Clinical trial · Interventional
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant. The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | — | UNRESOLVED | — |
| Estrogen Receptor-Positive Breast Cancer | — | UNRESOLVED | — |
| HER2-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Giredestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A: Upfront Adjuvant Endocrine Therapy Population
- description
- Participants will receive giredestrant.
- interventionNames
- Drug: Giredestrant
- type
- EXPERIMENTAL
- label
- Cohort B: Switch Adjuvant Endocrine Therapy Population
- description
- Participants will receive giredestrant.
- interventionNames
- Drug: Giredestrant
Primary outcomes (1)
- measure
- Incidence of Participants who Have Discontinued Giredestrant for any Reason
- timeFrame
- Month 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer * Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy) * Participants must have completed any prior adjuvant chemotherapy before enrollment, if given * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 * Adequate organ function * Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required * Diagnosis of inoperable locally advanced or Stage IV breast cancer * History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS) * Planned surgery during the study * Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents * Active cardiac disease or history of cardiac dysfunction
References
Publications (0)
Data not yet available