HER2 Positive Breast CancerPhase 4NCT06868017
Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles
A Phase 4 study testing Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses and Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses in people with HER2 Positive Breast Cancer, run by The First Hospital of Jilin University.
Trial summary
The purpose of this study was to explore the efficacy and safety of initumab combined with pyrrotinib and chemotherapy for 4 cycles and 6 cycles of neoadjuvant therapy for HER2-positive breast cancer, and to explore the efficacy and safety of continued use of initumab combined with pyrrotinib in pCR patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HER2 Positive Breast Cancer
- What is being tested?
- Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses and Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 19 Feb 2027
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old, while ≤70 years old, gender is not limited; 2.2. Invasive breast cancer confirmed histologically by air-core needle biopsy; According to AJCC breast cancer Staging System 8th edition, clinical staging was T1c-4, N0-3, M0.
- 3. HER2 positive: IHC 3+ or IHC 2+ and FISH+ 4.Left ventricular ejection fraction (LVEF) ≥ 50% 5.ECOG physical condition score is 0 or 1 6.In the absence of blood transfusion or symptomatic treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to initial administration, organ function must meet the following requirements Blood routine: absolute value of neutrophil (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90g/L Blood biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT and AST≤1.5×ULN; BUN and Cr≤1.5×ULN; Creatinine clearance ≥50mL/min (Cockcroft-Gault formula) 7.Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Who cannot join
- Previous history of invasive breast cancer
- Bilateral breast cancer, inflammatory breast cancer (e.g., erythema and/or skin involvement, and/or pathological findings of tumor cells in the dermal lymphatic vessels), or clinical stage T1c, N0, M0
- Prior biopsy of primary tumor and/or axillary lymph node excision and/or excision
- Previous systemic treatment for breast cancer;
- A history of life-threatening hypersensitivity, or a known history of allergy to any component of the investigational drug;
- Participated in clinical trials of other drugs or medical devices within 4 weeks before the first drug use, and received treatment with experimental drugs or devices
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- Patients who had undergone major surgery within 28 days prior to the first dose or planned to undergo major surgery during the study period
- Other malignant tumors (excluding cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ) within the previous 5 years
- Active hepatitis, active tuberculosis or other serious infectious diseases, including but not limited to: Active hepatitis C virus (HCV) infection (HCV antibody positive but not RNA negative), or hepatitis B virus (HBV) infection (HBV surface antigen positive and HBV-DNA copy number >2000 IU/mL) or other serious infections requiring systemic treatment such as bacteremia, severe infectious pneumonia
- A history of immunodeficiency or other autoimmune diseases, including but not limited to human immunodeficiency virus (HIV) infection (HIV-positive), systemic lupus erythematosus, rheumatoid arthritis, or a history of organ transplantation
- Patients with a history of cardiovascular and cerebrovascular diseases, including: (1) unstable angina pectoris; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction occurring within 6 months; (4) Heart failure, degree II and above atrioventricular block; (5) Cerebral infarction (except lacunar cerebral infarction), cerebral hemorrhage and other diseases occurring within 6 months
- Patients with poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg under regular medication), or with a prior history of hypertensive crisis or hypertensive encephalopathy
- Pregnant and lactating female patients; Pregnant women of childbearing age who were positive in screening pregnancy test; Patients who are unwilling to use effective contraception throughout the trial period and for 6 months after the end of medication
- Other circumstances deemed inappropriate by the investigator to participate in 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
The purpose of this study was to explore the efficacy and safety of initumab combined with pyrrotinib and chemotherapy for 4 cycles and 6 cycles of neoadjuvant therapy for HER2-positive breast cancer, and to explore the efficacy and safety of continued use of initumab combined with pyrrotinib in pCR patients.
This study adopted A prospective, randomized controlled, open-label design, and selected eligible subjects to be randomly divided into cohort A and Cohort B. Cohort A will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 4 cycles of administration. After surgery for breast cancer, initumab + pyrrotinib was selected as adjuvant therapy for pCR patients after surgery for 1 year (neoadjuvant therapy + adjuvant therapy for a total of 1 year, a total of 13 cycles of adjuvant therapy), and non-pCR patients were selected by doctors. Cohort B will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 6 cycles of administration. After surgery for breast cancer, initumab + pyrrotinib was selected as adjuvant therapy for pCR patients after surgery for 1 year (neoadjuvant therapy + adjuvant therapy for a total of 1 year, and adjuvant therapy for a total of 11 cycles), and non-pCR patients were selected by doctors.
- Conditions
- HER2 Positive Breast Cancer
- Being tested
- Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses, Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 dosesDrug
Cohort A will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 4 cycles of administration
Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 dosesDrug
The initial loading dose of initumab was 8mg/kg, and the maintenance dose was 6mg/kg, which was administered intravenously on the first day of every three weeks. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 6 cycles of administration
| Study group | Role | What they receive |
|---|---|---|
| Queue A | Other | Not described Receives: Drug: Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses |
| Queue B | Other | Not described Receives: Drug: Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
total Pathological Complete Response，tpCR
Measured: After completion of neoadjuvant therapy, subjects' completely removed breast specimens and all sampled regional lymph nodes were evaluated
Secondary outcomes (4)
Overall Response Rate，ORR
Measured: It refers to the percentage of cases that achieved complete response (CR) and partial response (PR) after neoadjuvant therapy as a percentage of the total number of evaluable cases
Event-Free Survival，EFS
Measured: Refers to the time from enrollment to the first recorded recurrence of disease, disease progression, or death from any cause after surgery
Invasive Disease-Free Survival，iDFS
Measured: Refers to the time from enrollment to the first occurrence of an aggressive ipsilateral tumor recurrence, aggressive countermeasure breast cancer, local/regional aggressive recurrence, distant recurrence, or death from any cause
Overall Survival
Measured: Refers to the time from enrollment to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion19 Feb 2026 (estimated)
- Study completion19 Feb 2027 (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.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868017
- Sponsor's protocol ID
- OBU-BC-II-206
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles
- ClinicalTrials.gov ID
- NCT06868017
- Acronym / sponsor ID
- OBU-BC-II-206
- Conditions
- HER2 Positive Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 19 Feb 2026 (estimated)
- Study completion
- 19 Feb 2027 (estimated)
- First posted
- 10 Mar 2025 (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 was to explore the efficacy and safety of initumab combined with pyrrotinib and chemotherapy for 4 cycles and 6 cycles of neoadjuvant therapy for HER2-positive breast cancer, and to explore the efficacy and safety of continued use of initumab combined with pyrrotinib in pCR patients.
This study adopted A prospective, randomized controlled, open-label design, and selected eligible subjects to be randomly divided into cohort A and Cohort B. Cohort A will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 4 cycles of administration. After surgery for breast cancer, initumab + pyrrotinib was selected as adjuvant therapy for pCR patients after surgery for 1 year (neoadjuvant therapy + adjuvant therapy for a total of 1 year, a total of 13 cycles of adjuvant therapy), and non-pCR patients were selected by doctors. Cohort B will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 6 cycles of administration. After surgery for breast cancer, initumab + pyrrotinib was selected as adjuvant therapy for pCR patients after surgery for 1 year (neoadjuvant therapy + adjuvant therapy for a total of 1 year, and adjuvant therapy for a total of 11 cycles), and non-pCR patients were selected by doctors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Queue A | Other | Drug: Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses |
| Queue B | Other | Drug: Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age ≥18 years old, while ≤70 years old, gender is not limited; 2.2. Invasive breast cancer confirmed histologically by air-core needle biopsy; According to AJCC breast cancer Staging System 8th edition, clinical staging was T1c-4, N0-3, M0.
- 3. HER2 positive: IHC 3+ or IHC 2+ and FISH+ 4.Left ventricular ejection fraction (LVEF) ≥ 50% 5.ECOG physical condition score is 0 or 1 6.In the absence of blood transfusion or symptomatic treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to initial administration, organ function must meet the following requirements Blood routine: absolute value of neutrophil (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90g/L Blood biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT and AST≤1.5×ULN; BUN and Cr≤1.5×ULN; Creatinine clearance ≥50mL/min (Cockcroft-Gault formula) 7.Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Key exclusion criteria (14 listed)
- Previous history of invasive breast cancer
- Bilateral breast cancer, inflammatory breast cancer (e.g., erythema and/or skin involvement, and/or pathological findings of tumor cells in the dermal lymphatic vessels), or clinical stage T1c, N0, M0
- Prior biopsy of primary tumor and/or axillary lymph node excision and/or excision
- Previous systemic treatment for breast cancer;
- A history of life-threatening hypersensitivity, or a known history of allergy to any component of the investigational 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 |
|---|---|---|
| Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 dosesCohort A will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 4 cycles of administration | Drug | Queue A |
| Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 dosesThe initial loading dose of initumab was 8mg/kg, and the maintenance dose was 6mg/kg, which was administered intravenously on the first day of every three weeks. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 6 cycles of administration | Drug | Queue B |
Primary outcome
total Pathological Complete Response，tpCR
Time frame: After completion of neoadjuvant therapy, subjects' completely removed breast specimens and all sampled regional lymph nodes were evaluated
4 secondary outcomes
Overall Response Rate，ORR
Time frame: It refers to the percentage of cases that achieved complete response (CR) and partial response (PR) after neoadjuvant therapy as a percentage of the total number of evaluable cases
Event-Free Survival，EFS
Time frame: Refers to the time from enrollment to the first recorded recurrence of disease, disease progression, or death from any cause after surgery
Invasive Disease-Free Survival，iDFS
Time frame: Refers to the time from enrollment to the first occurrence of an aggressive ipsilateral tumor recurrence, aggressive countermeasure breast cancer, local/regional aggressive recurrence, distant recurrence, or death from any cause
Overall Survival
Time frame: Refers to the time from enrollment to death
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 10 Mar 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses and Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses in people with HER2 Positive Breast Cancer, run by The First Hospital of Jilin University.
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 2 inclusion and 14 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 10 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 dongsong S dongsong (+8613943189777, songdong117@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total Pathological Complete Response，tpCR (time frame: After completion of neoadjuvant therapy, subjects' completely removed breast specimens and all sampled regional lymph nodes were evaluated). 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 10 Mar 2025.