> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-how-well-participants-with-a-specific-type-18917ff1-7f98-4d8d-84c5-daf2d96c22ed > Record changed: 2026-11-04 # 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 NCT07827573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) Participants 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) Start date 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Acronym** kalitERA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Official title** 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](https://clinicaltrials.gov/study/NCT07827573) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Dates **Completion date** 2032-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **First posted** 2026-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Registry last updated** 2026-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Primary completion date** 2028-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Start date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Size and sites **Participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Planned participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Identifiers **Registry ID** NCT07827573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **ClinicalTrials.gov ID** NCT07827573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Outcomes ### Primary outcomes 1. Incidence of Participants who Have Discontinued Giredestrant for any Reason Timeframe: Month 12 ### Secondary outcomes 1. Incidence and Severity of Adverse Events (AEs) Timeframe: Up to approximately 5 years 2. Treatment Adherence, as Measured by Dose Intensity Timeframe: Up to approximately 5 years 3. Treatment Adherence, as Measured by Treatment Duration Timeframe: Up to approximately 5 years 4. Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Timeframe: At prespecified timepoints from Baseline until approximately 5 years 5. Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 6. Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 7. Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 8. Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 9. Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 10. Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 11. Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES Timeframe: At prespecified timepoints from Baseline until approximately 5 years 12. Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 13. Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 14. Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 15. Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 16. Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 17. Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score Timeframe: At prespecified timepoints from Baseline until approximately 5 years 18. Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) Timeframe: At prespecified timepoints from Baseline until approximately 5 years 19. Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G Timeframe: At prespecified timepoints from Baseline until approximately 5 years 20. Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES Timeframe: Month 6 and Month 12 21. Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES Timeframe: Month 6 and Month 12 22. Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES Timeframe: Month 6 and Month 12 23. Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES Timeframe: Month 6 and Month 12 24. Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score Timeframe: Month 6 and Month 12 25. Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score Timeframe: Month 6 and Month 12 And 14 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2026-526742-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07827573) ## Related records ### Drugs (1) - [Giredestrant](https://trialight.com/data/asset/giredestrant-c67ceef7-88fc-49f5-b635-5568fc80cd3c.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (2) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition - [Estrogen-receptor positive breast cancer](https://trialight.com/data/condition/estrogen-receptor-positive-breast-cancer-3bdba21b-1ba5-534a-9e7a-1d3f4d76885f.md) ### Targets (1) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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