  • Round dose to closest multiple of 20 mg, 30 mg and/or 80 mg capsules.
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Supportive Care Factors

Factor Value
Constipation risk: laxatives are usually prescribed
Emetogenicity: Medium to high


References

Perez, E.A., López-Vega, J.M., Petit, T. et al. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res 18, 126 (2016). https://doi.org/10.1186/s13058-016-0773-6, PMID: 27955684

Farhat, F., J. G. Kattan and M. Ghosn. 2016. "Oral vinorelbine in combination with trastuzumab as a first-line therapy of metastatic or locally advanced HER2-positive breast cancer." Cancer Chemother Pharmacol 77(5):1069-1077., PMID: 27059339

Jassem, J., R. Ramlau, H. Karnicka-Mlodkowska, et al. 2001. "A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients." Ann.Oncol. 12(10):1375-1381., PMID: 11762807

Wargin, W. A. and V. S. Lucas. 1994. "The clinical pharmacokinetics of vinorelbine (Navelbine)." Semin Oncol 21(5 Suppl 10):21-27., PMID: 7973765

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)

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)

Te Arai BioFarma Limited. Vinorelbine Te Arai (vinorelbine) New Zealand Data Sheet 18 March 2021. https://www.medsafe.govt.nz/profs/datasheet/v/vinorelbineTeAraicap.pdf (Accessed 30 May 2024).

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, 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

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.