SELECT NEOADJUVANT DOSING AND ADMINISTRATION


Patient selection

Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency.1

Neoadjuvant eligibility

To begin PERJETA and Herceptin® (trastuzumab)-based therapy in the neoadjuvant setting, patients must have HER2+ breast cancer with locally advanced, inflammatory, or early stage breast cancer (either node-positive or tumor size >2 cm).1

Please see the full Prescribing Information for complete dosing and administration, including dose considerations, dose modifications, preparation, storage, and handling. You can also download the PERJETA Dosing & Administration Guide.

LEARN ABOUT PERJETA DOSING & ADMINISTRATION

IN THE ADJUVANT SETTING

Patients who begin PERJETA and Herceptin in the neoadjuvant setting should continue to receive PERJETA and Herceptin every 3 weeks for a total of 1 year (up to 18 cycles), or until disease recurrence or unmanageable toxicity, whichever occurs first.1

*Or until disease recurrence or unmanageable toxicity, whichever comes first.

Recommended dosing

PERJETA and Herceptin are administered every 3 weeks1

PERJETA is a fixed dose, regardless of body weight. Administer 840 mg loading dose, 420 mg for subsequent cycles; Herceptin dosing: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles.

Dosing considerations

Dose sequencing1

  • PERJETA, Herceptin, and taxanes should be administered sequentially
    • PERJETA and Herceptin can be given in any order, and taxane should be administered after PERJETA and Herceptin 
  • In patients receiving an anthracycline-based regimen, PERJETA and Herceptin should be administered following completion of the anthracycline 
  • An observation period of 30 to 60 minutes is recommended after each PERJETA infusion and before commencement of any subsequent infusion of Herceptin or chemotherapy

If a delayed or missed dose of PERJETA occurs1

Dose interruption or discontinuation of treatment1

  • PERJETA should be discontinued if Herceptin treatment is discontinued 
  • Dose reductions are not recommended for PERJETA 
  • For chemotherapy dose modifications, see their respective prescribing information 
  • If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies
    • The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction

Neoadjuvant chemotherapy regimens1

  • 4 preoperative cycles of PERJETA in combination with Herceptin and docetaxel, followed by 3 postoperative cycles of FEC, as given in NeoSphere
  • 3 or 4 preoperative cycles of FEC alone, followed by 3 or 4 preoperative cycles of PERJETA in combination with docetaxel and Herceptin, as given in TRYPHAENA and BERENICE, respectively 
  • 6 preoperative cycles of PERJETA in combination with docetaxel, carboplatin,§ and Herceptin (escalation of docetaxel above 75 mg/m2 is not recommended), as given in TRYPHAENA 
  • 4 preoperative cycles of ddAC alone, followed by 4 preoperative cycles of PERJETA in combination with paclitaxel and Herceptin, as given in BERENICE

Docetaxel dosing: 75 mg/m2, which could be escalated to 100 mg/m2 if initial dose was well-tolerated (escalation of docetaxel above 75 mg/m2 is not recommended when administered with carboplatin as in TRYPHAENA).
FEC dosing in NeoSphere: 5-fluorouracil (600 mg/m2), epirubicin (90 mg/m2), and cyclophosphamide (600 mg/m2); FEC dosing in TRYPHAENA and BERENICE: 5-fluorouracil (500 mg/m2), epirubicin (100 mg/m2), and cyclophosphamide (600 mg/m2).
§Carboplatin dosing: AUC 6.
ddAC dosing: doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) every 2 weeks for 4 cycles with GCSF support.
Paclitaxel dosing: 80 mg/m2.
ddAC=dose-dense doxorubicin and cyclophosphamide; FEC=5-fluorouracil, epirubicin, and cyclophosphamide.

Patient monitoring1

Left ventricular ejection fraction (LVEF)
Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits, as indicated below. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered.

Dose modifications for left ventricular dysfunction in EBC

#For patients receiving anthracycline-based chemotherapy, an LVEF ≥50% is required after completion of anthracyclines, before starting PERJETA and Herceptin.

Cardiac monitoring

Please see the full Prescribing Information for complete dosing and administration, including dose considerations, dose modifications, preparation, storage, and handling. You can also download the PERJETA Dosing & Administration Guide.

Reference