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Giredestrant / Early Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration evaluating giredestrant as adjuvant endocrine therapy in patients with ER+/HER2− early breast cancer who are intolerant to aromatase inhibitors. No results are available in this registry record; the study is actively recruiting and outcomes will be assessed at 12 months (discontinuation) and through safety follow-up up to 4 years 7 months.
Phase 3, Interventional, Single Group, Open label, Treatment purpose. Early Breast Cancer; Female; age from 18 Years. Intervention: Giredestrant. n = 300. 2 sites: United States.
This is a Phase 3 trial registration evaluating giredestrant as adjuvant endocrine therapy in patients with ER+/HER2− early breast cancer who are intolerant to aromatase inhibitors. No results are available in this registry record; the study is actively recruiting and outcomes will be assessed at 12 months (discontinuation) and through safety follow-up up to 4 years 7 months.
This is a registry record only; no efficacy, safety, or outcome data are reported.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and primary outcomes have not yet been assessed.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07541079). This is a study registration, not published results. Lead sponsor: Genentech, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Early Breast Cancer. Interventions: DRUG: Giredestrant. Primary outcome measures: Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months , At 12 months; Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0) , From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.