Breast CancerPhase 4NCT05291910
Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
A Phase 4 study testing Inetetamab, Toripalimab and Albumin-Bound Paclitaxel in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inetetamab, Toripalimab and Albumin-Bound Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2022to 31 Dec 2025
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged > 18 years.
- Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.
- Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:
- patients with metastatic breast cancer at the time of initial diagnosis, meaning there was no previous history of breast cancer in the past; or
- patients with Locally recurrent or metastatic breast cancer, neoadjuvant/adjuvant anti-HER2 therapy has been completed for ≥6 months.
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- HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.
- PD-L1-positive (cut-off ≥ 1% stained cells);
- Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria.
- ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up.
- Cardiopulmonary function is basically normal.
- Liver function is basically normal.
- Have sufficient baseline hematology parameters.
- Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used.
- No history of serious heart, kidney and other important organs and endocrine disease.
- Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures.
- The patients voluntarily signed an informed consent form.
Who cannot join
- Participated in other clinical trials within 4 weeks;
- Evidence of symptomatic central nervous system metastasis or pia mater disease.
- History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).
- History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.
- History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.
- Immunosuppressive drugs required within 2 weeks before enrollment or during this study. The following conditions are excluded: 1) intranasal, inhalation, topical or local steroid injection (e.g., intra articular injection); 2) physiological doses of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent dose); 3) short term (≤ 7 days) use of steroids to prevent or treat non-autoimmune allergic diseases.
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- History of acute or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of primary or acquired immunodeficiency (including HIV-positive).
- History of hypersensitivity to the study medication
- Pregnancy or lactation.
- History of myocardial infarction within 6 months before enrollment, congestive heart failure (New York Heart Association [NYHA] Classes ≥ II), severe arrhythmia beyond drug control, or a decrease in LVEF to < 50% with previous trastuzumab neoadjuvant or adjuvant treatment.
- History of other malignant disease within 5 years (except cured of in-situ carcinoma of the cervix, basal cell carcinoma of the skin and squamous cell carcinoma).
- Participants who were judged by the investigator to be unsuitable for this study .
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing
Binghe Xu, MD, 010-67781331, xubinghe@medail.com.cn
About this study
Official title: A Study to Assess the Efficacy and Safety of Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.
Read the detailed description
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.To explore a new concept of anti-HER2 monoclonal antibody combined with immunotherapy in the treatment of recurrent or metastatic breast cancer. The primary end point is progression free survival (PFS). The secondary end points are objective response rate (ORR), Clinical Benefit Rate (CBR) and safety assessment.
- Conditions
- Breast Cancer
- Being tested
- Inetetamab, Toripalimab, Albumin-Bound 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.
InetetamabDrug
Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks
ToripalimabDrug
240mg intravenously every 3 weeks
Albumin-Bound PaclitaxelDrug
130mg/m2, IV , D1, D8, q3w
| Study group | Role | What they receive |
|---|---|---|
| Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel | Experimental | Drug: Inetetamab Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks Drug: Toripalimab 240mg intravenously every 3 weeks Drug: Albumin-Bound Paclitaxel 130mg/m2, IV , D1, D8, q3w Receives: Drug: Inetetamab; Drug: Toripalimab; Drug: Albumin-Bound Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is defined as the time from the date of the first dose until first evidence of disease progression or death based on investigator assessment using RECIST 1.1 and irRECIST.
Measured: Assessed up to approximately 24 months
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR) based on CT/MRI, investigator assessment using RECIST 1.1 and irRECIST.
Measured: Assessed up to approximately 24 months
Clinical benefit rate (CBR)
CBR is defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per RECIST 1.1 and irRECIST, or prolonged stable disease (≥ 6 months).
Measured: Assessed up to approximately 24 months
Safety assessment (AEs and SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From the time of inform consent form signature until 30 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start12 Mar 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, MD, Principal investigator, Director of Breast Cancer Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291910
- Sponsor's protocol ID
- SPT-2021-002
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 23 Mar 2022
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy and Safety of Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05291910
- Acronym / sponsor ID
- SPT-2021-002
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Mar 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.
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.
Detailed description
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.To explore a new concept of anti-HER2 monoclonal antibody combined with immunotherapy in the treatment of recurrent or metastatic breast cancer. The primary end point is progression free survival (PFS). The secondary end points are objective response rate (ORR), Clinical Benefit Rate (CBR) and safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel | Experimental | Drug: Inetetamab, Drug: Toripalimab, Drug: Albumin-Bound PaclitaxelDrug: Inetetamab Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks Drug: Toripalimab 240mg intravenously every 3 weeks Drug: Albumin-Bound Paclitaxel 130mg/m2, IV , D1, D8, q3w |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients aged > 18 years.
- Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.
- Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:
- HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.
Key exclusion criteria (13 listed)
- Participated in other clinical trials within 4 weeks;
- Evidence of symptomatic central nervous system metastasis or pia mater disease.
- History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).
- History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.
- History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.
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 |
|---|---|---|
| InetetamabInitial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks | Drug | Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel |
| Toripalimab240mg intravenously every 3 weeks | Drug | Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel |
| Albumin-Bound Paclitaxel130mg/m2, IV , D1, D8, q3w | Drug | Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel |
Primary outcome
Progression free survival (PFS)
Time frame: Assessed up to approximately 24 months
PFS is defined as the time from the date of the first dose until first evidence of disease progression or death based on investigator assessment using RECIST 1.1 and irRECIST.
3 secondary outcomes
Objective response rate (ORR)
Time frame: Assessed up to approximately 24 months
Clinical benefit rate (CBR)
Time frame: Assessed up to approximately 24 months
Safety assessment (AEs and SAEs)
Time frame: From the time of inform consent form signature until 30 days after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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.
Binghe Xu, MD principal investigator
Director of Breast Cancer Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inetetamab, Toripalimab and Albumin-Bound Paclitaxel in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 17 inclusion and 13 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 23 Mar 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu, MD (010-67781331, xubinghe@medail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Assessed up to approximately 24 months). 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 23 Mar 2022.