EUCTR2015-003106-16-SE
Active, not recruiting
Phase 1
Immunogenicity of influenza vaccination among breast cancer patientstreated with trastuzumab in adjuvant setting
Antonis Valachis0 sitesOctober 12, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Efficacy of vaccination against influenza in patients with breast cancertreated with Trastuzumab as adjuvant therapy
- Sponsor
- Antonis Valachis
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 \< 1\.5 x 109/L
- •6\.Left ventricular ejection fraction (LVEF) less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
- •7\.Fever at time of vaccination (temperature of \= 38\.5 C).
- •8\.Known allergic reaction to any of the components of the vaccine (e.g. hypersensitivity to egg protein).
- •9\.Treatment with cortison (\> 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).
Outcomes
Primary Outcomes
Not specified
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