HER2-positive Recurrent/Metastatic Breast CancerPhase 2NCT05621434
A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer
A Phase 2 study testing Inetetamab, pyrotinib, chemotherapy in people with HER2-positive Recurrent/Metastatic Breast Cancer, run by Fujian Medical University.
Trial summary
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and PUFFIN studies confirmed that trastuzumab combined with pertuzumab achieved PFS of 18.7… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Recurrent/Metastatic Breast Cancer
- What is being tested?
- Inetetamab, pyrotinib, chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2022to 10 Dec 2025
- 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
- Aged 18 ~ 75 years old, female;
- Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion exists;
- ECOG PS score 0-1 points;
- No systemic antitumor therapy (except first line endocrine therapy) in relapse/metastasis;
- If prior anti-HER2 therapy (including trastuzumab, trastuzumab biosimilar, Inetetamab, pertuzumab, tyrosine kinase inhibitors such as pyrotinib, T-DM1) was used in the (neo) adjuvant phase, the interval between the end of anti-HER2 therapy to the diagnosis of relapse/metastasis was ≥ 12 months;
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- Adequate organ function;
- Expected survival ≥ 3 months;
- Patients voluntarily sign informed consent, have good compliance and are willing to cooperate in follow-up.
Who cannot join
- Known to have a history of hypersensitivity to the drug components of this protocol;
- Investigators judged that they were not suitable for systemic chemotherapy;
- Endocrine therapy drugs were used within 14 days before baseline;
- Active brain metastases;
- Only bone or skin as target lesions;
- Patients with other malignant tumors within 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma;
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- Grade≥3 peripheral neuropathy according to CTCAE 5.0 criteria;
- Patients who have previously received more than the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicin > 360 mg/m2, epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, others (such as other anthracyclines or multiple anthracyclines, cumulative dose > 360 mg/m2 of doxorubicin);
- Received major surgical procedures or significant trauma within 4 weeks before randomization, or patients are expected to receive major surgical treatment;
- Serious heart problems or discomfort;
- Dysphagia, chronic diarrhea, intestinal obstruction and other factors affecting administration and absorption;
- History of immunodeficiency, including HIV infection, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation; 13. Participated in other drug clinical studies within 4 weeks before screening;
- 14. Presence of third space effusion (such as pleural effusion and ascites) that cannot be controlled by drainage or other methods; 15. Pregnant or lactating female patients, women of childbearing age who cannot take effective contraceptive measures throughout the trial; 16. With severe concomitant diseases or interfere with the planned treatment or any other condition that is not suitable for participating in this study, such as active hepatitis B, lung infection requiring treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Inetetamab, Pyrotinib and Chemotherapy in Combination for First-line Treatment of HER2-positive Recurrent/Metastatic Breast Cancer
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and PUFFIN studies confirmed that trastuzumab combined with pertuzumab achieved PFS of 18.7 and 16.5 months, respectively, and became today 's first-line standard regimen for advanced HER2 + breast cancer. Pyrotinib acts on the intracellular segment of HER2 receptor and can inhibit tumor cell growth by covalently binding to the ATP binding site in the intracellular tyrosine kinase region and blocking the activation of downstream signaling pathways. The mechanism of action of the macromolecular drug trastuzumab combined with the small molecular drug pyrotinib dual-target in the treatment of HER2-positive breast cancer is complementary and has a synergistic anti-tumor effect. In 2022, the ESMO conference reported the results of a phase III trial of pyrotinib combined with trastuzumab combined with docetaxel in advanced HER2-positive breast cancer with an LBA, with the primary endpoint of investigator-assessed PFS.The results showed a significant 59% reduction in the risk of disease progression or death compared with 10.4 months in the trastuzumab plus docetaxel arm and 24.3 months in the pyrotinib arm.
Inetetamab is a monoclonal antibody against the IV domain of the HER2 receptor with the same Fab segment as trastuzumab and different amino acid sequences from trastuzumab at positions 359 and 361 of the Fc segment heavy chain constant region, Antibody-dependent cell-mediated cytotoxicity (ADCC) was 1.11-fold higher than trastuzumab. PFS reached 11.1 months in the first-line subgroup analysis of the Phase III registration study of Inetetamab (HOPES study), which was similar to historical data from trastuzumab first-line treatment of HER2-positive metastatic breast cancer, with comparable safety. The results of this study contribute to further understanding the efficacy and safety of first-line treatment with Inetetamab Combined with Pyrotinib and Chemotherapy in HER2-positive recurrent/metastatic breast cancer patients.
Read the detailed description
This Prospective, multicenter study will include 63 patients with first-line patients with HER2-positive recurrent/metastatic breast cancer. After providing written informed consent, patients receiving Inetetamab in combination with pyrotinib and investigator 's choice chemotherapy. The effectiveness of the combined treatment will be evaluated by MRI every two treatment cycles. If the disease progresses, the participant will withdraw from the trial.
- Being tested
- Inetetamab, pyrotinib, chemotherapy
- 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, chemotherapyDrug
Also called Inetetamab for injection, Pyrotinib maleate
Inetetamab: was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
pyrotinib: 400 mg once daily orally within 30 minutes after a meal at the same time each day.
chemotherapy:Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer are permitted. Refer to the appropriate package insert for dosage and administration recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Inetetamab, pyrotinib, chemotherapy | Experimental | Inetetamab: was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
pyrotinib: 400 mg once daily orally within 30 minutes after a meal at the same time each day.
chemotherapy:Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer are permitted. Refer to the appropriate package insert for dosage and administration recommendations. Receives: Drug: Inetetamab, pyrotinib, chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from first dose to first documented radiographical progressive disease (PD) using RECIST version 1.1, or death from any cause , whichever occurred first.
Measured: Tumor assessments every 6 weeks from randomization to radiographical PD or death from any cause, whichever occurred first，up to the primary completion date (up to 2 years)
Secondary outcomes (3)
Overall response rate (ORR)
An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart
Measured: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease（SD）>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart.
Measured: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Number of Adverse Events using NCI CTCAE 5.0 [Safety and Tolerability]
Number of Adverse Events using NCI CTCAE 5.0
Measured: From signing the informed consent to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start10 Dec 2022 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Recurrent/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm study
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Wu, Fujian Medical University
- Investigators
- Jian Liu, PHD, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621434
- Sponsor's protocol ID
- K2022-025-01
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Findings from this study will indicate whether Inetetamab Combined with Pyrotinib and Chemotherapy treatment of HER2-Positive Recurrent/Metastatic Breast Cancer is safe and effective
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inetetamab, Pyrotinib and Chemotherapy in Combination for First-line Treatment of HER2-positive Recurrent/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05621434
- Acronym / sponsor ID
- K2022-025-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 18 Nov 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.
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and PUFFIN studies confirmed that trastuzumab combined with pertuzumab achieved PFS of 18.7 and 16.5 months, respectively, and became today 's first-line standard regimen for advanced HER2 + breast cancer. Pyrotinib acts on the intracellular segment of HER2 receptor and can inhibit tumor cell growth by covalently binding to the ATP binding site in the intracellular tyrosine kinase region and blocking the activation of downstream signaling pathways. The mechanism of action of the macromolecular drug trastuzumab combined with the small molecular drug pyrotinib dual-target in the treatment of HER2-positive breast cancer is complementary and has a synergistic anti-tumor effect. In 2022, the ESMO conference reported the results of a phase III trial of pyrotinib combined with trastuzumab combined with docetaxel in advanced HER2-positive breast cancer with an LBA, with the primary endpoint of investigator-assessed PFS.The results showed a significant 59% reduction in the risk of disease progression or death compared with 10.4 months in the trastuzumab plus docetaxel arm and 24.3 months in the pyrotinib arm.
Inetetamab is a monoclonal antibody against the IV domain of the HER2 receptor with the same Fab segment as trastuzumab and different amino acid sequences from trastuzumab at positions 359 and 361 of the Fc segment heavy chain constant region, Antibody-dependent cell-mediated cytotoxicity (ADCC) was 1.11-fold higher than trastuzumab. PFS reached 11.1 months in the first-line subgroup analysis of the Phase III registration study of Inetetamab (HOPES study), which was similar to historical data from trastuzumab first-line treatment of HER2-positive metastatic breast cancer, with comparable safety. The results of this study contribute to further understanding the efficacy and safety of first-line treatment with Inetetamab Combined with Pyrotinib and Chemotherapy in HER2-positive recurrent/metastatic breast cancer patients.
Detailed description
This Prospective, multicenter study will include 63 patients with first-line patients with HER2-positive recurrent/metastatic breast cancer. After providing written informed consent, patients receiving Inetetamab in combination with pyrotinib and investigator 's choice chemotherapy. The effectiveness of the combined treatment will be evaluated by MRI every two treatment cycles. If the disease progresses, the participant will withdraw from the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm study
| Arm | Type | Receives |
|---|---|---|
| Inetetamab, pyrotinib, chemotherapy | Experimental | Drug: Inetetamab, pyrotinib, chemotherapyInetetamab: was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. pyrotinib: 400 mg once daily orally within 30 minutes after a meal at the same time each day. chemotherapy:Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer are permitted. Refer to the appropriate package insert for dosage and administration recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 ~ 75 years old, female;
- Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion exists;
- ECOG PS score 0-1 points;
- No systemic antitumor therapy (except first line endocrine therapy) in relapse/metastasis;
Key exclusion criteria (13 listed)
- Known to have a history of hypersensitivity to the drug components of this protocol;
- Investigators judged that they were not suitable for systemic chemotherapy;
- Endocrine therapy drugs were used within 14 days before baseline;
- Active brain metastases;
- Only bone or skin as target lesions;
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, chemotherapyAlso: Inetetamab for injection, Pyrotinib maleateInetetamab: was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. pyrotinib: 400 mg once daily orally within 30 minutes after a meal at the same time each day. chemotherapy:Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer are permitted. Refer to the appropriate package insert for dosage and administration recommendations. | Drug | Inetetamab, pyrotinib, chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Tumor assessments every 6 weeks from randomization to radiographical PD or death from any cause, whichever occurred first，up to the primary completion date (up to 2 years)
PFS was defined as the time from first dose to first documented radiographical progressive disease (PD) using RECIST version 1.1, or death from any cause , whichever occurred first.
3 secondary outcomes
Overall response rate (ORR)
Time frame: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Clinical Benefit Rate (CBR)
Time frame: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Number of Adverse Events using NCI CTCAE 5.0 [Safety and Tolerability]
Time frame: From signing the informed consent to 30 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: Yes. Findings from this study will indicate whether Inetetamab Combined with Pyrotinib and Chemotherapy treatment of HER2-Positive Recurrent/Metastatic Breast Cancer is safe and effective
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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.
Jian Liu, PHD principal investigator
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inetetamab, pyrotinib, chemotherapy in people with HER2-positive Recurrent/Metastatic Breast Cancer, run by Fujian Medical 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 9 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 18 Nov 2022. 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 Fan Wu, MD (+8613859082118, alienglass@fjmu.edu.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: Tumor assessments every 6 weeks from randomization to radiographical PD or death from any cause, whichever occurred first，up to the primary completion date (up to 2 years)). 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 18 Nov 2022.