Breast CancerPhase 2NCT05444998
Neoadjuvant Inetetamab and Pyrotinib and Nab-paclitaxel for HER2+Breast Cancer
A Phase 2 study testing Inetetamab, pyrotinib, nab-paclitaxel in people with Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced 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
- What is being tested?
- Inetetamab, pyrotinib, nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 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
- female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0 ~ 1;
- HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- known hormone receptor status (ER and PgR);
- The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening):
- 1) Blood routine neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemical total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) echocardiography score (LVEF) ≥ 55%; 4) 12 ECG Fridericia-corrected QT interval (QTcF) < 470 msec; 6. For premenopausal or non-surgically sterile female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during treatment and for at least 7 months after the last dose of the study treatment.
- 7. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
Who cannot join
- stage IV (metastatic) breast cancer;
- inflammatory breast cancer;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
- severe heart disease or discomfort
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- inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
- known to have a history of allergy to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the study;
- 10. suffering from serious concomitant diseases or other diseases that will interfere with the planned treatment of concomitant diseases, or any other conditions that the investigator believes that the patient is not suitable for this study
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fourth military medical universit
Xi'an, Shannxi, 710032
About this study
Official title: A Prospective, Open-label, Single-arm Phase II Study of Neoadjuvant Inetetamab Combined With Pyrotinib and Nab-paclitaxel in Patients With HER2-positive Early and Locally Advanced Breast Cancer
Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
Read the detailed description
This study is a prospective, open-label, single-arm clinical study, and it is planned to include 20 treatment-naive patients with HER2-positive early or locally advanced breast cancer (clinical stage IIA ~ IIIC). Neoadjuvant treatment regimen was inetetamab + pyrotinib + nab-paclitaxel. To explore the efficacy and safety of the combination of inetetamab,pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
- Conditions
- Breast Cancer
- Being tested
- Inetetamab, pyrotinib, nab-paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inetetamab, pyrotinib, nab-paclitaxelDrug
Pyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15 or 260 mg/m2，q3w，d21; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).
The patient's postoperative adjuvant therapy was 4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.
Multiple drug interruptions for adverse events were allowed throughout.
| Study group | Role | What they receive |
|---|---|---|
| Inetetamab + pyrotinib + nab-paclitaxel | Experimental | pyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15 or 260 mg/m2，q3w，d21; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).
Postoperative adjuvant therapy:4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy. Receives: Drug: Inetetamab, pyrotinib, nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
Measured: At the end of Cycle 1 (each cycle is 14 days)
Secondary outcomes (2)
Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) as assessed per RECIST v1.1 during neoadjuvant therapy.
Measured: During the period of neadjuvant treatment, an average of 4 weeks
adverse effects
Serious adverse effect occur within neoadjuvant treatment
Measured: during the period of neadjuvant treatment, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Nov 2022
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
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.
- More trials run by Xijing HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444998
- Sponsor's protocol ID
- KY20222062-X-1
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 29 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm Phase II Study of Neoadjuvant Inetetamab Combined With Pyrotinib and Nab-paclitaxel in Patients With HER2-positive Early and Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05444998
- Acronym / sponsor ID
- KY20222062-X-1
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jul 2022 (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.
Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
Detailed description
This study is a prospective, open-label, single-arm clinical study, and it is planned to include 20 treatment-naive patients with HER2-positive early or locally advanced breast cancer (clinical stage IIA ~ IIIC). Neoadjuvant treatment regimen was inetetamab + pyrotinib + nab-paclitaxel. To explore the efficacy and safety of the combination of inetetamab,pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced 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 |
|---|---|---|
| Inetetamab + pyrotinib + nab-paclitaxel | Experimental | Drug: Inetetamab, pyrotinib, nab-paclitaxelpyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15 or 260 mg/m2，q3w，d21; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle). Postoperative adjuvant therapy:4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy. |
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)
- female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0 ~ 1;
- HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- known hormone receptor status (ER and PgR);
- The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening):
Key exclusion criteria (9 listed)
- stage IV (metastatic) breast cancer;
- inflammatory breast cancer;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
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 |
|---|---|---|
| Inetetamab, pyrotinib, nab-paclitaxelPyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15 or 260 mg/m2，q3w，d21; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle). The patient's postoperative adjuvant therapy was 4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy. Multiple drug interruptions for adverse events were allowed throughout. | Drug | Inetetamab + pyrotinib + nab-paclitaxel |
Primary outcome
Pathological complete response rate (pCR)
Time frame: At the end of Cycle 1 (each cycle is 14 days)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
2 secondary outcomes
Objective response rate (ORR)
Time frame: During the period of neadjuvant treatment, an average of 4 weeks
adverse effects
Time frame: during the period of neadjuvant treatment, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inetetamab, pyrotinib, nab-paclitaxel in people with Breast Cancer, run by Xijing Hospital 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 29 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: At the end of Cycle 1 (each cycle is 14 days)). 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 Oct 2026.