Breast CancerPhase 2PyrotinibNCT03933982
A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
A Phase 2 study testing Pyrotinib Plus Vinorelbine in people with Breast Cancer and Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic 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, Brain Metastases
- What is being tested?
- Pyrotinib Plus Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2018to 22 Jun 2022
- 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
- Age18-75 years.
- ECOG performance status ≤2.
- Histologically confirmed HER2 positive advanced breast cancer.
- Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
- Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
- Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
- Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
- Signed the informed consent form prior to patient entry.
Who cannot join
- Participated in other drug clinical trials within 4 weeks before the start of the study;
- Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
- Received endocrine therapy within 7 days before the start of the study;
- Suitable for surgical resection;
- Accompanied by rapid progress of organ invasion;
- Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
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- Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
- Allergies to any compounds of experimental drugs;
- CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
- Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
- Any other situations judged by investigator as not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Peng Yuan, M.D., +8613501270834, yuanpeng01@hotmail.com
+8615652632903, yuanpeng01@hotmail.com
About this study
Official title: Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- Pyrotinib Plus Vinorelbine
- Keywords
- Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib Plus VinorelbineDrug
Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib plus Vinorelbine | Experimental | Not described Receives: Drug: Pyrotinib Plus Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) of CNS
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
Measured: Estimated up to 1 year
Secondary outcomes (3)
Time to progression (TTP)
TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first.
Measured: Estimated up to 1 year
OS (overall survival)
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Measured: Estimated up to 1 year
Time to radiotherapy
Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.
Measured: Estimated up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start22 Dec 2018
- Primary completion22 Dec 2021 (estimated)
- Study completion22 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, M.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933982
- Sponsor's protocol ID
- NCC1865
- Acronym
- Pyrotinib
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
- ClinicalTrials.gov ID
- NCT03933982
- Acronym / sponsor ID
- Pyrotinib / NCC1865
- Conditions
- Breast Cancer, Brain Metastases
- Keywords
- Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 22 Dec 2021 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 1 May 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.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic 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 plus Vinorelbine | Experimental | Drug: Pyrotinib Plus Vinorelbine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age18-75 years.
- ECOG performance status ≤2.
- Histologically confirmed HER2 positive advanced breast cancer.
- Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
- Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
Key exclusion criteria (11 listed)
- Participated in other drug clinical trials within 4 weeks before the start of the study;
- Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
- Received endocrine therapy within 7 days before the start of the study;
- Suitable for surgical resection;
- Accompanied by rapid progress of organ invasion;
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 Plus VinorelbinePyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day. | Drug | Pyrotinib plus Vinorelbine |
Primary outcome
Objective Response Rate (ORR) of CNS
Time frame: Estimated up to 1 year
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
3 secondary outcomes
Time to progression (TTP)
Time frame: Estimated up to 1 year
OS (overall survival)
Time frame: Estimated up to 1 year
Time to radiotherapy
Time frame: Estimated up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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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.
Peng Yuan, M.D. study chair
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 Plus Vinorelbine in people with Breast Cancer and Brain Metastases, 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 8 inclusion and 11 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 29 May 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 Peng Yuan, M.D. (+8613501270834, yuanpeng01@hotmail.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) of CNS (time frame: Estimated up to 1 year). 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 29 May 2019.