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)
15. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1500
Fase
- Fase 3
Udvidet adgang
Ledig uden for det kliniske forsøg.
Se udvidet adgangsregistrering.
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Undersøgelse Kontakt Backup
- Navn: Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Andre navne:
|
|
Eksperimentel: Cohort B: Switch Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Tidsramme: Month 12
|
Month 12
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Tidsramme: Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Dose Intensity
Tidsramme: Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Treatment Duration
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Month 6 and Month 12
|
Month 6 and Month 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. oktober 2026
Primær færdiggørelse (Anslået)
30. november 2028
Studieafslutning (Anslået)
30. november 2032
Datoer for studieregistrering
Først indsendt
15. september 2026
Først indsendt, der opfyldte QC-kriterier
15. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BO46775
- 2026-526742-27-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .