Breast CancerAdOTACNCT06435546
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers
A study testing Blood samples and Adherence to anti-cancer therapies questionnaires in people with Breast Cancer and Prostate Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Blood samples and Adherence to anti-cancer therapies questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2024to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 18 years old.
- Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
- Oral anticancer medications started for at least 3 months.
- With a performance status ≤ 3.
- Patient has understood, signed and dated the consent form.
- Patient covered by the social security system.
Who cannot join
- Patient with early breast cancer or localized prostate cancer.
- Patient with life expectancy < 3 months.
- Patient in progression
- Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
- Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
- Patient unable to read or speak French.
- Patient already included in another therapeutic trial with an experimental molecule.
- Persons deprived of their liberty or under guardianship (including curatorship).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Blood samples, Adherence to anti-cancer therapies questionnaires
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin
Adherence to anti-cancer therapies questionnairesOther
GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS
| Study group | Role | What they receive |
|---|---|---|
| Adherence oral anticancer therapies questionnaire | Experimental | Blood samples Receives: Diagnostic Test: Blood samples; Other: Adherence to anti-cancer therapies questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Medication adherence to oral anticancer treatments will be assessed using a score based on the GIRERD adherence assessment (targeting oral anticancer treatments).
The score is a scale ranging from 0 to 6 (good compliance = 6; poor compliance = 4 to 5; non-adherence ≤ 3).
Measured: one day
Secondary outcomes (15)
Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
The performance status by the ECOG-PS score (0 to 4).
Measured: one day
Identify if comorbitities is associated with reduced adherence to oral anticancer treatments
Comorbidities using the Charlson score (0 to 37).
Measured: one day
Identify if polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications is associated with reduced adherence to oral anticancer treatments
Polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications (0 to >5).
Measured: one day
Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments
The treatment regimen by a level of complexity (4 levels) given by an oncologist.
Measured: one day
Identify if biological markers are associated with reduced adherence to oral anticancer treatments
Biological markers (ferritin, TSAT, serum iron, haemoglobin, albumin) by a blood test.
Measured: one day
Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments
Sarcopenia by the body mass/fat mass ratio using imaging (SMI: skeletal muscle mass index).
Measured: one day
Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments
Quality of life using the EORTC-QLQ-C30 questionnaire score.
Measured: one day
Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments
Social and emotional support by the MSPSS questionnaire (Multidimensional Scale of Perceived Social Support) (12-35: low perceived support; 36-60: medium perceived support; 61-84: hugh perceived support)
Measured: one day
Identify if HADS scale is associated with reduced adherence to oral anticancer treatments
Anxiety and/or depression using the Hospital Anxiety and Depression Scale (HADS).
(If the score in a column is greater than or equal to 11, it means person suffer from anxiety or depression)
Measured: one day
Identify if MNA is associated with reduced adherence to oral anticancer treatments
Malnutrition using the MNA (Mini-Nutritional Assessment) questionnaire (24-30 points: normal nutritional status; 17-23.5 points: at risk of malnutrition; less than 17 points: malnourished)
Measured: one day
Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments
Use of social networks and alternatives and complementary medicines using patient questionnaire developed specifically for the study population.
Measured: one day
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Medication adherence to oral anticancer treatments will also be assessed using the score from the new AdOT questionnaire. The score is a scale ranging from 0 (no adherence) to 100 (perfect adherence).
Measured: one day
Study the relationship between the two adherence questionnaires.
Subgroup analysis by cancer type (breast; prostate), use of alternatives and complementary medicines (yes; no) and use of social media and networks (yes; no).
Measured: one day
Describe and compare medication adherence to oral treatments
The correlation between the scores on the GIRERD and AdOT will be analysed.
Measured: one day
Describe and compare patient characteristics (socio-demographic, clinical and contextual), medication adherence to oral anticancer treatments according to cancer type, use of alternative and complementary medicines and use of social media and networks.
Subgroup analysis by cancer type (breast; prostate), use of alternative and complementary medicines (yes; no) and use of social media and networks (yes; no).
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start4 Jun 2024
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Massard, MD, Principal investigator, Institut de Cancérologie de LorraineNaoual Boujedaini, PhD, Study chair, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435546
- Sponsor's protocol ID
- 2024-A00396-41
- Acronym
- AdOTAC
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
- ClinicalTrials.gov ID
- NCT06435546
- Acronym / sponsor ID
- AdOTAC / 2024-A00396-41
- Conditions
- Breast Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 30 May 2024 (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.
AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adherence oral anticancer therapies questionnaire | Experimental | Diagnostic Test: Blood samples, Other: Adherence to anti-cancer therapies questionnairesBlood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult over 18 years old.
- Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
- Oral anticancer medications started for at least 3 months.
- With a performance status ≤ 3.
- Patient has understood, signed and dated the consent form.
Key exclusion criteria (8 listed)
- Patient with early breast cancer or localized prostate cancer.
- Patient with life expectancy < 3 months.
- Patient in progression
- Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
- Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
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 |
|---|---|---|
| Blood samplesFerritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin | Diagnostic test | Adherence oral anticancer therapies questionnaire |
| Adherence to anti-cancer therapies questionnairesGIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS | Other | Adherence oral anticancer therapies questionnaire |
Primary outcome
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Time frame: one day
Medication adherence to oral anticancer treatments will be assessed using a score based on the GIRERD adherence assessment (targeting oral anticancer treatments). The score is a scale ranging from 0 to 6 (good compliance = 6; poor compliance = 4 to 5; non-adherence ≤ 3).
15 secondary outcomes
Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if comorbitities is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if biological markers are associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if HADS scale is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if MNA is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments
Time frame: one day
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Time frame: one day
Study the relationship between the two adherence questionnaires.
Time frame: one day
Describe and compare medication adherence to oral treatments
Time frame: one day
Describe and compare patient characteristics (socio-demographic, clinical and contextual), medication adherence to oral anticancer treatments according to cancer type, use of alternative and complementary medicines and use of social media and networks.
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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. This study is not recruiting at the moment.
Vincent Massard, MD principal investigator
Institut de Cancérologie de Lorraine
Naoual Boujedaini, PhD study chair
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and Adherence to anti-cancer therapies questionnaires in people with Breast Cancer and Prostate Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer. (time frame: one day). 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 27 Mar 2026.