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HER2-positive Breast CancerPhase 2NCT07166367

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

A Phase 2 study testing ASLAN001 and Capecitabine in people with HER2-positive Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
ASLAN001 and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSingapore
Study dates
11 Aug 2016to 14 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Hepatic function:
  • Total bilirubin ≤1.5 × ULN.
  • AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastases are present).

Who cannot join

  • 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 with any history of other malignancy unless in remission for more than 1 year. (Nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary).
  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: 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

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

Read the 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.

Being tested
ASLAN001, Capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASLAN001Drug

    Also called Varlitinib, ARRY-543

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

  • CapecitabineDrug

    Also called Xeloda

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

Study groups in NCT07166367
Study groupRoleWhat they receive
ASLAN001 and CapecitabineExperimentalNot described
Receives: Drug: ASLAN001; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

  1. Safety/toxicity

    Events with CTCAE grades of 1 and above.

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

  2. Clinical benefit rate

    The sum of complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks

    Measured: 12 weeks from the start of treatment

  3. Progression free survival

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

  4. Overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start11 Aug 2016
  3. Primary completion14 Jan 2020
  4. Study completion14 Jan 2020

Why it stopped: Difficulty in enrolling patients with the illness under study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166367
Sponsor's protocol ID
ASLAN001-006
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASLAN001 and Capecitabine in people with HER2-positive Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulty in enrolling patients with the illness under study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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