Digital Self-management for Early Breast Cancer Treatment
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
Recruiting
Phase 3Interventional Study
Breast CancerBreast Cancer Early Stage Breast Cancer (Stage 1-3)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
180 (estimated)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Other
Who this trial is looking for
This trial is looking for women and men with early-stage breast cancer who are experiencing side effects from their hormone therapy. Participants will use a mobile app designed to help manage their treatment alongside their usual care.
Are You a Good Fit for This Trial?
Must be takingTamoxifenAromatase inhibitors
You may be able to join if
I have been diagnosed with early-stage breast cancer.
I am currently receiving hormone therapy for my breast cancer.
I am at least 18 years old.
I have a smartphone.
I can read and understand French.
I have reported side effects from my hormone therapy.
I have a performance status of 0, 1, or 2.
You may not be able to join if
I have severe cognitive impairments or psychiatric disorders.
I am currently participating in another clinical trial.
I am unable to consent to participate in the study.
My side effects are due to treatable physical conditions.
I am under guardianship or liberty deprivation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
The HOPE study is a national, prospective, randomized, open-label trial conducted in France. 180 patients will be randomly assigned 1:1 to re…
Inclusion Criteria:
1. Documentation of Disease:
1. Subjects must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
2. Subjects must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease;
NB: Bilateral breast carcinoma is…
Inclusion Criteria:
1. Documentation of Disease:
1. Subjects must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
2. Subjects 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 or Ductal Carcinoma in situ (DCIS) are eligible for the protocol;
2. Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP inhibitors, bisphosphonates);
3. 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;
4. Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy;
5. Others:
1. Age ≥ 18 years;
2. ECOG Performance Status 0,1 or 2;
3. Patients should possess a smartphone;
4. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed;
5. Patient should be able and willing to comply with study visits and procedures as per protocol;
6. Patients must be affiliated to a social security system or beneficiary of the same;
7. 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 participation;
NB: Male patients can be included in the trial;
NB: Pharmacological or other non-pharmacological interventions for endocrine treatment for adverse effects are accepted at physician discretion.
Exclusion Criteria:
1. 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 protocol;
2. Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent;
3. Patients participating at enrollment in a behavioral interventional trial;
4. 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, active metastases hormonal unbalances \[hypothyroidism, adrenal insufficiency, etc.\] - according to physician's judgement.
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