Metastatic Breast CancerPhase 2NCT02338245
Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab
A Phase 2 study testing ASLAN001, Lapatinib and Capecitabine in people with Metastatic Breast Cancer, run by ASLAN Pharmaceuticals at 19 sites in 7 countries.
Trial summary
This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- ASLAN001, Lapatinib and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 29 Dec 2014to 25 Aug 2016
- 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 18 years and older
- 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 prior to study entry.
- Patients with HER 2-positive metastatic breast cancer that have failed on prior first line treatment with trastuzumab or who have progressed within 1 year of treatment with trastuzumab in adjuvant setting.
- Presence of at least one radiographically measurable disease (bone metastases and ascites are not considered measurable lesions).
- Patients of the respective country's legal age or older at the time of written informed consent.
- Patients with acceptable organ and hematological function
Who cannot join
- Patients with radiation treatment or major surgical procedures within 21 days prior to study entry.
- 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 with symptomatic central nervous system metastasis and/or on systemic steroids or anticonvulsants within 3 months before the first dose of randomized therapy.
- Patients who are pregnant or breast-feeding.
Show all 10Show fewer
- Patients who were previously treated with ASLAN001 and/or with lapatinib.
- Patients who have received more than 2 lines of any therapies in metastatic stage.
- Patients who have received any investigational drug (or have used an investigational device) within 21 days or received any antineoplastic monoclonal antibodies within a period of 5 half-lives before receiving the first dose of randomized therapy.
- Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
Taiwan7 sites
Taiwan
Kaohsiung City, 833
Taiwan
Linkou District, Taoyuan, 333
Taiwan
Taichung, 40447
Taiwan
Taipei, 10449
Taiwan
Taipei, 10507
Taiwan
Taipei, 112
Taiwan
Taipei, 114
South Korea4 sites
South Korea
Seoul, 110-744
South Korea
Seoul, 135-710
South Korea
Seoul, 137-701
South Korea
Seoul, 138-736
New Zealand2 sites
New Zealand
Christchurch, 8140
New Zealand
Tauranga, 3143
About this study
Official title: Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy
This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.
Read the detailed description
Phase 2A Design:
The Phase 2A part is an open-label, randomized, parallel group study using tumor size as its primary efficacy endpoint. Approximately 44 eligible patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg orally twice daily (BID) or lapatinib 1250 mg orally once daily (QD), both on a background of capecitabine 1000 mg/m2 orally BID for Days 1-14 of a 21-day cycle. Radiological imaging to assess disease status will be performed at baseline and every 6 weeks until disease progression (as assessed by the Investigator). Patients who have not experienced disease progression after 12 weeks may continue to receive randomized therapy and will continue to have radiological scans every 6 weeks until disease progression.
Criteria to Proceed to Phase 2B:
In the absence of any safety or tolerability concerns, continuation to the Phase 2B part of the study will be primarily based on the statistical comparison of the percentage change in tumor size from baseline to Week 12 and a one-sided p-value <0.1 in favor of the ASLAN001-containing treatment arm would be supportive of continuation to Phase 2B.
Phase 2B Design:
The Phase 2B part of the study will continue to recruit if the pre-specified efficacy criteria are met in the Phase 2A part and if the tolerability of ASLAN001 in combination with capecitabine is considered acceptable.
The Phase 2B part is an open-label, randomized, parallel group study. In this part, approximately 160 patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg BID or lapatinib 1250 mg QD, both in combination with capecitabine 1000 mg/m2 BID for Days 1-14 of a 21-day cycle.
- Conditions
- Metastatic Breast Cancer
- Being tested
- ASLAN001, Lapatinib, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASLAN001Drug
ASLAN001 400mg BID
LapatinibDrug
Also called Tykerb
Lapatinib 1250mg QD
CapecitabineDrug
Also called Xeloda
Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | ASLAN001 + Capecitabine Receives: Drug: ASLAN001; Drug: Capecitabine |
| Treatment Arm B | Active comparator | Lapatinib + Capecitabine Receives: Drug: Lapatinib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (3)
Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events)
Physical exam, body weight, vital signs (Blood pressure, respiratory rate and body temperateure), ECG parameter, hematology, clinical laboratory tests (clinical chemistry, coagulation and urinalysis) and Adverse Events (AEs)/ Serious Adverse Events (SAEs)
Measured: estimated 2 years
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by PFS and tumor volume
Measured: Week 12
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by the Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS)
Composite outcome measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start29 Dec 2014
- Primary completion19 May 2016
- Study completion25 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338245
- Sponsor's protocol ID
- ASLAN001-003
- Status last verified
- Oct 2017
- First submitted
- 6 Jan 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy
- ClinicalTrials.gov ID
- NCT02338245
- Acronym / sponsor ID
- ASLAN001-003
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Study start
- 29 Dec 2014 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 25 Aug 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.
Detailed description
Phase 2A Design:
The Phase 2A part is an open-label, randomized, parallel group study using tumor size as its primary efficacy endpoint. Approximately 44 eligible patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg orally twice daily (BID) or lapatinib 1250 mg orally once daily (QD), both on a background of capecitabine 1000 mg/m2 orally BID for Days 1-14 of a 21-day cycle. Radiological imaging to assess disease status will be performed at baseline and every 6 weeks until disease progression (as assessed by the Investigator). Patients who have not experienced disease progression after 12 weeks may continue to receive randomized therapy and will continue to have radiological scans every 6 weeks until disease progression.
Criteria to Proceed to Phase 2B:
In the absence of any safety or tolerability concerns, continuation to the Phase 2B part of the study will be primarily based on the statistical comparison of the percentage change in tumor size from baseline to Week 12 and a one-sided p-value <0.1 in favor of the ASLAN001-containing treatment arm would be supportive of continuation to Phase 2B.
Phase 2B Design:
The Phase 2B part of the study will continue to recruit if the pre-specified efficacy criteria are met in the Phase 2A part and if the tolerability of ASLAN001 in combination with capecitabine is considered acceptable.
The Phase 2B part is an open-label, randomized, parallel group study. In this part, approximately 160 patients will be randomized in a 1:1 ratio to receive either ASLAN001 400 mg BID or lapatinib 1250 mg QD, both in combination with capecitabine 1000 mg/m2 BID for Days 1-14 of a 21-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: ASLAN001, Drug: CapecitabineASLAN001 + Capecitabine |
| Treatment Arm B | Active comparator | Drug: Lapatinib, Drug: CapecitabineLapatinib + Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with documented histological confirmation of breast cancer with HER 2 overexpression or gene amplification prior to study entry.
- Patients with HER 2-positive metastatic breast cancer that have failed on prior first line treatment with trastuzumab or who have progressed within 1 year of treatment with trastuzumab in adjuvant setting.
- Presence of at least one radiographically measurable disease (bone metastases and ascites are not considered measurable lesions).
- Patients of the respective country's legal age or older at the time of written informed consent.
- Patients with acceptable organ and hematological function
Key exclusion criteria (10 listed)
- Patients with radiation treatment or major surgical procedures within 21 days prior to study entry.
- 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 with symptomatic central nervous system metastasis and/or on systemic steroids or anticonvulsants within 3 months before the first dose of randomized therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASLAN001ASLAN001 400mg BID | Drug | Treatment Arm A |
| LapatinibAlso: TykerbLapatinib 1250mg QD | Drug | Treatment Arm B |
| CapecitabineAlso: XelodaCapecitabine 1000mg/kg BID days 1-14 of a 21-day cycle | Drug | Treatment Arm A, Treatment Arm B |
Primary outcome
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
Time frame: Week 12
3 secondary outcomes
Safety for all metastatic breast cancer (MBC) subjects (Physical examination, body weight, vital signs, ECG parameter, hematology, clinical laboratory tests and Adverse Events)
Time frame: estimated 2 years
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by PFS and tumor volume
Time frame: Week 12
To further compare the efficacy of ASLAN001 in combination with capecitabine to lapatinib in combination with capecitabine, as measured by the Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASLAN001, Lapatinib and Capecitabine in people with Metastatic Breast Cancer, run by ASLAN Pharmaceuticals at 19 sites in 7 countries.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Taiwan, South Korea, New Zealand, Philippines, Singapore and 2 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2017.