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NCT Number: NCT07827573

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

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.

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Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Giredestrant

Drug

Participants will receive giredestrant 30 mg orally once a day for up to 5 years.

Other names: RO7197597, GDC-9545, RG6171

Primary outcomes

  1. Incidence of Participants who Have Discontinued Giredestrant for any Reason

    Time frame: Month 12

Secondary outcomes

  1. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to approximately 5 years

  2. Treatment Adherence, as Measured by Dose Intensity

    Time frame: Up to approximately 5 years

  3. Treatment Adherence, as Measured by Treatment Duration

    Time frame: 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)

    Time frame: 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

    Time frame: At prespecified timepoints from Baseline until approximately 5 years

  6. Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES

    Time frame: 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

    Time frame: At prespecified timepoints from Baseline until approximately 5 years

  8. Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES

    Time frame: 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

    Time frame: At prespecified timepoints from Baseline until approximately 5 years

  10. Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Month 6 and Month 12

  21. Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES

    Time frame: Month 6 and Month 12

  22. Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES

    Time frame: Month 6 and Month 12

  23. Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES

    Time frame: 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

    Time frame: 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

    Time frame: Month 6 and Month 12

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: kalitERA

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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