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Herceptin (Trastuzumab) - Summary

 
 



WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function. [see Warnings and Precautions (5.1) and Dosage and Administration (2.2)]

Infusion Reactions; Pulmonary Toxicity

Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions (5.2, 5.4) ]

Embryo Fetal Toxicity

Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)]

 

HERCEPTIN SUMMARY

Herceptin (trastuzumab) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.

Adjuvant Breast Cancer

Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies]) breast cancer

  • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • with docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline based therapy.
  • Metastatic Breast Cancer

    Herceptin is indicated:

  • In combination with paclitaxel for 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.

  • See all Herceptin indications & dosage >>

    NEWS HIGHLIGHTS

    Media Articles Related to Herceptin (Trastuzumab)

    Herceptin May Benefit Some Women With Early Breast Cancer
    Source: MedicineNet trastuzumab Specialty [2015.01.08]
    Title: Herceptin May Benefit Some Women With Early Breast Cancer
    Category: Health News
    Created: 1/7/2015 12:00:00 AM
    Last Editorial Review: 1/8/2015 12:00:00 AM

    Oncotype DX Impacts Chemotherapy Decisions in Breast Cancer
    Source: Medscape Hematology-Oncology Headlines [2015.08.28]
    A large cohort study demonstrated that Oncotype DX testing was associated with less frequent chemotherapy use in high-risk patients, but more frequent use in low-risk women.
    Medscape Medical News

    Medical News Today: Breast cancer relapse could be predicted with new blood test
    Source: Featured Health News from Medical News Today [2015.08.27]
    A new study reports that a so-called ‘mutation-tracking' blood test can pick up valuable signs of cancer’s potential return, offering hope to patients with the disease.

    Breast cancer relapse could be predicted with new blood test
    Source: Blood / Hematology News From Medical News Today [2015.08.27]
    A new study reports that a so-called ‘mutation-tracking' blood test can pick up valuable signs of cancer’s potential return, offering hope to patients with the disease.

    New 'mutation-tracking' blood test could predict breast cancer relapse months in advance
    Source: Blood / Hematology News From Medical News Today [2015.08.27]
    Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.

    more news >>

    Published Studies Related to Herceptin (Trastuzumab)

    Safety profile of Pertuzumab with Trastuzumab and Docetaxel in patients from Asia with human epidermal growth factor receptor 2-positive metastatic breast cancer: results from the phase III trial CLEOPATRA. [2014]
    metastatic breast cancer... CONCLUSION: Despite a higher proportion of docetaxel dose reductions in patients

    First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer. [2013]
    On June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease...

    Adjuvant trastuzumab in HER2-positive breast cancer. [2011.10.06]
    BACKGROUND: Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab... CONCLUSIONS: The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).

    Surgery following neoadjuvant therapy in patients with HER2-positive locally advanced or inflammatory breast cancer participating in the NeOAdjuvant Herceptin (NOAH) study. [2011.10]
    AIM: To describe surgical outcomes in patients with HER2-positive locally advanced (LABC) or inflammatory breast cancer (IBC) participating in the NeOAdjuvant Herceptin (NOAH) study (ISRCTN86043495)... CONCLUSIONS: Although this was not an aim of the trial, neoadjuvant trastuzumab given concurrently with chemotherapy enabled 23% of patients with HER2-positive LABC/IBC to avoid mastectomy (including a small number of patients with IBC). Copyright (c) 2011 Elsevier Ltd. All rights reserved.

    Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. [2011.09.01]
    PURPOSE: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited... CONCLUSION: These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.

    more studies >>

    Clinical Trials Related to Herceptin (Trastuzumab)

    A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin) and Docetaxel (Taxotere) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease [Completed]
    This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

    Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer [Completed]
    The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer. RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy. SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

    CPG 7909 Plus Herceptin� In Patients With Metastatic Breast Cancer [Completed]
    To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

    A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer [Active, not recruiting]
    The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with Herceptin in patients with advanced breast cancer.

    MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer [Completed]
    This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

    more trials >>

    Reports of Suspected Herceptin (Trastuzumab) Side Effects

    Diarrhoea (127)Death (97)Disease Progression (83)Dehydration (83)Nausea (76)Neutropenia (74)Vomiting (71)Febrile Neutropenia (63)Fatigue (60)Dyspnoea (57)more >>


    Page last updated: 2015-08-28

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