Advanced Breast CancerPhase 2NCT05020964
Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
A Phase 2 study testing Trastuzumab and Pyrotinib in people with Advanced Breast Cancer, run by Chinese Academy of Medical Sciences.
Trial summary
The hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study. The purpose of this study is: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Trastuzumab and Pyrotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2021to 1 Sep 2023
- 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
- Patients with recurrent or distant metastatic breast cancer whose primary tissue was negative for HER2 amplification, and newly diagnosed patients with stage IV breast cancer who were negative for HER2 amplification; All enrolled patients had previously received ≥ second-line therapy; Note: ① negative expression of HER2 refers to the primary tissue tested by IHC/FISH (clinical report), and the cell immunohistochemical staining intensity is 0,1 + or 2+, but negative by fluorescence in situ hybridization (FISH).
- Age range 18-75, female;
- Good physical strength: ECOG score 0-1;
- Expected survival of more than 3 months;
- The patient had no major organ dysfunction;Include: Routine blood The ANC acuity 1.5 x 109 / L;PLT acuity 90 x 109 / L;Hb 90 g/L or higher; Blood biochemical 1.5 x ULN TBIL or less;ALT and AST 2 x ULN or less;ALT and AST≤5×ULN in patients with liver metastases;BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); Heart colour to exceed LVEF 50% or higher;Fridericia adjusted QT interval (QTcF) for 12-lead electrocardiogram in men < 450 ms and in women < 470 ms.
- Evaluable tumor lesions according to RECIST 1.1 criteria;
- Voluntarily join the group, agree and sign the written informed consent.
Who cannot join
- Patients who have previously received anti-HER2 therapy, or who have received a study drug or preparation/treatment (i.e., participating in another trial) within 4 weeks prior to enrollment;
- Patients who are allergic to study drugs or unable to take them orally;Patients who refuse the medication regimen;
- Serious dysfunction of vital organs (heart, liver, kidney);Clinically significant heart disease, i.e., New York Heart Association (NYHA) grade ⅲ - ⅳ heart failure or more severe congestive heart failure or severe arrhythmias requiring pharmacological intervention;Uncontrollable angina pectoris, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction within 6 months as confirmed by electrocardiogram (ECG);Previous history of organ transplantation, splenectomy;
- Patients with other malignancies, except for cured non-melanoma skin cancers, cervical carcinoma in situ and other tumors that have been cured for at least 5 years;
- Pregnant and lactating women (women of childbearing age are subject to pregnancy tests), fertile women with positive baseline pregnancy tests, or women of childbearing age who are unwilling to use effective contraception throughout the study period.;
- In the active period of other acute infectious diseases or chronic infectious diseases;
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- A history of uncontrolled epilepsy, central nervous system disease or mental disorder;
- Persons with disabilities of consciousness and other legal capacity or legal capacity limited;
- A known history of human immunodeficiency virus;
- Other conditions that the investigator considers inappropriate for the patient to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
The hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study.
The purpose of this study is:
- To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
- To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
Read the detailed description
The purpose of this study is:
- To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
- To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- Trastuzumab and Pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab and PyrotinibDrug
Trastuzumab: 3-week dosing regimen, The initial load dose was 8 mg/kg. Pyrotinib: 400 mg orally once daily, take it continuously, every 21 days as a cycle.
Use until intolerable toxicity or disease progression occurs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Trastuzumab and Pyrotinib Receives: Drug: Trastuzumab and Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate(ORR)
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Measured: up to 1 year after the last patient enrolled
Secondary outcomes (2)
Progression free survival(PFS)
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Measured: up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
hematologic, hepatotoxicity, Incidence of hypertension, Incidence of proteinuria
Measured: approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start20 Aug 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 68 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
- Yuan Peng, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020964
- Sponsor's protocol ID
- NCC1888
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
- ClinicalTrials.gov ID
- NCT05020964
- Acronym / sponsor ID
- NCC1888
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Aug 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Aug 2021 (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 hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study.
The purpose of this study is:
- To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
- To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
Detailed description
The purpose of this study is:
- To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
- To explore the potential using of digital PCR in recurrent and 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 |
|---|---|---|
| Experimental Arm | Experimental | Drug: Trastuzumab and PyrotinibTrastuzumab and Pyrotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with recurrent or distant metastatic breast cancer whose primary tissue was negative for HER2 amplification, and newly diagnosed patients with stage IV breast cancer who were negative for HER2 amplification; All enrolled patients had previously received ≥ second-line therapy; Note: ① negative expression of HER2 refers to the primary tissue tested by IHC/FISH (clinical report), and the cell immunohistochemical staining intensity is 0,1 + or 2+, but negative by fluorescence in situ hybridization (FISH).
- Age range 18-75, female;
- Good physical strength: ECOG score 0-1;
- Expected survival of more than 3 months;
- The patient had no major organ dysfunction;Include: Routine blood The ANC acuity 1.5 x 109 / L;PLT acuity 90 x 109 / L;Hb 90 g/L or higher; Blood biochemical 1.5 x ULN TBIL or less;ALT and AST 2 x ULN or less;ALT and AST≤5×ULN in patients with liver metastases;BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); Heart colour to exceed LVEF 50% or higher;Fridericia adjusted QT interval (QTcF) for 12-lead electrocardiogram in men < 450 ms and in women < 470 ms.
Key exclusion criteria (10 listed)
- Patients who have previously received anti-HER2 therapy, or who have received a study drug or preparation/treatment (i.e., participating in another trial) within 4 weeks prior to enrollment;
- Patients who are allergic to study drugs or unable to take them orally;Patients who refuse the medication regimen;
- Serious dysfunction of vital organs (heart, liver, kidney);Clinically significant heart disease, i.e., New York Heart Association (NYHA) grade ⅲ - ⅳ heart failure or more severe congestive heart failure or severe arrhythmias requiring pharmacological intervention;Uncontrollable angina pectoris, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction within 6 months as confirmed by electrocardiogram (ECG);Previous history of organ transplantation, splenectomy;
- Patients with other malignancies, except for cured non-melanoma skin cancers, cervical carcinoma in situ and other tumors that have been cured for at least 5 years;
- Pregnant and lactating women (women of childbearing age are subject to pregnancy tests), fertile women with positive baseline pregnancy tests, or women of childbearing age who are unwilling to use effective contraception throughout the study period.;
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 |
|---|---|---|
| Trastuzumab and PyrotinibTrastuzumab: 3-week dosing regimen, The initial load dose was 8 mg/kg. Pyrotinib: 400 mg orally once daily, take it continuously, every 21 days as a cycle. Use until intolerable toxicity or disease progression occurs. | Drug | Experimental Arm |
Primary outcome
objective response rate(ORR)
Time frame: up to 1 year after the last patient enrolled
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
2 secondary outcomes
Progression free survival(PFS)
Time frame: up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
Time frame: approximately 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
Yuan Peng study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab and Pyrotinib in people with Advanced Breast Cancer, run by Chinese Academy of Medical Sciences.
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 7 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Yuan Peng (01087787245, 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) (time frame: up to 1 year after the last patient enrolled). 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 25 Aug 2021.