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
- 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.
- Acronym
- kalitERA
- 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
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2032-11-30
- First posted
- 2026-09-18
- Registry last updated
- 2026-10-15
- Primary completion date
- 2028-11-30
- Start date
- 2026-10-30
- Participants
- 1,500
- Participant count basis
- Estimated
- Planned participants
- 1,500
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hoffmann-La Roche
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07827573
- ClinicalTrials.gov ID
- NCT07827573
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Timeframe: Month 12
Incidence and Severity of Adverse Events (AEs)
Timeframe: Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Timeframe: Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Timeframe: Up to approximately 5 years
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
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
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Timeframe: At prespecified timepoints from Baseline until approximately 5 years
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
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Timeframe: At prespecified timepoints from Baseline until approximately 5 years
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
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Timeframe: At prespecified timepoints from Baseline until approximately 5 years
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
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
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
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
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
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
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
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
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
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
Timeframe: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Timeframe: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Timeframe: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Timeframe: Month 6 and Month 12
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
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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
- Related resource (www.gene.com)
Other registry identifiers
- 2026-526742-27-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Breast neoplasm Primary condition
- Estrogen-receptor positive breast cancer