7 Phase II or III clinical trials evaluated the efficacy, safety, and tolerability of Herceptin1,6-15

20+ years on the market since approval of first indication in 19984

Based on a report, 2.3 million patients worldwide were treated with Herceptin to date16

Adjuvant Breast Cancer 1

Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel

  • With docetaxel and carboplatin

  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.

*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Herceptin was studied as adjuvant treatment in 4 pivotal trials involving more than 10,000 people with HER2+ breast cancer. 1

The primary endpoint was DFS, defined as the time from randomization to recurrence, occurrence of contralateral breast cancer, other second primary cancer, or death.

Studies in adjuvant breast cancer

Studies 1 and 2

Study 3

Study 4

Metastatic Breast Cancer 1

Herceptin is indicated:

  • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer

  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.

Herceptin was studied in 2 pivotal trials involving more than 600 people with HER2+ metastatic breast cancer. 1

The primary endpoint was median TTP in one trial and ORR in the other trial.

Studies in metastatic breast cancer

Study 5

Study 6

Metastatic Gastric/GEJ Cancer 1

Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.

Herceptin was studied in 1 pivotal trial involving 594 people with HER2+ metastatic gastric cancer. 1

The primary endpoint was OS.

Studies in metastatic gastric cancer

Study 7

Across approved indications, Herceptin has been used to treat more than 2.3 million patients to date 16

Drug utilization assumptions were considered in order to calculate the number of patients exposed to Herceptin by indication worldwide, including US and Japan. 

Patients treated is based on the PBRER report of patient exposure, which was calculated based on the global total milligram volume sales divided by the average dose per patient per year, based on US approved indications.

Average dose per patient was based on an average patient weight multiplied by mean dose divided by average treatment duration. Assumption of patient exposures from PBRER report may not necessarily correspond to a unique patient.

Excluding Japan, the average body weight was sourced from internal data sources ex-US and ranged between 65-75 kg in the US. Average dose was based on the approved dose of each indication. Note: Some dose interruptions may have been accounted for per clinician discretion. In Japan, total dose for each given indication was sourced from sales assumption data during that year and dose per patient per indication was sourced from 2014 sales assumption data.

PBRER=Periodic Benefit-Risk Evaluation Report.


Learn more about Herceptin dosing and administration.

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