This study is designed to study the efficacy of ASLAN 001 plus capecitabine for previously irradiated, progressing CNS metastases for HER2+ breast cancer patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
400mg of Oral ASLAN001 is administered twice daily, every day of each 21-day cycle
1000mg/m\^2 of Oral Capecitabine is administered twice daily, on Days 1-14 of a 21-day cycle
National Cancer Centre Singapore
Singapore, Singapore
CNS objective response rate (ORR) based on RANO-BM criteria
Time frame: From start of treatment to date of best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), up to 2 years
Safety/toxicity
Events with CTCAE grades of 1 and above.
Time frame: The time interval between treatment initiation and progression of disease or death from any cause, up to 2 years
Clinical benefit rate
The sum of complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks
Time frame: 12 weeks from the start of treatment
Progression free survival
Time frame: The time interval between treatment initiation and progression of disease or death from any cause, up to 2 years
Overall survival
Time frame: The time interval between treatment initiation and death from any cause, up to 2 years
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