A Study of Alisertib in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1)

Puma Biotechnology

Status and phase: Enrolling; Phase 2

Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

Treatments: Drug: Alisertib; Drug: Endocrine therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06369285

2024-511497-79-00

PUMA-ALI-1201

Details and patient eligibility

About

PUMA-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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years at signing of informed consent.
• Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.
• Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
• Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
• HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines:

Exclusion criteria

• Treatment with chemotherapy in the recurrent or metastatic setting.
• Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Alisertib 50 mg

Experimental group

Description:

Alisertib with selected endocrine therapy

Treatment:

Drug: Endocrine therapy

Drug: Alisertib

Alisertib 40 mg

Experimental group

Description:

Alisertib with selected endocrine therapy

Treatment:

Drug: Endocrine therapy

Drug: Alisertib

Alisertib 30 mg

Experimental group

Description:

Alisertib with selected endocrine therapy

Treatment:

Drug: Endocrine therapy

Drug: Alisertib