Understanding how well patients with advanced breast and prostate cancers follow their oral therapies
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
This study is trying to see how well people with advanced breast and prostate cancers stick to their oral medications by having them fill out questionnaires and provide blood samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT06435546 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess adherence to oral therapies in patients with inoperable advanced breast and prostate cancers. It will involve 200 participants who will complete self-questionnaires regarding their adherence to treatment, either at the clinic or at home within 10 days of enrollment. Blood samples will be collected on Day 0 to measure various biological markers related to their condition. The study focuses on patients who have been on oral anticancer medications for at least three months and have a performance status of 3 or less.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with inoperable advanced breast or prostate cancer who have been on oral therapies for at least three months.
Not a fit: Patients with early-stage cancers or those undergoing intravenous chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of treatment adherence, potentially leading to better management strategies for patients with advanced cancers.
How similar studies have performed: While there have been studies on treatment adherence in cancer patients, this specific approach focusing on advanced breast and prostate cancers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Vandœuvre-lès-Nancy
- Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Vincent Massard, MD — Institut de Cancérologie de Lorraine
- Study coordinator: Vincent Massard, MD
- Email: v.massard@nancy.unicancer.fr
- Phone: +33383598461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.