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A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization

Study acronym: Close2HER
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later May 31, 2028 → Oct 31, 2028
See other at-risk trials from Roche/Genentech

Record History

  1. Minor Primary and study completion pushed from May 31, 2028 to Oct 31, 2028
  2. Minor Eligibility criteria expanded, about 6 words Secondary endpoints: details revised at 9 of 12 entries · Site details revised at 3 of 10 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 9 of 12 entries
    • Site details revised at 3 of 10 sites
  3. Minor 3 versions Re-verified since Jul 4, 2026, no change to tracked fieldsv4-v6
  4. Minor Study Status, Contacts/Locations, Referencesv3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC). This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy.
Trial Details
NCT Number NCT07527741
Lead Sponsor Hoffmann-La Roche
Conditions Early-stage HER2+ Breast Cancer
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov