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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Pfizer CT.gov Call Center
- Telefonní číslo: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
-
If indicated, completed adjuvant and/or neoadjuvant chemotherapy, adjuvant radiation therapy >/= 21 days prior to randomization
KEY EXCLUSION CRITERIA
-
Distant metastases of breast cancer beyond regional lymph nodes
-
Multicentric or multifocal breast cancer if any tumor foci meet pathologic criteria for ER(-) or HER2(+)
-
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
Ostatní jména:
giredestrant capsule given once a day |
|
Aktivní komparátor: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Invasive Breast Cancer Free Survival (iBCFS)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Invasive Disease Free Survival (iDFS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C4391026
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu 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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