HER2 Positive Metastatic Breast CancerPhase 1/2NCT02422199
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
A Phase 1/2 study testing pyrotinib, Lapatinib and capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Positive Metastatic Breast Cancer
- What is being tested?
- pyrotinib, Lapatinib and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- May 2015to Dec 2018
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- At least one measurable lesion exists.(RECIST 1.1).
- Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
- Required laboratory values including following parameters:
- ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- Signed informed consent
Who cannot join
- Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
- Received previous therapy with capecitabine within 3 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
307 Hospital Affiliated to Academy Military Medical Science
Beijing
About this study
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:
- Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)
- Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
- Conditions
- HER2 Positive Metastatic Breast Cancer
- Being tested
- pyrotinib, Lapatinib, capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
LapatinibDrug
capecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib plus capecitabine | Experimental | pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) Receives: Drug: pyrotinib; Drug: capecitabine |
| lapatinib plus capecitabine | Active comparator | lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) Receives: Drug: Lapatinib; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Measured: : From consent through 28 days following treatment completion (estimated 18 months)
Objective Response Rate (ORR)
Measured: Estimated 12 months
Secondary outcomes (3)
Progression Free Survival (PFS)
Measured: Estimated 18 months
Time to Progression (TTP)
Measured: Estimated 18 months
Duration of Response (DOR)
Measured: Estimated 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422199
- Sponsor's protocol ID
- HR-BLTN-I/II-MBC
- Status last verified
- Jul 2018
- First submitted
- 16 Apr 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bao Y, Zhang Z, He X, Cai L, Wang X, Li X. Cost-Effectiveness of Pyrotinib Plus Capecitabine versus Lapatinib Plus Capecitabine for the Treatment of HER2-Positive Metastatic Breast Cancer in China: A Scenario Analysis of Health Insurance Coverage. Curr Oncol. 2022 Aug 23;29(9):6053-6067. doi: 10.3390/curroncol29090476.
PubMed 36135045
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
- ClinicalTrials.gov ID
- NCT02422199
- Acronym / sponsor ID
- HR-BLTN-I/II-MBC
- Conditions
- HER2 Positive Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Apr 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.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:
- Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)
- Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pyrotinib plus capecitabine | Experimental | Drug: pyrotinib, Drug: capecitabinepyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) |
| lapatinib plus capecitabine | Active comparator | Drug: Lapatinib, Drug: capecitabinelapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- At least one measurable lesion exists.(RECIST 1.1).
- Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
Key exclusion criteria (2 listed)
- Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
- Received previous therapy with capecitabine within 3 months.
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 |
|---|---|---|
| pyrotinib | Drug | pyrotinib plus capecitabine |
| Lapatinib | Drug | lapatinib plus capecitabine |
| capecitabine | Drug | lapatinib plus capecitabine, pyrotinib plus capecitabine |
Primary outcome
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Time frame: : From consent through 28 days following treatment completion (estimated 18 months)
Objective Response Rate (ORR)
Time frame: Estimated 12 months
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: Estimated 18 months
Time to Progression (TTP)
Time frame: Estimated 18 months
Duration of Response (DOR)
Time frame: Estimated 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Derived from this study: PubMed 36135045Bao Y, Zhang Z, He X, Cai L, Wang X, Li X. Cost-Effectiveness of Pyrotinib Plus Capecitabine versus Lapatinib Plus Capecitabine for the Treatment of HER2-Positive Metastatic Breast Cancer in China: A Scenario Analysis of Health Insurance Coverage. Curr Oncol. 2022 Aug 23;29(9):6053-6067. doi: 10.3390/curroncol29090476.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pyrotinib, Lapatinib and capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) (time frame: : From consent through 28 days following treatment completion (estimated 18 months)). The study lists 2 primary outcomes in all. 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 NCT02422199, which also lists 1 linked publication.
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 9 Jul 2018.