A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
AN INTERVENTIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF ATIRMOCICLIB (PF-07220060) PLUS GIREDESTRANT COMPARED TO GIREDESTRANT MONOTHERAPY AS ADJUVANT TREATMENT IN ADULT PARTICIPANTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE, HER2-NEGATIVE EARLY-STAGE BREAST CANCER WITH MEDIUM OR HIGH RISK OF RECURRENCE (FOURLIGHT-4)
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or high risk of recurrence.
This is a Phase 3, double blind, placebo controlled study of atirmociclib plus giredestrant vs. giredestrant monotherapy as adjuvant treatment in adult patients with ER+, HER2- early breast cancer. The study plans to enroll 3800 participants randomized 1:1 into one of two treatment arms (Arm A - investigational: atirmociclib plus giredestrant taken continuously in a 28-day cycle) or (Arm B - comparator: placebo plus giredestrant taken continuously in a 28-day cycle). Participants may be treated with atirmociclib/placebo up to 3 years and giredestrant up to 5 years followed by long term follow up for survival and evaluation of recurrence of disease.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
KEY INCLUSION CRITERIA
-
Histologically confirmed unilateral primary adenocarcinoma of the breast
- ER-positive by local assessment
- documented HER2-negative
-
Node positive or node negative as defined by:
-
Pathological node positive (microscopic and/or macroscopic tumor involvement >/=pN1)
-
pN0 and pT >1cm with at least one of the following:
- pT4N0 or
- histologically Grade 3 disease or
- high-risk classification based on genomic assay
-
-
Randomization within 16 months of definitive breast surgery
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If indicated, completed adjuvant and/or neoadjuvant chemotherapy, adjuvant radiation therapy >/= 21 days prior to randomization
KEY EXCLUSION CRITERIA
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Distant metastases of breast cancer beyond regional lymph nodes
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Multicentric or multifocal breast cancer if any tumor foci meet pathologic criteria for ER(-) or HER2(+)
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Clinically significant cardiovascular disease or cardiac repolarization abnormality for 6 months prior to randomization; resting heart rate <50bpm
-
Has received the following prior systemic anti-cancer therapy for breast cancer
- prior atirmociclib, giredestrant, other investigational anti-cancer agent
- prior treatment with olaparib
NOTES:
- short course of prior neo/adjuvant CDK4/6 inhibitor treatment (</=8 weeks) is permitted; 10-day washout period required
- short course of prior neoadjuvant and/or adjuvant ET (</=18 weeks) is permitted; 35-day washout period for tamoxifen is required
-
Prior treatment with investigational product within 30 days or 5 half-lives
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Arm A : Atirmociclib + giredestrant
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day |
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day
Altri nomi:
giredestrant capsule given once a day |
|
Comparatore attivo: Arm B: Placebo for atirmociclib + giredestrant
Placebo atirmociclib tablets given orally twice a day plus giredestrant capsule given once a day |
giredestrant capsule given once a day Atirmociclib placebo tablet given twice a day |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Invasive Breast Cancer Free Survival (iBCFS)
Lasso di tempo: From randomization to first iBCFS event, up to 16 years
|
iBCFS is defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iBCFS event, up to 16 years
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Invasive Disease Free Survival (iDFS)
Lasso di tempo: From randomization to first iDCFS event, up to 16 years
|
iDFS defined as the time from the date of randomization to the date of first documented occurrence of invasive ipsilateral breast tumor recurrence, local-regional invasive breast cancer recurrence, invasive contralateral breast cancer, distant recurrence, second primary invasive non-breast cancer, or death from any cause, as determined by investigator assessment per STEEP v2.0 criteria |
From randomization to first iDCFS event, up to 16 years
|
|
Disease Recurrence Free Survival (DRFS)
Lasso di tempo: From randomization to first DRFS event, up to 16 years
|
DRFS as per investigator assessment, defined as the time from the date of randomization to the date of distant recurrence as determined by investigator assessment or death from any cause, whichever occurs first |
From randomization to first DRFS event, up to 16 years
|
|
Overall survival (OS)
Lasso di tempo: From randomization to death from any cause, up to 16 years
|
OS is defined as the time from the date of randomization to the date of death due to any cause |
From randomization to death from any cause, up to 16 years
|
|
Number and percentage of Participants with Treatment-Emergent Adverse Events (AEs)
Lasso di tempo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Type, incidence, severity of AE graded by NCI CTCAE v 5.0, seriousness and relationship to study intervention |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Percentage of participants With Clinical Laboratory Abnormalities
Lasso di tempo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Percentage of Participants With ECG abnormalities
Lasso di tempo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
|
Patient Reported Outcomes (PRO)
Lasso di tempo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
Change from baseline in participant reported total score, well-being subscales and symptoms scores and TOI per FACT-ES |
From start of treatment until 28 days after last dose of study treatment, up to 5 years
|
|
Pre-dose Plasma Concentration (Ctrough) of atirmociclib
Lasso di tempo: Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- C4391026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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