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 3 Interventional Study
Breast Cancer Breast 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 taking TamoxifenAromatase 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.

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Check Your Eligibility
About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Maria Alice FRANZOI, MD

+33142114211

Mariaalice.BORINELLI-FRANZOI@gustaveroussy.fr

CONTACT

Chloé Serhal, PhD

+33142114211

Chloé.serhal@gustaveroussy.fr

CONTACT