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Tests treatment safety and results for Breast Cancer
Official title A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer
ClinicalTrials.gov ID: NCT06781996
What this study is testing
- What it's testing
- Randomized trial that compares a personalized digitally-enabled pathway delivered by a mobile application in addition to standard of care vs. standard of care alone in patients with HR+ early breast cancer reporting endocrine therapy related adverse events.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documentation of Disease:
- people must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
- people must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease; NB: Bilateral breast carcinoma is...
- Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP...
- Prior treatment: Patients must be actively on ET for their breast cancer diagnosis (any type, including either tamoxifen or an aromatase-inhibitor...
You likely can't join if
- Severe cognitive impairments or severe psychiatric disorders (assessed by the investigator or mentioned in the medical file of the patient) which in...
- Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent;
- Patients participating at enrollment in a behavioral treatment trial;
- Patients suffering from physical related reversible and treatable causes of the entry endocrine therapy-related adverse events (e.g. but not limited...
See the full eligibility criteria
- Documentation of Disease:
- people must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
- people must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease; NB: Bilateral breast carcinoma is allowed; NB: Patients with personal history of previous breast cancer...
- Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP inhibitors, bisphosphonates);
- Prior treatment: Patients must be actively on ET for their breast cancer diagnosis (any type, including either tamoxifen or an aromatase-inhibitor with or without targeted agents) at the time of study enrollment;
- Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy;
- Others:
- Age ≥ 18 years;
- ECOG Performance Status 0,1 or 2;
- Patients should possess a smartphone;
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed;
- Patient should be able and willing to comply with study visits and procedures as per protocol;
- Patients must be affiliated to a social security system or beneficiary of the same;
- Able to readily read and understand French; NB: Patients may have breast reconstruction during protocol participation; NB: Biologic therapy, targeted therapy and bisphosphonates are acceptable during protocol...
- Severe cognitive impairments or severe psychiatric disorders (assessed by the investigator or mentioned in the medical file of the patient) which in the investigator's opinion would jeopardize compliance with the...
- Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent;
- Patients participating at enrollment in a behavioral treatment trial;
- Patients suffering from physical related reversible and treatable causes of the entry endocrine therapy-related adverse events (e.g. but not limited to anemia, electrolytes unbalance, infections, renal dysfunction...
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.