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
- Are there results?
- Not yet: the study is under way
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
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-2025-24
- Other IDs
- 2026-A00640-51
- Acronym
- VAC-SEIN
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Overview of Vaccination Coverage Among Patients Receiving Treatment for Breast Cancer at the ICO: Identifying Factors Associated With Vaccination Uptake and Improved Prevention
- ClinicalTrials.gov ID
- NCT07888881
- Acronym / sponsor ID
- VAC-SEIN / ICO-2025-24
- Conditions
- Breast Cancer
- Keywords
- breast cancer, vaccination, prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary prevention, vaccination, ,state of vaccination coverage in oncology, , breast cancer patients, factors influencing adherence in order to improve prevention.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer starting chemotherapy | – | Other: questionnaire on vaccination statusBreast cancer starting chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women currently undergoing intravenous chemotherapy for non-metastatic breast cancer, as part of adjuvant or neo-adjuvant treatment
Key inclusion criteria (2 listed)
- Non-metastatic breast cancer,
- Currently undergoing adjuvant or neoadjuvant intravenous chemotherapy,
Key exclusion criteria (3 listed)
- Performance Status (PS) > 2,
- Multiple 'active cancers',
- Pregnant women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire on vaccination statusquestionnaire on vaccination status | Other | Breast cancer starting chemotherapy |
Primary outcome
Vaccination coverage
Time frame: 9 weeks
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.
2 secondary outcomes
Vaccination uptake
Time frame: 9 weeks
Vaccination coverage among patients aged 70 and over with that of other patients
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra BAFOURD principal investigator
Institut de Cancérologie de l'Ouest
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia HIMPE (+33 2 40 67 97 47, laetitia.himpe@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination coverage (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.