Calendario›PBYI›Alisertib · ALISCA-Breast1
Alisertib · ALISCA-Breast1
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Ensayo de PUMA BIOTECHNOLOGY, INC. en Hormone Receptor Positive HER-2 Negative Breast Cancer · Metastatic Breast Cancer · Recurrent Breast Cancer (del registro, en inglés).
Más ensayos de: Cáncer de mama metastásico.
- Fase
- Fase 2
- Estado
- Reclutando pacientes
- Participantes
- 225
- Centros
- 53
- Fin del objetivo primario
- dic 2027
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2024.
Qué mide
Objective Response Rate (ORR) Within Dose Subgroup (From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Más ensayos de PBYI
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Alisertib · ALISCA-Lung1 | Fase 2 | Reclutando pacientes | oct 2027 (prevista) |
| Alisertib · ALISCA-Lung2 | Fase 2 | Reclutando pacientes | mar 2028 (prevista) |
| Neratinib · SUMMIT | Fase 2 | Interrumpido | ene 2023 (real) |
| Neratinib | Fase 2 | Completado | dic 2021 (real) |
| Neratinib | Fase 2 | Completado | abr 2021 (real) |
| HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib | no aplica | Interrumpido | ene 2021 (real) |
Todos los de PBYI, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06369285), actualizada en sep 2026.