NCT07166367

Phase II Study to Assess the Efficacy of ASLAN001 Plus Capecitabine in CNS Metastases for HER2+ Breast Cancer

A Phase II Single Arm Trial to Assess the Efficacy of ASLAN001 Plus Capecitabine in Previously Irradiated, Progressing Central Nervous System (CNS) Metastases for HER2 Positive Breast Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to study the efficacy of ASLAN 001 plus capecitabine for previously irradiated, progressing CNS metastases for HER2+ breast cancer patients.

Detailed description

Brain metastasis in breast cancer (BMBC) has very poor prognosis. The focus for this group of patients is on palliation as well as therapeutics that offer meaningful clinical benefits. Treatment options generally involve local control using either whole brain radiotherapy (WBRT) or neurosurgery/radiosurgery or combination of both. Subsequent to local treatment, systemic control can be re-initiated via systemic chemotherapy/targeted therapies or trial participation. This is a single arm, single center, phase 2 study. A total of 29 eligible HER2 positive breast cancer patients with irradiated, progressing brain metastasis will be enrolled to receive ASLAN001 400 mg orally BID with capecitabine 1000 mg/m2 orally BID for days 1-14 of a 21-day cycle. Treatment will continue until disease progression or unacceptable toxicity. Baseline brain imaging using either magnetic resonance imaging (MRI) or computed tomography (CT) scans will be performed; non-brain imaging will also be performed in the same settings. Radiological imaging to assess disease status will be performed at baseline and every 2 cycles until disease progression.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	ASLAN001	400mg of Oral ASLAN001 is administered twice daily, every day of each 21-day cycle
DRUG	Capecitabine	1000mg/m\^2 of Oral Capecitabine is administered twice daily, on Days 1-14 of a 21-day cycle

Timeline

• Start date: 2016-08-11
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: Singapore