HER2-positive breast cancer

Active Ingredient: Pertuzumab

Indication for Pertuzumab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Early breast cancer

Pertuzumab is indicated for use in combination with trastuzumab and chemotherapy in:

  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
  • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

Metastatic breast cancer

Pertuzumab is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

For this indication, competent medicine agencies globally authorize below treatments:

840 mg initial loading dose and 420 mg maintenance dose every 3 weeks

For:

Dosage regimens

Intravenous, 840 milligrams pertuzumab, one dose, over the duration of 3 weeks. Afterwards, intravenous, 420 milligrams pertuzumab, once every 3 weeks.

Detailed description

The recommended initial loading dose of pertuzumab is 840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes. An observation period of 30-60 minutes is recommended after completion of each infusion. The observation period should be completed prior to any subsequent infusion of trastuzumab or chemotherapy.

Metastatic breast cancer

Pertuzumab should be administered in combination with trastuzumab and docetaxel. Treatment with pertuzumab and trastuzumab may continue until disease progression or unmanageable toxicity even if treatment with docetaxel is discontinued.

Early breast cancer

In the neoadjuvant setting, pertuzumab should be administered for 3 to 6 cycles in combination with trastuzumab and chemotherapy, as part of a complete treatment regimen for early breast cancer.

In the adjuvant setting, pertuzumab should be administered in combination with trastuzumab for a total of one year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first) as part of a complete regimen for early breast cancer and regardless of the timing of surgery. Treatment should include standard anthracycline- and/or taxane-based chemotherapy. Pertuzumab and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.

Delayed or missed doses

For recommendations on delayed or missed doses, please refer to the table below.

Recommendations regarding delayed or missed doses:

Time between two sequential infusionspertuzumabtrastuzumab
IVSC
<6 weeksThe 420 mg dose of pertuzumab should be administered as soon as possible. Do not wait until the next planned dose. Thereafter, revert to the original planned schedule.The 6 mg/kg dose of trastuzumab IV should be administered as soon as possible. Do not wait until the next planned dose. Thereafter, revert to the original planned schedule.The fixed dose of 600mg trastuzumab SC should be administered as soon as possible. Do not wait until the next planned dose.
≥6 weeksThe 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.The loading dose of 8 mg/kg of trastuzumab IV should be re-administered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter.

Dosage considerations

For the initial dose, the recommended infusion period is 60 minutes. If the first infusion is well tolerated, subsequent infusions may be administered over a period of 30 minutes to 60 minutes.

Active ingredient

Pertuzumab

Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K). Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively.

Read more about Pertuzumab

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