TRASTUZUMAB Sample Clauses

TRASTUZUMAB. Trastuzumab is a monoclonal antibody directed against the HER2 receptor protein on breast cancer cells and it has been used alone or in combination with other chemotherapeutic agents. Cardiac toxicity associated with trastuzumab seems to be similar with the congestive heart failure observed with anthracycline therapy. Evaluation of data of 1024 patients who received trastuzumab revealed that combination therapy of trastuzumab with an anthracycline and cyclophosphamide showed 28% of reported cardiac dysfunction against 3–5% with doxorubicin monotherapy (cumulative dosage 400 mg/m2 ). Concomitant anthracycline therapy and age appeared to be independent risk factors [90]. When receiving trastuzumab as single therapy in an open label study, 7% of the women developed heart failure [91].
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TRASTUZUMAB. Trastuzumab (Herceptin) is a recombinant humanized monoclonal anti-HER2 antibody developed by Genentech. It is approved by the US Food and Drug Administration for treatment in patients with metastatic HER2-overexpressing breast cancer (Xxxxxxxxxx et al, 1999). Trastuzumab is a purified recombinant DNA-derived humanized monoclonal antibody produced using hamster ovaries in medium containing the antibiotic gentamicin. The antibody contains human regions with complementary regions of murine 4D5 antibody (Stancovski et al, 1991). Trastuzumab selectively binds to domain IV of the extracellular region of HER2, and has been administered either as a single agent or in combination with paclitaxel or carboplatin, resulting in a significant inhibition of tumors that overexpress HER2. The mean half-life of trastuzumab is 5.8 days, with steady state of serum achieved when there is a mean trough of 79pg/mL and peak concentration of 123pg/mL (Baselga et al, 1996). Early preclinical and clinical studies investigating the effectiveness of trastuzumab provide evidence it is clinically beneficial. In a single arm clinical study consisting of 222 patients with HER2-overexpressing breast cancer, single agent trastuzumab treatment administered intravenously with a loading dose of 4mg/kg followed by weekly 2mg/kg doses resulted in a response rate of 14% (Xxxxxxxx et al, 1998). In another study, 469 metastatic HER2-overexpressing breast cancer patients were treated with either paclitaxel and cyclophosphamide, or anthracycline and cyclophosphamide, both in the absence or presence of trastuzumab (Xxxxxx et al, 1998). Study results showed patients with trastuzumab as a part of their treatment regimen had a significantly better overall response when compared to patients treated with chemotherapy alone, with the greatest benefit observed in the paclitaxel plus trastuzumab group. Common adverse effects observed with trastuzumab treatment include fever, chills, pain, asthenia, vomiting, diarrhea, headache, dyspnea, rhinitis, and insomnia. Ten years later, trastuzumab is still the first line treatment for HER2 positive breast cancer (Xxxx et al, 2010, Xxxxxxx et al, 2010). Recent studies show trastuzumab treatment provides a significant benefit for patients with various stages of breast cancer, with the addition of trastuzumab to neoadjuvant chemotherapy resulting in a 33% increase in overall survival and reduced recurrence rate when administered in early stage breast cancer (Xxxxxxxx et...

Related to TRASTUZUMAB

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  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.

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