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)
tiistai 15. syyskuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
1500
Vaihe
- Vaihe 3
Laajennettu käyttöoikeus
Saatavilla kliinisen tutkimuksen ulkopuolella.
Katso laajennettu käyttöoikeustietue.
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Tutki yhteystietojen varmuuskopiointi
- Nimi: Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
- Puhelinnumero: 888-662-6728 (U.S. Only)
- Sähköposti: global-roche-genentech-trials@gene.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
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Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Muut nimet:
|
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Incidence of Participants who Have Discontinued Giredestrant for any Reason
Aikaikkuna: Month 12
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Month 12
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Incidence and Severity of Adverse Events (AEs)
Aikaikkuna: Up to approximately 5 years
|
Up to approximately 5 years
|
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Treatment Adherence, as Measured by Dose Intensity
Aikaikkuna: Up to approximately 5 years
|
Up to approximately 5 years
|
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Treatment Adherence, as Measured by Treatment Duration
Aikaikkuna: Up to approximately 5 years
|
Up to approximately 5 years
|
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Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Month 6 and Month 12
|
Month 6 and Month 12
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trials, Hoffmann-La Roche
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
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Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
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Ensimmäinen toimitettu, joka täytti QC-kriteerit
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Tutkimustietojen päivitykset
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- BO46775
- 2026-526742-27-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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
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