Breast CancerVAC-SEINNCT07888881
An Overview of Vaccination Coverage Among Patients Receiving Treatment for Breast Cancer at the ICO: Identifying Factors Associated With Vaccination Uptake and Improved Prevention
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest.
Trial summary
Primary prevention, vaccination, ,state of vaccination coverage in oncology, , breast cancer patients, factors influencing adherence in order to improve prevention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaire on vaccination status
- Type of treatment
- Vaccines
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women currently undergoing intravenous chemotherapy for non-metastatic breast cancer, as part of adjuvant or neo-adjuvant treatment
Who may be able to join
- Non-metastatic breast cancer,
- Currently undergoing adjuvant or neoadjuvant intravenous chemotherapy,
Who cannot join
- Performance Status (PS) > 2,
- Multiple 'active cancers',
- Pregnant women,
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary prevention, vaccination, ,state of vaccination coverage in oncology, , breast cancer patients, factors influencing adherence in order to improve prevention.
Read the detailed description
Primary prevention, defined by the WHO as a key strategy for reducing the incidence of disease, relies in part on vaccination, the individual and collective effectiveness of which is recognised. In France, despite vaccination coverage targets of 95 per cent for most vaccines, current studies highlight persistent gaps, particularly among at-risk populations, such as people aged over 65, those with compromised immune systems and cancer patients. Despite a high theoretical uptake rate (83.7 per cent), studies (COVARISQ, 2020 and Granger, 2022) have shown insufficient vaccination coverage (e.g. 9.5 per cent for pneumococcal vaccine, 40.2 per cent for influenza). The aim of this protocol is to assess the current state of vaccination coverage in oncology, particularly amongst breast cancer patients, and to identify factors influencing adherence in order to improve prevention.
- Conditions
- Breast Cancer
- Being tested
- questionnaire on vaccination status
- Keywords
- breast cancer, vaccination, prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire on vaccination statusOther
questionnaire on vaccination status
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer starting chemotherapy | Breast cancer starting chemotherapy Receives: Other: questionnaire on vaccination status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination coverage
To estimate the proportion of female breast cancer patients, at the time of their initial assessment at an oncology day hospital (HDJ) as part of adjuvant or neoadjuvant systemic treatment, who are fully up to date with the recommended vaccinations against the following pathogens: pneumococcus, VZV (shingles), dTcaP and hepatitis B.
Measured: 9 weeks
Secondary outcomes (2)
Vaccination uptake
To identify the factors that promote vaccination uptake among women being treated for breast cancer in an oncology day centre whilst undergoing adjuvant or neoadjuvant systemic therapy
Measured: 9 weeks
Compare vaccination coverage among patients aged 70 and over with that of other patients
Compare vaccination coverage among patients aged 70 and over with that of other patients
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra BAFOURD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888881
- Sponsor's protocol ID
- ICO-2025-25
- Other IDs
- 2026-A00640-51
- Acronym
- VAC-SEIN
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided