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Herceptin (Trastuzumab) - Summary

 
 



WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, AND PULMONARY TOXICITY

Cardiomyopathy

Herceptin can result in sub‑clinical and clinical cardiac failure manifesting as CHF and decreased LVEF. The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently 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 strongly consider discontinuation of Herceptin treatment in patients with metastatic breast cancer 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 infusion reactions and pulmonary toxicity. Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [ see Warnings and Precautions (5.2, 5.4) ]

 

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)

    Potential new treatment for aggressive breast cancer
    Source: Breast Cancer News From Medical News Today [2014.07.06]
    Early-stage research offers hope that a treatment could be developed against breast cancer tumors that fail to respond to the first-line drug Herceptin.

    Keeping the heart in breast cancer treatment
    Source: Breast Cancer News From Medical News Today [2014.07.18]
    Breast cancer awareness campaigns stress the importance of "saving the breasts" - but what about saving the heart?

    Detection rates of early stage breast cancer in older women unchanged despite increase in screening costs
    Source: Breast Cancer News From Medical News Today [2014.07.18]
    Medicare spending on breast cancer screening increased substantially between 2001 and 2009 but the detection rates of early stage tumors were unchanged, according to a new study published July 16 in...

    Removing Healthy Breast of Little Benefit to Breast Cancer Patients: Study
    Source: MedicineNet Ovarian Cancer Specialty [2014.07.17]
    Title: Removing Healthy Breast of Little Benefit to Breast Cancer Patients: Study
    Category: Health News
    Created: 7/16/2014 4:36:00 PM
    Last Editorial Review: 7/17/2014 12:00:00 AM

    Gene signature may predict breast cancer treatment response to tamoxifen
    Source: Breast Cancer News From Medical News Today [2014.07.15]
    A gene signature identified using a new approach has the potential to be used in the clinic to predict which patients with estrogen receptor-positive breast cancer will benefit from tamoxifen...

    more news >>

    Published Studies Related to Herceptin (Trastuzumab)

    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.

    Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101--Breast): a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI. [2011.07.27]
    BACKGROUND: MANTICORE 101 - Breast (Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research) is a randomized trial to determine if conventional heart failure pharmacotherapy (angiotensin converting enzyme inhibitor or beta-blocker) can prevent trastuzumab-mediated left ventricular remodeling, measured with cardiac MRI, among patients with HER2+ early breast cancer...

    Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)]. [2011.05]
    OBJECTIVE: This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer... CONCLUSIONS: We hereby report the study concept.

    more studies >>

    Clinical Trials Related to Herceptin (Trastuzumab)

    Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer [Active, not recruiting]
    Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel, carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical trial will also collect information (alternative therapy, response rates, overall survival) from enrolled patients with HER2 negative tumors who are ineligible to receive study treatment.

    Faslodex and Herceptin, Alone and Combined [Recruiting]
    The purpose of this study is to evaluate the the relative anti-tumor efficacy of combined Faslodex and Herceptin therapy as compared with that of Faslodex or Herceptin given alone for first-line treatment in patients with metastatic breast cancer.

    A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer [Recruiting]
    In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery patients will receive a further 10 cycles of Herceptin SC or IV as per randomization to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment for safety and efficacy. Target sample size is >500.

    Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer [Completed]
    The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.

    Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients [Completed]
    Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise metastases-free patients with early breast cancer. Several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. In almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.

    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: 2014-07-18

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