Breast CancerPhase 2NCT03923179
Phase II Clinical Study of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer
A Phase 2 study testing Pyrotinib and Etoposide in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2019to 31 Dec 2021
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age：18~75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- A life expectancy of more than 12 weeks;
- patients have at least one measurable lesion exists according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and progresses after the last anti-tumor treatment or during treatment;
- Pathologically confirmed HER2-expressing patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
- Progression after treatment with trastuzumab or treatment, patients who are no longer able to receive trastuzumab or lapatinib: continuous use of trastuzumab ≥ 2 cycles during relapse/metastasis Or during the adjuvant treatment, continuous use of trastuzumab ≥ 3 months, recurrence / metastasis after treatment or treatment;
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- echocardiography indicates that LVEF ≥ 50%;
- The laboratory tests confirmed that the bone marrow function and liver and kidney function of the patient met the following requirements before the first dose:
- ANC≥1.5×10^9/L；
- PLT≥100×10^9/L;
- Hb≥100 g/L
- serum creatinine(Scr) less than 1.5 times the upper limit of normal value or the creatinine clearance rate calculated greater than 60 mL/min;
- total bilirubin less than 1.5 times the upper limit of normal value
- aspartate aminotransferase (AST), or alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases;
- urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
- Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, and they are willing to take effective contraceptive methods during the trial;
- The patient volunteered to join the study and signed an informed consent form.
Who cannot join
- Previously treated with pyrrolidine or neratinib;
- Previously received etoposide treatment;
- Patients with high blood pressure who are not well controlled by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as within 6 months before screening Refractory angina pectoris, congestive heart failure occurred; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, QT interval prolongation; history of cerebrovascular accident, symptomatic and need Medically treated coronary heart disease;
- having significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Refractory, 2 degrees and above persistent diarrhea;
- exiting unstable brain metastasis and / or meningeal metastasis;
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- Have undergone major surgery or severe traumatic injury, fracture, or healed wound within 4 weeks;
- Allergic to pyrotinib, etoposide and/or its excipients has been confirmed;
- Female patients during pregnancy or lactation, female patients with fertility and positive pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
- The patient has a severe concomitant disease, or any other condition that the investigator believes is not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, 100021
Qiao I Li, 8687788120 ext. 8687788120, Liqiaopumc@qq.com
About this study
Official title: The Efficacy and Safety of Pyrotinib Combined With Etoposide in HER2-positive Advanced Breast Cancer
The purpose of this study is to assess the efficacy and safety of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib, Etoposide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Pyrotinib, 400mg qd
EtoposideDrug
Etoposide, 50mg，qd,d1-21,Q4W
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib+Etoposide | Experimental | Not described Receives: Drug: Pyrotinib; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
Measured: 4 months
Secondary outcomes (2)
Progression Free Survival(PFS)
the date from the first dose to the first occurrence of disease progression or death from any cause, whichever occurs first
Measured: 4 months
disease control rate(DCR)
Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start19 Apr 2019 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion31 Dec 2021 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Qiao, Chinese Academy of Medical Sciences
- Investigators
- Qiao I Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesBinghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923179
- Sponsor's protocol ID
- LQ007
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, He M, Jiang M, Zhou S, Zhang M, Li Y, Chen S, Cai R, Mo H, Lan B, Ma F, Xu B, Li Q. Pyrotinib combined with metronomic etoposide in heavily pretreated HER2-positive metastatic breast cancer: a single-arm, phase II study. BMC Cancer. 2024 Oct 18;24(1):1290. doi: 10.1186/s12885-024-13041-8.
PubMed 39425028
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pyrotinib Combined With Etoposide in HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03923179
- Acronym / sponsor ID
- LQ007
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 19 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Apr 2019 (actual)
- 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.
The purpose of this study is to assess the efficacy and safety of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pyrotinib+Etoposide | Experimental | Drug: Pyrotinib, Drug: Etoposide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age：18~75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- A life expectancy of more than 12 weeks;
- patients have at least one measurable lesion exists according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and progresses after the last anti-tumor treatment or during treatment;
- Pathologically confirmed HER2-expressing patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
Key exclusion criteria (10 listed)
- Previously treated with pyrrolidine or neratinib;
- Previously received etoposide treatment;
- Patients with high blood pressure who are not well controlled by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as within 6 months before screening Refractory angina pectoris, congestive heart failure occurred; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, QT interval prolongation; history of cerebrovascular accident, symptomatic and need Medically treated coronary heart disease;
- having significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Refractory, 2 degrees and above persistent diarrhea;
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 |
|---|---|---|
| PyrotinibPyrotinib, 400mg qd | Drug | pyrotinib+Etoposide |
| EtoposideEtoposide, 50mg，qd,d1-21,Q4W | Drug | pyrotinib+Etoposide |
Primary outcome
Objective Response Rate(ORR)
Time frame: 4 months
Refers to the proportion of patients whose tumors have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
2 secondary outcomes
Progression Free Survival(PFS)
Time frame: 4 months
disease control rate(DCR)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 39425028Liu J, He M, Jiang M, Zhou S, Zhang M, Li Y, Chen S, Cai R, Mo H, Lan B, Ma F, Xu B, Li Q. Pyrotinib combined with metronomic etoposide in heavily pretreated HER2-positive metastatic breast cancer: a single-arm, phase II study. BMC Cancer. 2024 Oct 18;24(1):1290. doi: 10.1186/s12885-024-13041-8.
- Individual participant dataSharing planned: Undecided
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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.
Qiao I Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib and Etoposide in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site 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 17 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe I Xu (8687788826 ext. 8687788826, xubinghe@medmall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: 4 months). 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 NCT03923179, 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 22 Apr 2019.