Efficacy of vaccination against influenza in patients with breast cancer treated with Trastuzumab as adjuvant therapy
Conditions
Interventions
Trade Name: Trastuzumab
Product Name: Herceptin
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
Trade Name: Fluarix
Product Name: Fluarix
Pharmaceutical Form: Suspen
Sponsors
Antonis Valachis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with stage I-II or operable stage III HER2 – positive (FISH or CISH with amplification and / or +++ in immunohistochemistry) breast cancer, after breast cancer surgery (breast-conserving surgery or mastectomy), without any clinical or radiological signs of distant metastasis (radiologic work-up is not necessary; according to local guidelines). 2. Woman > 18 years of age. 3. Radiotherapy (local or locoregional) prior or during the study inclusion period is allowed. 4. Endocrine therapy (tamoxifen or aromatase inhibitors) is allowed. 5. Prior neoadjuvant or adjuvant chemotherapy is allowed only if the time period between the last cycle of chemotherapy and inclusion to the study is at least 1 month. 6. Both intravenous and subcutaneous formulations of trastuzumab are allowed. 7. Able to read, understand, and sign informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Inflammatory breast cancer or inoperable stage III breast cancer. 2. Presence of distant metastases. 3. Possible change of anti-cancer treatment before the first evaluation of immunogenicity following the first injection (to avoid bias related to any therapy changes). 4. History of another malignancy within the last 5 years except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix. 5. Neutrophils 15 mg prednisolone or equivalent daily) or any other immunosuppressive agent at the moment of vaccination. 10. Any other immunosuppressive disease (such as HIV infection, renal insufficiency, cirrhosis). 11. History of clinically or virologically confirmed influenza infection in the previous 6 months. 12. Any other immunization carried out in the 3 weeks before the first injection or planned in the following month. 13. Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential within seven days prior to the first dose of study drug. 14. Women of childbearing potential unless using a reliable and appropriate contraceptive method (hormonal methods: combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices; non-hormonal methods: intrauterine device, tubal ligation, complete abstinence, barrier method (condoms, diaphragm) also in conjuction with spermicidal jelly; total abstinence). Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age 18 years old (employees of participating hospitals that voluntarily participate in the yearly influenza vaccination campaign for health care personnel) that have not been diagnosed with breast cancer, they fulfill inclusion criterion 7, and do not fulfill any of the exclusion criteria 7-15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the immunogenicity of influenza vaccination in breast cancer patients treated with trastuzumab in adjuvant setting;Secondary Objective: Secondary aim is to investigate the tolerability of influenza vaccination to this group of breast cancer patients;Primary end point(s): The primary outcome of the study is the immunogenicity to influenza vaccination in breast cancer patients treated with adjuvant trastuzumab. The immunogenicity will be tested by using the following endpoints: 1. Geometric mean titers of HI after vaccination, with a response defined as greater than or equal to a 4-fold (a sensitivity analysis will be performed with a threshold of 2.5) increase in a population. 2. Postvaccination seroconversion rate (SCR) which is defined as the proportion of patients with a fourfold or greater increase in HI antibodies between baseline and day 28 ± 3 and 90 ± 7. 3. Seroprotection rate (SPR), defined as the percentage of patients with a titer of least 1:40.;Timepoint(s) of evaluation of this end point: Blood samples will be drawn at three time periods in all three study groups: at baseline (before influenza vaccination), on day 28 ± 3 (one month after vaccination) and on day 90 ± 7 (3 months after vaccination). The measures for the primary endpoint will be evaluated at the above 3 timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The tolerability (local and systemic adverse events) of the influenza vaccination in both patients and controls will be evaluated.;Timepoint(s) of evaluation of this end point: The occurrence of adverse events (AE) will be sought by non-directive questioning of the patient during visit 1 after signing informed consent and at each visit during the study. AEs of the influenza vaccination in both patients and controls will also be evaluated by using a questionnaire every week until 21 days after vaccination (day 7, 14, 21). The questionnaire will be sent by post to the participants. | — |
Countries
Sweden
Contacts
Public ContactAntonis Valachis
Antonis Valachis
Outcome results
None listed