Breast CancerPhase 2NCT04639271
Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
A Phase 2 study testing Pyrotinib Plus And, Trastuzumab and Abraxane in people with Breast Cancer and HER2-positive Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib Plus And, Trastuzumab and Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Mar 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
- Aged >18 years.
- ECOG performance status ≤2.
- Histologically or cytologic confirmed HER2 positive advanced breast cancer.
- MRI confirmed brain metastases. According to RECIST 1.1, at least one measurable lesion exists.
- No limit of previous chemotherapy lines.
- Previously have not reveived capecitabine or disease progression of capecitabine after 6 months, or progression of capecitabine adjuvant therapy after one year;
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- Life expectancy of more than 3 months.
- 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 (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- Signed the informed consent form prior to patient entry.
Who cannot join
- Patients with brain metastases who have extensive meningeal metastases and are treated with hormone dehydration.
- Subjects with third space fluid(such as a large amount of pleural effusion and ascites) that can not be controled by drainage or other methods. (such as pleural effusion and ascites).
- Received whole brain radiotherapy, chemotherapy, surgery or target therapy within 2 weeks prior to randomization. Received hormone therapy within 1 weeks prior to randomization, Received the nitrosoureas or mitomycin chemotherapy within 6 weeks prior to randomization.
- Participated in other clinical trial within 4 weeks prior to randomization.
- Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) (including Lapatinib, Neratinib and Pyrotinib).
- Second malignancies within 5 years, except for cured carcinoma in-situ of uterine cervix, skin basal cell carcinomaand squamous-cell carcinoma.
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- Receiving any other anti-tumor therapies at time of study screening visit.
- There are no other serious and/or uncontrolled diseases that may affect research participation, including any of the following: (1) unable to swallow, chronic diarrhea and intestinal obstruction and factors influencing the usage of oral administration; (2) has allergies or a known history of hypersensitivity to the drug components of this program; History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation; (3) History of any kind of Heart disease, including 1) Myocardial infarction; 2) Heart failure; 3) Any other heart disease judged by researcher as not suitable for participating in this study, etc; (4) Infection.
- All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study.
- Any other situations judged by investigator as not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
Chao Li, MD contact
About this study
Official title: A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Read the detailed description
Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Pyrotinib Plus And, Trastuzumab, Abraxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib Plus AndDrug
Pyrotinib::400mg/d,qd,po
TrastuzumabDrug
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
AbraxaneDrug
Abraxane 125mg/M2, qw iv
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib Plus Trastuzumab And Abraxane | Experimental | Pyrotinib Plus Trastuzumab And Abraxane Receives: Drug: Pyrotinib Plus And; Drug: Trastuzumab; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) of Intracranial Lesion
Refers to the proportion of patients whose Intracranial Lesion 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: Estimated up to 1 year
Progression Free Survival(PFS) of Intracranial Lesion
the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first
Measured: Estimated up to 1 year
Secondary outcomes (3)
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: Estimated up to 1 year
Objective Response Rate (ORR)
Refers to the proportion of patients whose lesion 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: Estimated up to 1 year
disease control rate(DCR)
Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy
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 posted20 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639271
- Sponsor's protocol ID
- ShandongCHI-16
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04639271
- Acronym / sponsor ID
- ShandongCHI-16
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 20 Nov 2020 (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 trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Detailed description
Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
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 Trastuzumab And Abraxane | Experimental | Drug: Pyrotinib Plus And, Drug: Trastuzumab, Drug: AbraxanePyrotinib Plus Trastuzumab And Abraxane |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged >18 years.
- ECOG performance status ≤2.
- Histologically or cytologic confirmed HER2 positive advanced breast cancer.
- MRI confirmed brain metastases. According to RECIST 1.1, at least one measurable lesion exists.
- No limit of previous chemotherapy lines.
Key exclusion criteria (10 listed)
- Patients with brain metastases who have extensive meningeal metastases and are treated with hormone dehydration.
- Subjects with third space fluid(such as a large amount of pleural effusion and ascites) that can not be controled by drainage or other methods. (such as pleural effusion and ascites).
- Received whole brain radiotherapy, chemotherapy, surgery or target therapy within 2 weeks prior to randomization. Received hormone therapy within 1 weeks prior to randomization, Received the nitrosoureas or mitomycin chemotherapy within 6 weeks prior to randomization.
- Participated in other clinical trial within 4 weeks prior to randomization.
- Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) (including Lapatinib, Neratinib and Pyrotinib).
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 AndPyrotinib::400mg/d,qd,po | Drug | Pyrotinib Plus Trastuzumab And Abraxane |
| Trastuzumab8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle | Drug | Pyrotinib Plus Trastuzumab And Abraxane |
| AbraxaneAbraxane 125mg/M2, qw iv | Drug | Pyrotinib Plus Trastuzumab And Abraxane |
Primary outcome
Objective Response Rate (ORR) of Intracranial Lesion
Time frame: Estimated up to 1 year
Refers to the proportion of patients whose Intracranial Lesion 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
Progression Free Survival(PFS) of Intracranial Lesion
Time frame: Estimated up to 1 year
the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first
3 secondary outcomes
Progression Free Survival(PFS)
Time frame: Estimated up to 1 year
Objective Response Rate (ORR)
Time frame: Estimated up to 1 year
disease control rate(DCR)
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 20 Nov 2020.
- 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.
Chao Li, MD contact
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 And, Trastuzumab and Abraxane in people with Breast Cancer and HER2-positive Breast Cancer, run by Shandong Cancer Hospital and Institute 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 9 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 20 Nov 2020. 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 Zhiyong Yu, PhD (86-13355312277, drzhiyongyu@aliyun.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 Intracranial Lesion (time frame: Estimated up to 1 year). 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?
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 20 Nov 2020.