HER2-positive Breast CancerNCT06718335
Pyrotinib in HER2-positive Early Breast Cancer
A study testing Pyrotinib in people with HER2-positive Breast Cancer, run by Nie Jianyun.
Trial summary
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women aged ≥18 years and ≤75 years with newly treated breast cancer;
- Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
- Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
- Eastern Cooperative Oncology Group score 0~1;
- Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
- If the major organs function normally, the following criteria are met:
- The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG <470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.
Who cannot join
- Known allergic history of the drug components of this protocol;
- Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
- Stage IV (metastatic) breast cancer patients;
- Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
- Serious heart disease or discomfort that cannot be treated;
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- Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
- Pregnant or lactating women;
- Patients with severe liver and kidney function diseases and blood system diseases;
- Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Patients with poor compliance and refusal to cooperate with treatment; Patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multi-cohort, Exploratory Clinical Study of Pyrrotinib Maleate in HER2-positive Early Breast Cancer
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.
Read the detailed description
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden scores.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin.In adjuvant therapy, pathological complete response patients receive pyrotinib time to one year, non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine time to one year，RCB≥2 were treated with Trastuzumab Emtansine combined with pertuzumab time to one year.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Experimental | Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative pathological complete response patients receive pyrotinib (400mg, qd) for one year,. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. Receives: Drug: Pyrotinib |
| T-DM1 | Experimental | Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine (3.6 mg/kg, iv) for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. Receives: Drug: Pyrotinib |
| T-DM1 and pertuzumab | Experimental | Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB≥2 were treated with Trastuzumab Emtansine (3.6 mg/kg, iv) combined with pertuzumab for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival(EFS)
Event Free Survival
Measured: 3 year
Secondary outcomes (1)
total pathological complete response(tpCR)
total pathological complete response
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nie Jianyun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nie Jianyun, Yunnan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718335
- Sponsor's protocol ID
- OBU-BC-YUNNAN-001
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-cohort, Exploratory Clinical Study of Pyrrotinib Maleate in HER2-positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06718335
- Acronym / sponsor ID
- OBU-BC-YUNNAN-001
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Nie JianyunUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 Dec 2024 (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.
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.
Detailed description
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | Experimental | Drug: PyrotinibPatients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative pathological complete response patients receive pyrotinib (400mg, qd) for one year,. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. |
| T-DM1 | Experimental | Drug: PyrotinibPatients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine (3.6 mg/kg, iv) for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. |
| T-DM1 and pertuzumab | Experimental | Drug: PyrotinibPatients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB≥2 were treated with Trastuzumab Emtansine (3.6 mg/kg, iv) combined with pertuzumab for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators. |
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)
- Women aged ≥18 years and ≤75 years with newly treated breast cancer;
- Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
- Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
- Eastern Cooperative Oncology Group score 0~1;
- Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
Key exclusion criteria (10 listed)
- Known allergic history of the drug components of this protocol;
- Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
- Stage IV (metastatic) breast cancer patients;
- Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
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 |
|---|---|---|
| PyrotinibPatients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin.In adjuvant therapy, pathological complete response patients receive pyrotinib time to one year, non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine time to one year，RCB≥2 were treated with Trastuzumab Emtansine combined with pertuzumab time to one year. | Drug | Pyrotinib, T-DM1, T-DM1 and pertuzumab |
Primary outcome
Event Free Survival(EFS)
Time frame: 3 year
Event Free Survival
1 secondary outcome
total pathological complete response(tpCR)
Time frame: 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pyrotinib in people with HER2-positive Breast Cancer, run by Nie Jianyun.
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: opening soon, as of the sponsor's last update on 11 Dec 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nie Jian Yun, Ph.D (13608815577, njyvip@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival(EFS) (time frame: 3 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 11 Dec 2024.