A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 2 → 8 locations
  2. Study sites: 2 to 4
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 7 entries
  3. Re-verified, no change to tracked fieldsv8
  4. Start date changed from estimate of Aug 15, 2026 to Aug 25, 2026v7
  5. Study sites: 1 to 2v6
  6. Recruitment opened
    • Start date: Jun 30, 2026 to Aug 15, 2026
    • Study sites: 0 to 1
    v5
  7. Study Status, Contacts/Locations, Referencesv4
  8. Re-verified, no change to tracked fieldsv3
  9. Secondary endpoints: details revised at 3 of 7 entriesv2
  10. Study First Submitted
  • 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.
Roche/Genentech
368 trials monitored
See 30 trials at risk
Breast Cancer
5,466 trials monitored
See 312 trials at risk
The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.
Trial Details
NCT Number NCT07541079
Lead Sponsor Genentech, Inc.
Conditions
(from sponsor)		 Early Breast Cancer
Related terms Breast Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov