Breast CancerNCT05980208
A Real-world Study of Inetetamab for First-line Treatment of MBC
An observational study of Breast Cancer and Real-world Study, run by Hunan Cancer Hospital.
Trial summary
This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Real-world Study
- What is being tested?
- Inetetamab
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Dec 2026
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: First-line treatment of HER2 positive inoperable local advanced or recurrent metastatic breast cancer patients.
Who may be able to join
- Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;
- Her2-positive invasive breast cancer confirmed by pathological examination met the following conditions:
- Positive HER2 expression: Immunohistochemical staining (IHC) showed positive HER2 3+ and/or fluorescence in situ hybridization (FISH); Tumor staging: inoperable locally advanced or recurrent metastatic breast cancer; Patients with local recurrence must be confirmed by the investigator to be unable to undergo radical surgical excision.
- At least one measurable lesion was present according to RECIST1.1 criteria;
- The ECOG score is 0 to 1;
- No systematic antitumor therapy (except first-line endocrine therapy) has been received at the locally advanced stage (clinically inoperable) or at the stage of recurrence and metastasis;
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- The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocyte enhancing and platelet enhancing drugs) :
- Blood routine: neutrophils (ANC) ≥1.5×109/L; Platelet count (PLT) ≥90×109/L; Hemoglobin (Hb) ≥90 g/L;
- Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal value (ULN), known patients with Gilbert syndrome, TBIL≤2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN, patients with liver metastasis required ALT and AST≤5×ULN; Alkaline phosphatase ≤2.5×ULN; Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
- Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥50%;
- 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) <470 msec;
- Expected survival ≥3 months;
- Participate in this study voluntarily, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Who cannot join
- Known allergic history of drug components of the program;
- Patients judged unsuitable for systematic chemotherapy by researchers;
- Use of endocrine therapy drugs within 14 days before baseline;
- Patients with only bone or skin as target lesions;
- Other malignancies, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, within the previous 5 years;
- Peripheral neuropathy ≥ grade 3 according to CTCAE 5.0 criteria;
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- Had received major surgical procedures or significant trauma within 4 weeks prior to randomization, or was expected to receive major surgical treatment;
- Serious heart disease or discomfort, including but not limited to:
- heart failure or contraction dysfunction (LVEF <50%) past medical history high risk or the need for treatment of angina or arrhythmia (such as second degree atrioventricular block type 2 or 3 degree atrioventricular block, ventricular tachycardia) clinical significance of heart valve disease ECG showed wall permeability myocardial infarction poorly controlled hypertension, systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg
- Dysphagia, chronic diarrhea, intestinal obstruction and other factors affecting drug delivery and absorption;
- A history of immunodeficiency, including HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Participated in other drug clinical studies within 4 weeks prior to screening;
- There is a third interstitial effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods;
- Pregnant or lactating women, women of childbearing age who are unable to take effective contraceptive measures throughout the trial period;
- Have a serious concomitant disease or other co-medical condition that interferes with planned treatment or any other condition that is not suitable for participation in the study, such as active hepatitis B, lung infection requiring treatment, etc.
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
Official title: A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer
This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.
- Conditions
- Breast Cancer, Real-world Study
- Being tested
- Inetetamab
- Keywords
- breast cancer, real-world study, HER2-postive, inetetamab
- 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
Inetetamab-based treatment for first-line treatment of HER2-positive MBC
| Study group | Role | What they receive |
|---|---|---|
| Inetetamab | Inetetamab-based treatment for first-line treatment of HER2-positive MBC Receives: Drug: Inetetamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months
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 60 months
Secondary outcomes (3)
Objective Response Rate
The total rate of CR+PR after the completion of two cycles of treatment.
Measured: From date of randomization until the date at the end of the second treatment cycle (42 days)
Overall survival
The time from randomization to death from any cause
Measured: The time from randomization to death from any cause, whichever came first, assessed up to 60 months
Adverse Events
All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
Measured: The time from randomization to reach the endpoint, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Medical University General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980208
- Sponsor's protocol ID
- KY-2023071101
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05980208
- Acronym / sponsor ID
- KY-2023071101
- Conditions
- Breast Cancer, Real-world Study
- Keywords
- breast cancer, real-world study, HER2-postive, inetetamab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Collaborators
- Hunan Medical University General Hospital
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 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 is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inetetamab | – | Drug: InetetamabInetetamab-based treatment for first-line treatment of HER2-positive MBC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- First-line treatment of HER2 positive inoperable local advanced or recurrent metastatic breast cancer patients.
Key inclusion criteria (13 listed)
- Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;
- Her2-positive invasive breast cancer confirmed by pathological examination met the following conditions:
- Positive HER2 expression: Immunohistochemical staining (IHC) showed positive HER2 3+ and/or fluorescence in situ hybridization (FISH); Tumor staging: inoperable locally advanced or recurrent metastatic breast cancer; Patients with local recurrence must be confirmed by the investigator to be unable to undergo radical surgical excision.
- At least one measurable lesion was present according to RECIST1.1 criteria;
- The ECOG score is 0 to 1;
Key exclusion criteria (15 listed)
- Known allergic history of drug components of the program;
- Patients judged unsuitable for systematic chemotherapy by researchers;
- Use of endocrine therapy drugs within 14 days before baseline;
- Patients with only bone or skin as target lesions;
- Other malignancies, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, within the previous 5 years;
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 |
|---|---|---|
| InetetamabInetetamab-based treatment for first-line treatment of HER2-positive MBC | Drug | Inetetamab |
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 60 months
The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months
3 secondary outcomes
Objective Response Rate
Time frame: From date of randomization until the date at the end of the second treatment cycle (42 days)
Overall survival
Time frame: The time from randomization to death from any cause, whichever came first, assessed up to 60 months
Adverse Events
Time frame: The time from randomization to reach the endpoint, assessed up to 60 months
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 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Breast Cancer and Real-world Study, run by Hunan Cancer Hospital.
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 13 inclusion and 15 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 8 Aug 2023. 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.
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 Quchang Ouyang, Prof. Dr. (+86 13973135318, ouyangquchang@hnca.org.cn), or a site near the patient. 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 60 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 8 Aug 2023.