Select patients based on HER2 protein overexpression or HER2 gene amplification1

Assessment of HER2 protein overexpression and HER2 gene amplification in tumor specimens should be performed using FDA-approved tests specific for breast or gastric cancers by laboratories with demonstrated proficiency.

Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available here.

Do not:

  • administer as an intravenous push or bolus
  • mix Herceptin with other drugs
  • substitute Herceptin (trastuzumab) for or with ado-trastuzumab emtansine

Adjuvant Breast Cancer1

Patient Selection

Appropriate patients for adjuvant Herceptin therapy have HER2+ breast cancer that is node-positive—OR node-negative and the cancer is also hormone-negative (HR–)—OR node-negative and the patient has one of these high-risk factors: tumor grade 2 or 3, tumor size >2 cm, or patient age <35 years.

Adjuvant Breast Cancer Dosing Schedule

Regimen Loading dose Subsequent doses during
weekly administration
Subsequent doses during
every 3 weeks administration to complete 52 weeks of Herceptin therapy
TCH 4 mg/kg
(week 1)
2 mg/kg
(weeks 2-18)
6 mg/kg
(week 19 through end of Herceptin therapy)
AC TH 4 mg/kg
(week 1 of Herceptin-containing regimen)
2 mg/kg
(weeks 2-12 of Herceptin-containing regimen)
6 mg/kg
(week 13 through end of Herceptin therapy)
Monotherapy* 8 mg/kg
(week 1)
N/A 6 mg/kg
(week 4 through end of Herceptin therapy)
Infusion time 90 minutes 30 minutes 30–90 minutes

Extending adjuvant treatment beyond 1 year is not recommended.1

*Within 3 weeks after completing all chemotherapy.
TCH=docetaxel and carboplatin plus Herceptin.
AC➝TH=doxorubicin and cyclophosphamide followed by paclitaxel or docetaxel plus Herceptin.

Metastatic Breast Cancer1

Patient Selection

In the metastatic breast cancer clinical trials, patients were eligible if they had 2 or 3 levels of overexpression (based on a 0 to 3 scale) by immunohistochemical assessment of tumor tissue performed by a central testing lab.

Metastatic Breast Cancer Dosing Schedule

Regimen Loading dose Subsequent doses during weekly administration
Combination with paclitaxel 4 mg/kg
(week 1)
2 mg/kg
(until disease progression)
Monotherapy 4 mg/kg
(week 1)
2 mg/kg
(until disease progression)
Infusion time 90 minutes 30 minutes

Metastatic Gastric/GEJ Cancer1

Patient Selection

Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.

Metastatic Gastric Cancer Dosing Schedule

Regimen Loading dose Subsequent doses administered every 3 weeks
Monotherapy 8 mg/kg
(week 1)
6 mg/kg
(until disease progression)
Infusion time 90 minutes 30–90 minutes

Additional dosing considerations1

When to discontinue Herceptin due to Infusion reactions

Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Discontinue in all patients with severe infusion reactions.

  • Decrease the rate of infusion for mild or moderate infusion reactions
  • Interrupt the infusion in patients with dyspnea or clinically significant hypotension
  • Discontinue Herceptin for severe or life-threatening infusion reactions

If a dose of Herceptin therapy is missed

If a dose is missed by ≤1 week:

  • The usual maintenance dose (based on the patient's schedule) should be administered as soon as possible
  • Do not wait until the next planned cycle
  • Subsequent Herceptin maintenance doses should be administered 7 days or 21 days later according to the patient's schedule

If a dose is missed by >1 week:

  • Herceptin should be reloaded using the appropriate loading dose administered over approximately 90 minutes

Frequent cardiac monitoring is recommended for patients receiving Herceptin1

  • Conduct a thorough cardiac assessment prior to Herceptin treatment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Monitor LVEF frequently during and after Herceptin treatment

LVEF=left ventricular ejection fraction; MUGA=multigated acquisition scan.

In the Joint Analysis, baseline measurement was conducted prior to initiation of AC therapy.
Repeat LVEF measurements at 4-week intervals if Herceptin is withheld for significant left ventricular cardiac dysfunction.

Hold and reinitiation criteria for patients receiving Herceptin

ECHO=echocardiogram; LLN=lower limit of normal; LVEF=left ventricular ejection fraction; MUGA=multigated acquisition scan.

Hold and reinitiate up to 3 times in patients with asymptomatic declines in LVEF.

The safety of continuation or resumption in patients with Herceptin-induced left ventricular dysfunction has not been studied.

Discontinue Herceptin permanently if any of the following occurs:

  • Patient presents with congestive heart failure
  • Clinically significant asymptomatic decreases in left ventricular function
  • Persistent (>8 weeks) LVEF decline is observed
  • Herceptin dosing is held on more than 3 occasions for cardiomyopathy

Learn more about how Herceptin is thought to work.

See details about Genentech’s commitment to supporting patient access and physician choice.

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HER2-Targeted Therapy

See information about Herceptin in combination with another HER2-targeted agent + chemotherapy for early breast cancer treatment.

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A Subcutaneous Option

Looking for dosing information for Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk)?

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Financial Assistance for Your Patients

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