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

NCT07166367 | Terminated Phase 2

• 1 other identifier: ASLAN001-006
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• CNS objective response rate (ORR) based on RANO-BM criteria

  From start of treatment to date of best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), up to 2 years

Secondary Outcomes (4)

• Safety/toxicity

  The time interval between treatment initiation and progression of disease or death from any cause, up to 2 years

• Clinical benefit rate

  12 weeks from the start of treatment

• Progression free survival

  The time interval between treatment initiation and progression of disease or death from any cause, up to 2 years

• Overall survival

  The time interval between treatment initiation and death from any cause, up to 2 years

Study Arms (1)

ASLAN001 and Capecitabine

EXPERIMENTAL

Drug: ASLAN001; Drug: Capecitabine

Interventions

ASLAN001 DRUG

400mg of Oral ASLAN001 is administered twice daily, every day of each 21-day cycle

Also known as: Varlitinib, ARRY-543

ASLAN001 and Capecitabine

Capecitabine DRUG

1000mg/m\^2 of Oral Capecitabine is administered twice daily, on Days 1-14 of a 21-day cycle

Also known as: Xeloda

ASLAN001 and Capecitabine

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Females with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented histological confirmation of breast cancer with HER-2 overexpression or gene amplification (immunohistochemistry 3+ or immunohistochemistry 2+ with fluorescent / chromogenic / silver in situ hybridization +) prior to study entry.
• Patients with HER-2-positive breast cancer with brain metastasis (BMBC) who received either radiosurgery and/or WBRT and progressing in CNS.
• Presence of more than one radiographically measurable brain metastasis.
• Patients must complete radiation treatment with either whole brain radiotherapy (WBRT) and/or radiosurgery at least 30 days 30 days prior to study entry. (No washout period for other antineoplastic treatment)
• Patients must be of legal age of more than 21 years old at the time of written informed consent.
• Patients of childbearing potential to use adequate contraception prior to, during the study, and 12 weeks after the last dose of therapy.
• Patients able to understand and willing to sign the informed consent form.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Patients with acceptable organ and hematological function:
• Hematological function:
• Absolute neutrophil count ≥1.5 × 10\*\*9/L.
• Platelet count ≥100 × 10\*\*9/L.
• Hemoglobin ≥9 g/L.
• Renal functions:
• \- Serum creatinine ≤1.5 × upper limit of normal (ULN).

You may not qualify if:

• Patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
• Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who are pregnant or breast-feeding.
• Patients who were previously treated with ASLAN001 and/or with lapatinib and/or with capecitabine.
• Patient with known active infection on hepatitis B and hepatitis C and dihydropyrimidine dehydrogenase (DPD) deficiency. (Screening tests not required.)
• Patients with non-measurable disease alone (i.e. leptomeningeal disease)
• Patients who need continuous treatment with proton pump inhibitors during the study period.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yoon Sim Yap

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: August 11, 2016
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

SG (1)