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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02338245

NCT02338245
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with breast cancer that has been confirmed by a tissue sample (biopsy), and your cancer tests positive for a protein called HER2 (meaning HER2 is overexpressed or the gene is amplified).
  • You have HER2-positive breast cancer that has spread to other parts of the body (metastatic), and either a previous first-line treatment with a drug called trastuzumab (Herceptin) did not work, or your cancer came back within 1 year of receiving trastuzumab as an early-stage treatment.
  • At least one area of your cancer can be measured on a scan (note: bone-only spread or fluid build-up in the abdomen alone would not count as measurable).
  • You are at or above the legal adult age in your country at the time you sign the consent form.
  • Your organs (such as kidneys and liver) and blood counts are at acceptable levels.

Who may not be able to join:

  • You have had radiation therapy or a major operation within the last 21 days before joining the trial.
  • You have a condition that affects how your body absorbs food or medication, such as problems with your stomach or small intestine, or you have difficulty swallowing and keeping oral medications down.
  • You have an illness that is not well controlled, such as an active infection, unstable chest pain (angina), irregular heartbeat, uncontrolled diabetes, uncontrolled high blood pressure, or a mental health or personal situation that might make it hard to follow the trial requirements.
  • You have had another type of cancer in the past, unless you have been cancer-free for more than 1 year (certain skin cancers and a specific type of early cervical cancer that were fully treated are generally not excluded — confirm with trial site).
  • You have cancer that has spread to your brain and is causing symptoms, or you have taken steroid medications or anti-seizure medications for this reason within the past 3 months.
  • You are currently pregnant or breastfeeding.
  • You have previously been treated with either of the study drugs: ASLAN001 or lapatinib.
  • You have already received more than 2 rounds (lines) of treatment for your metastatic breast cancer.
  • You have taken another experimental drug or used an experimental device within the last 21 days, or received certain antibody-based cancer treatments within a specific timeframe before starting the trial (confirm exact timeframe with trial site).
  • You still have serious, unresolved side effects from a previous experimental drug or cancer treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
ASLAN Pharmaceuticals
Registry
clinicaltrials_gov
Start date
29 December 2014
Est. completion
19 May 2016

Where this trial is recruiting

🇦🇺 Australia Hong Kong 🇳🇿 New Zealand 🇵🇭 Philippines 🇸🇬 Singapore 🇰🇷 South Korea 🇹🇼 Taiwan

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

To compare the efficacy of ASLAN001 in combination with capecitabine, to lapatinib in combination with capecitabine in the percentage change from baseline tumor size at Week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov