Effectiveness of infuenza vaccination in patients with breast cancer treatedwith trastuzumab postoperatively

Phase 1

• Conditions: Efficacy of vaccination against influenza in patients with breast cancertreated with Trastuzumab as adjuvant therapy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003106-16-SE
• Lead Sponsor: Antonis Valachis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

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).
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 < 55, must have a negative pregnancy test at baseline.
15.Unwilling or unable to comply with the protocol for the duration of the study.

For the healthy control group, we will include women > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified