Trial Profile

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 04 Aug 2026

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At a glance

Drugs Alisertib (Primary) ; Anastrozole; Antineoplastics; Exemestane; Fulvestrant; Letrozole; Tamoxifen
Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Adverse reactions; Therapeutic Use
Acronyms ALISCA-Breast1
Sponsors Puma Biotechnology

Most Recent Events

27 Jul 2026 Planned number of patients changed from 150 to 225.
27 Jul 2026 Planned End Date changed from 31 Dec 2028 to 30 Jun 2029.
27 Jul 2026 Planned primary completion date changed from 30 Jun 2027 to 30 Dec 2027.

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