Early Breast CancerPhase 3kalitERANCT07827573
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 3 study testing Giredestrant in people with Early Breast Cancer and Estrogen Receptor-Positive Breast Cancer, run by Hoffmann-La Roche.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- What is being tested?
- Giredestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Nov 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
About this study
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
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
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Being tested
- Giredestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiredestrantDrug
Also called RO7197597, GDC-9545, RG6171
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Upfront Adjuvant Endocrine Therapy Population | Experimental | Participants will receive giredestrant. Receives: Drug: Giredestrant |
| Cohort B: Switch Adjuvant Endocrine Therapy Population | Experimental | Participants will receive giredestrant. Receives: Drug: Giredestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Measured: Month 12
Secondary outcomes (39)
Incidence and Severity of Adverse Events (AEs)
Measured: Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Measured: Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Measured: 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)
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Measured: 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
Measured: 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
Measured: 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 Interference Composite Score
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
Measured: Month 6 and Month 12
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
Measured: At prespecified timepoints from Baseline until approximately 5 years
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
Measured: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827573
- Sponsor's protocol ID
- BO46775
- Other IDs
- 2026-526742-27-00
- Acronym
- kalitERA
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
- Expanded access
- Available