Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer

Summary

This phase I/Ib trial tests the safety, side effects, best dose, and effectiveness of ASTX660 (tolinapant) in combination with eribulin mesylate (eribulin) in treating patients with triple negative breast cancer that cannot be removed by surgery (unresectable) or that has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, needed for tumor cell survival. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tolinapant in combination with eribulin may be safe, tolerable, and/or effective in treating patients with unresectable, locally advanced, or metastatic triple negative breast cancer.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Locally Advanced HER2-Negative Breast Carcinoma
• Locally Advanced Hormone Receptor-Positive Breast Carcinoma
• Locally Advanced Triple-Negative Breast Carcinoma
• Metastatic HER2-Negative Breast Carcinoma
• Metastatic Hormone Receptor-Positive Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Unresectable HER2-Negative Breast Carcinoma
• Unresectable Hormone Receptor-Positive Breast Carcinoma
• Unresectable Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Eribulin Mesylate

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Tolinapant

Given PO

PROCEDURE

X-Ray Imaging

Undergo chest X-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kristen Kelley · Ohio State University Comprehensive Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-04

Primary Completion

2027-05-17

Completion

2027-05-17

FDA Drug

Yes