A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
Early Breast Cancer · Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 3800 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
KEY INCLUSION CRITERIA
1. Histologically confirmed unilateral primary adenocarcinoma of the breast
* ER-positive by local assessment
* documented HER2-negative
2. 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:
1. pT4N0 or
2. histologically Grade 3 disease or
3. high-risk classification based on genomic assay
3. Randomization within 16 months of definitive breast surgery
4. If indicated, completed adjuvant and/or neoadjuvant chemotherapy, adjuvant radiation therapy \>/= 21 days prior to randomization
KEY EXCLUSION CRITERIA
1. Distant metastases of breast cancer beyond regional lymph nodes
2. Multicentric or multifocal breast cancer if any tumor foci meet pathologic criteria for ER(-) or HER2(+)
3. Clinically significant cardiovascular disease or cardiac repolarization abnormality for 6 months prior to randomization; resting heart rate \<50bpm
4. 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
5. Prior treatment with investigational product within 30 days or 5 half-lives
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Arm A : Atirmociclib + giredestrant
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day
Drug: Atirmociclib · Drug: giredestrant
Arm B: Placebo for atirmociclib + giredestrant
Placebo atirmociclib tablets given orally twice a day plus giredestrant capsule given once a day
Drug: giredestrant · Other: Atirmociclib placebo
Atirmociclib DRUG
Atirmociclib tablet given orally twice daily, plus giredestrant capsule given orally once per day
giredestrant DRUG
giredestrant capsule given once a day
Atirmociclib placebo OTHER
Atirmociclib placebo tablet given twice a day
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Invasive Breast Cancer Free Survival (iBCFS)
Plazo: 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
Medidas secundarias
Invasive Disease Free Survival (iDFS)
Plazo: 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
Disease Recurrence Free Survival (DRFS)
Plazo: 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
Overall survival (OS)
Plazo: 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
Number and percentage of Participants with Treatment-Emergent Adverse Events (AEs)
Plazo: 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
Percentage of participants With Clinical Laboratory Abnormalities
Plazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
No informado en este registro.
Percentage of Participants With ECG abnormalities
Plazo: From start of treatment until 28 days after last dose of study treatment, up to 5 years
No informado en este registro.
Patient Reported Outcomes (PRO)
Plazo: 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
Pre-dose Plasma Concentration (Ctrough) of atirmociclib
Plazo: Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; Cycle is defined as 28 days
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- Pfizer
- Inicio del estudio
- 1 dic 2026 Estimado
- Finalización primaria
- 13 abr 2032 Estimado
- Finalización del estudio
- 20 ago 2042 Estimado
- Primera publicación
- 22 oct 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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)
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026