Clinical trial · Interventional
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adherence to anti-cancer therapies questionnaires | Other | — | UNRESOLVED |
| Blood samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adherence oral anticancer therapies questionnaire
- description
- Blood samples
- interventionNames
- Diagnostic Test: Blood samples
- Other: Adherence to anti-cancer therapies questionnaires
Primary outcomes (1)
- measure
- Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
- timeFrame
- one day
- description
- 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).
Secondary outcomes (15)
- measure
- Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available