Breast CancerNCT06015100
Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis
A study testing Inetetamab plus pyrotiniband and capecitabine in people with Breast Cancer, run by Yan Xue at 1 site in China.
Trial summary
This study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab. It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and safety. 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 plus pyrotiniband and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2021to 31 Aug 2023
- Phase
- Interventional
- 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
- Patients who can voluntarily sign an informed consent form;
- Females aged ≥18 years at the time of signing the informed consent form;
- ECOG PS performance status score between 0 and 2;
- Patients histologically diagnosed with HER2-positive metastatic breast cancer, with or without brain metastasis, and with locally recurrent disease that cannot undergo curative surgery or radiation therapy;
- Patients who experience relapse or metastasis within 1 year during or after (neo)adjuvant pertuzumab-based targeted therapy, or disease progression during first-line pertuzumab-based targeted therapy in advanced stages;
- Patients who have received ≤1 regimen of previous pertuzumab-based targeted therapy for recurrent or metastatic disease;
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- Brain metastasis patients must meet the following criteria: stable previous brain metastasis treatment, untreated brain metastasis with no immediate need for local treatment, or progressive previous brain metastasis without immediate need for local treatment;
- Left ventricular ejection fraction (LVEF) ≥50%;
- Blood routine examination meets the following conditions: ① absolute neutrophil count (ANC) ≥1.5×109/L, ② platelet count ≥100×109/L, ③ hemoglobin ≥90g/L, ④ white blood cell count ≥3.0×109/L;
- Liver function meets the following conditions: ① serum total bilirubin ≤1.5×ULN, or ≤3×ULN if liver metastasis is present, ② aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if liver metastasis is present;
- Renal function meets the following conditions: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (creatinine clearance calculated according to the Cockcroft-Gault formula);
- Female patients who meet the following conditions can participate in this study: ① not fertile; ② fertility potential, with a negative pregnancy test result within 7 days before the first administration of the study drug, not breastfeeding, and consistently using highly effective contraceptive measures before study enrollment, throughout the study period, and within 6 months after the last administration of the study drug.
Who cannot join
- Those who have previously received Inetetamab and/or pyrotinib treatment;
- Those who have received capecitabine treatment within the past 2 weeks before randomization;
- Patients with noticeable symptoms who require immediate local treatment for brain metastasis;
- Exclusion criteria include having had or currently having any other malignant tumors within the past 5 years, except for cured cervical intraepithelial neoplasia, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor invasion of the basement membrane)];
- Exclusion criteria include having undergone major surgical procedures (including thoracotomy biopsy) within the past 4 weeks before randomization, suffering from major trauma (such as bone fracture), having unhealed wounds or fractures at the time of screening, or anticipating the need for major surgery during the study treatment period;
- Exclusion criteria include having a history of myocardial infarction within the past 6 months; New York Heart Association (NYHA) class ≥ II congestive heart failure history, severe arrhythmia uncontrolled by medication (excluding atrial fibrillation, paroxysmal supraventricular tachycardia); known decrease in left ventricular ejection fraction (LVEF) to below 50% during or after previous trastuzumab treatment;
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- Known allergy to the drugs and excipients involved in this trial;
- Known history of hypersensitivity reactions to any investigational drug;
- Subjects deemed unfit for participation by other researchers.
Trial locations and contacts
1 site in 1 country.
About this study
This study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab. It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to cross-resistance; ② its oral formulation is convenient for administration, making it more acceptable to patients; ③ previous studies have shown good efficacy when combined with pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence can be provided for the dual-target treatment of original Chinese drugs, as well as the treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for patients with brain metastasis.
Read the detailed description
Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis).
Study Drugs - Injectable pertuzumab: 50mg/vial - Pyrotinib: 80mg/tablet
Research Objective To evaluate the effectiveness and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis). This study aims to provide preliminary evidence for the dual-target treatment of original Chinese drugs, and to add new data to the treatment model for trastuzumab-resistant HER2+ MBC and patients with brain metastasis.
Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 40 patients.
- Conditions
- Breast Cancer
- Being tested
- Inetetamab plus pyrotiniband and capecitabine
- 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 plus pyrotiniband and capecitabineDrug
Inetetamab plus pyrotiniband and capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Label 1 | Experimental | Inetetamab plus pyrotiniband and capecitabine Receives: Drug: Inetetamab plus pyrotiniband and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
It is an indicator of the long-term efficacy of the drug
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Objective Response Rate
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 4 weeks
Disease Control Rate
The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).
Measured: 4 weeks
Overall survival
It is an indicator of the long-term efficacy of the drug
Measured: the time from randomization to death from any cause, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start20 Feb 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Xue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Xue, Xi'an International Medical Center Hospital
- Investigators
- Yan Xue, Principal investigator, Xi'an International Medical Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015100
- Sponsor's protocol ID
- CORP-239-Ｎ3
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 29 Aug 2023
- 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 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis
- ClinicalTrials.gov ID
- NCT06015100
- Acronym / sponsor ID
- CORP-239-Ｎ3
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yan XueUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 29 Aug 2023 (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 study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab. It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to cross-resistance; ② its oral formulation is convenient for administration, making it more acceptable to patients; ③ previous studies have shown good efficacy when combined with pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence can be provided for the dual-target treatment of original Chinese drugs, as well as the treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for patients with brain metastasis.
Detailed description
Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis).
Study Drugs - Injectable pertuzumab: 50mg/vial - Pyrotinib: 80mg/tablet
Research Objective To evaluate the effectiveness and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis). This study aims to provide preliminary evidence for the dual-target treatment of original Chinese drugs, and to add new data to the treatment model for trastuzumab-resistant HER2+ MBC and patients with brain metastasis.
Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Label 1 | Experimental | Drug: Inetetamab plus pyrotiniband and capecitabineInetetamab plus pyrotiniband and capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who can voluntarily sign an informed consent form;
- Females aged ≥18 years at the time of signing the informed consent form;
- ECOG PS performance status score between 0 and 2;
- Patients histologically diagnosed with HER2-positive metastatic breast cancer, with or without brain metastasis, and with locally recurrent disease that cannot undergo curative surgery or radiation therapy;
- Patients who experience relapse or metastasis within 1 year during or after (neo)adjuvant pertuzumab-based targeted therapy, or disease progression during first-line pertuzumab-based targeted therapy in advanced stages;
Key exclusion criteria (9 listed)
- Those who have previously received Inetetamab and/or pyrotinib treatment;
- Those who have received capecitabine treatment within the past 2 weeks before randomization;
- Patients with noticeable symptoms who require immediate local treatment for brain metastasis;
- Exclusion criteria include having had or currently having any other malignant tumors within the past 5 years, except for cured cervical intraepithelial neoplasia, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor invasion of the basement membrane)];
- Exclusion criteria include having undergone major surgical procedures (including thoracotomy biopsy) within the past 4 weeks before randomization, suffering from major trauma (such as bone fracture), having unhealed wounds or fractures at the time of screening, or anticipating the need for major surgery during the study treatment period;
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 plus pyrotiniband and capecitabineInetetamab plus pyrotiniband and capecitabine | Drug | Label 1 |
Primary outcome
Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
It is an indicator of the long-term efficacy of the drug
3 secondary outcomes
Objective Response Rate
Time frame: 4 weeks
Disease Control Rate
Time frame: 4 weeks
Overall survival
Time frame: the time from randomization to death from any cause, assessed up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- 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.
Yan Xue principal investigator
Xi'an International Medical Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inetetamab plus pyrotiniband and capecitabine in people with Breast Cancer, run by Yan Xue 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 12 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. 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.
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?
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?
Progression-Free Survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 29 Aug 2023.