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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. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

1500

Fáze

  • Fáze 3

Rozšířený přístup

Dostupný mimo klinické hodnocení. Viz rozšířený záznam o přístupu.

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

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

Studijní záloha kontaktů

  • Jméno: Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
  • Telefonní číslo: 888-662-6728 (U.S. Only)
  • E-mail: global-roche-genentech-trials@gene.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Ostatní jména:
  • GDC-9545
  • RO7197597
  • RG6171
Experimentální: 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.
Ostatní jména:
  • GDC-9545
  • RO7197597
  • RG6171

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Časové okno: Month 12
Month 12

Sekundární výstupní opatření

Měření výsledku
Časové okno
Incidence and Severity of Adverse Events (AEs)
Časové okno: Up to approximately 5 years
Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Časové okno: Up to approximately 5 years
Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 6 and Month 12
Month 6 and Month 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Ředitel studie: Clinical Trials, Hoffmann-La Roche

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. října 2026

Primární dokončení (Odhadovaný)

30. listopadu 2028

Dokončení studie (Odhadovaný)

30. listopadu 2032

Termíny zápisu do studia

První předloženo

15. září 2026

První předloženo, které splnilo kritéria kontroly kvality

15. září 2026

První zveřejněno (Aktuální)

18. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .