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Systemic Anti-Cancer Therapy Regimen Library

Home > BR Adjuvant - AC-TH [DOXOrubicin and CYCLOPHOSPHamide] Q3W followed by [DOCEtaxel and trastuzumab] Q3W

BR Adjuvant - AC-TH [DOXOrubicin and CYCLOPHOSPHamide] Q3W followed by [DOCEtaxel and trastuzumab] Q3W

Treatment Overview

This regimen consists of three parts: AC [DOXOrubicin and CYCLOPHOSPHamide] Q3W followed by TH [DOCEtaxel and trastuzumab] Q3W followed by single-agent trastuzumab.


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.

Cycles 1 to 4 - 21 days - AC [DOXOrubicin and CYCLOPHOSPHamide] Q3W

Cycle length:
21

Cycle specific Supportive Care Factors:

Emetogenicity: HIGH.

Cycle 5 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Loading Dose

Cycle length:
21

DOCEtaxel: Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

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


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: LOW.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 6 to 8 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Maintenance Dose

Cycle length:
21

DOCEtaxel: Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

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


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: LOW.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 9 to 21 - 21 days - trastuzumab Q3W Continuation

Cycle length:
21

trastuzumab:

  • Continues for a further 13 cycles, to give a total of one year’s treatment.
  • 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

Cycles 1 to 4 - 21 days - AC [DOXOrubicin and CYCLOPHOSPHamide] Q3W

Medication Dose Route Days Max Duration
olanzapine * 5 mg oral administration 1 to 4
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 12 mg oral administration 1
dexamethasone * 8 mg oral administration 2, 3, 4
ondansetron 8 mg oral administration 1
DOXOrubicin 60 mg/m² intravenous 1 15 minutes
CYCLOPHOSPHamide 600 mg/m² intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
cyclIZINE 50 mg Three times daily oral administration 1

Cycle specific Supportive Care Factors:

Emetogenicity: HIGH.

Cycle 5 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
DOCEtaxel * 100 mg/m² intravenous 1 60 minutes
trastuzumab 8 mg/kg intravenous 1 90 minutes
pegFILGRASTIM 6 mg subcutaneous injection 2
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

DOCEtaxel: Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

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


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: LOW.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 6 to 8 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
DOCEtaxel * 100 mg/m² intravenous 1 60 minutes
trastuzumab 6 mg/kg intravenous 1 90 minutes
pegFILGRASTIM 6 mg subcutaneous injection 2
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

DOCEtaxel: Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

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


Cycle specific Supportive Care Factors:

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment.

Emetogenicity: LOW.

Growth factor support: Recommended for primary prophylaxis.

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

Cycles 9 to 21 - 21 days - trastuzumab Q3W Continuation

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

trastuzumab:

  • Continues for a further 13 cycles, to give a total of one year’s treatment.
  • 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

Cycles 1 to 4 - 21 days - AC [DOXOrubicin and CYCLOPHOSPHamide] Q3W

Day: 1

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
  • Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 12 mg oral administration
Instructions:
ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
DOXOrubicin 60 mg/m² intravenous 15 minutes
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
CYCLOPHOSPHamide 600 mg/m² intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
cyclIZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
  • Note that domperidone is not recommended in combination with olanzapine and ondansetron due to potential risk of QT prolongation.

Day: 2

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
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 clinican's discretion.

Day: 3

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
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 clinican's discretion.

Day: 4

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinican's discretion.

Cycle 5 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Loading Dose

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
DOCEtaxel * 100 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set. 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.
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: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
pegFILGRASTIM 6 mg subcutaneous injection

Cycles 6 to 8 - 21 days - TH [DOCEtaxel and trastuzumab] Q3W Maintenance Dose

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
DOCEtaxel * 100 mg/m² intravenous 60 minutes
Instructions:
Prepare solution in PVC-free bag and administer via polyethylene lined administration set. 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.
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: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:
Take with food.
pegFILGRASTIM 6 mg subcutaneous injection

Cycles 9 to 21 - 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
Diarrhoea risk: Variable
Emetogenicity: Variable
Growth factor support: Variable
Hypersensitivity / Infusion related reaction risk: Variable

References

1. Slamon, D., W. Eiermann, N. Robert, et al. 2011. "Adjuvant trastuzumab in HER2-positive breast cancer." N Engl J Med 365(14):1273-1283., PMID: 21991949

2. Slamon D, Eirmann W, Robert N et al. 2006. “Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER2 positive early breast cancer patients: Second interim analysis (BCIRG006)” SABCS

3. Slamon, D., W. Eiermann, N. Robert, et al. 2015 "Ten year follow-up of BCIRG-006 comparing DOXOrubicin plus CYCLOPHOSPHamide followed by DOCEtaxel (AC-T) with DOXOrubicin plus CYCLOPHOSPHamide followed by DOCEtaxel and trastuzumab (AC-TH) with DOCEtaxel, cARBOplatin, and trastuzumab (TCH) in HER2-positive early breast cancer" San Antonio Breast Cancer Symposium. Abstract S5-04. Presented December 11, 2015

4. Pfizer New Zealand Limited. DBL Docetaxel New Zealand Data Sheet 07 August 2020. https://www.medsafe.govt.nz/profs/Datasheet/d/dbldocetaxelinj.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. 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

7. 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

8. 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.