Herceptin (Trastuzumab) - Drug Info, Side Effects, Research, Clinical Trials

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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)

No Benefit Seen in Extending Herceptin for Breast Cancer
Source: MedicineNet trastuzumab Specialty [2012.12.10]
Title: No Benefit Seen in Extending Herceptin for Breast Cancer
Category: Health News
Created: 12/7/2012 12:35:00 PM
Last Editorial Review: 12/10/2012 12:00:00 AM

Herceptin May Carry Higher Heart Risks for Women Than Thought
Source: MedicineNet trastuzumab Specialty [2012.11.16]
Title: Herceptin May Carry Higher Heart Risks for Women Than Thought
Category: Health News
Created: 11/15/2012 12:35:00 PM
Last Editorial Review: 11/16/2012 12:00:00 AM

FDA Warns of Name Confusion for 2 Breast Cancer Drugs
Source: Medscape Hematology-Oncology Headlines [2013.05.06]
The use of a truncated version of the generic name for Kadcyla (ado-trastuzumab emtansine) invites a potentially harmful mix-up with Herceptin (trastuzumab), the FDA has warned.
News Alerts

Patients With Lung Cancer Who Carry Specific HER2 Mutations May Benefit From Certain Anti-HER2 Treatments
Source: Lung Cancer News From Medical News Today [2013.04.24]
New results from a retrospective study conducted in Europe suggest that anti-HER2 treatments, like the widely used breast cancer agent trastuzumab (Herceptin), have anti-cancer effects in a small subset of patients with advanced non-small cell lung cancer (NSCLC) harboring specific HER2 protein mutations...

Breast Cancer Stem Cells Express HER2, Even In 'Negative' Tumors, Study Finds
Source: Ear, Nose and Throat News From Medical News Today [2013.02.28]
New research from the University of Michigan Comprehensive Cancer Center finds that the protein HER2 plays a role even in breast cancers that would traditionally be categorized as HER2-negative - and that the drug Herceptin, which targets HER2, may have an even greater role for treating breast cancer and preventing its spread...

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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.

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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.

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