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 (kalitERA)

September 15, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
Drug: Giredestrant
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Other Names:
  • GDC-9545
  • RO7197597
  • RG6171
Experimental: Cohort B: Switch Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
Drug: Giredestrant
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Other Names:
  • GDC-9545
  • RO7197597
  • RG6171

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Time Frame: Up to approximately 5 years
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)
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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)
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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)
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
Time Frame: At prespecified timepoints from Baseline until approximately 5 years
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
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
Time Frame: Month 6 and Month 12
Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2032

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO46775
  • 2026-526742-27-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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