Breast CancerNCT06340165
A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer
An observational study of Breast Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anlotinib
- Type of treatment
- Pill or oral medicine
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2024to Jun 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective cohort study to collect clinical data of patients with HER-2 negative advanced breast cancer treated with amrutinib at four centers four centers at the First Hospital of Jilin University, Liaoning Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, and Peking University Cancer Hospital between 2019.1 and 2022.9
Who may be able to join
- Imaging or tissue/cell puncture, etc. confirmed recurrent, metastatic breast cancer
- Pathologically confirmed HER-2 negative
- Application of amlotinib treatment until disease progression or toxicity intolerable, or voluntarily give up the continuation of amlotinib treatment,amlotinib application for at least 2 cycles
- The clinical data are basically complete
Who cannot join
- Patients receiving local treatment means such as surgery and radiotherapy
- Patients with combined second primary breast cancer and other primary malignant tumors
- Patients with symptomatic brain metastases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130021
xu sun
About this study
Official title: A Real-world Study of the Efficacy and Safety of Amlotinib for the Treatment of HER2-negative Advanced Breast Cancer
This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications.
Read the detailed description
The sample size was calculated according to the One-Sample Log-rank Test.During the treatment of amlotinib, metastatic site imaging was performed every 2-3 cycles, and the efficacy assessment and safety information were collected according to the RECIST version 1.1 criteria. After the completion of amlotinib treatment, survival follow-up was continued to clarify the survival status of the patients. When descriptive statistical analyses of clinicopathological characteristics were performed, categorical information was described by frequency counts and constitutive ratios, and quantitative information, such as conforming to normal distribution, was described by mean ± standard deviation, and not conforming to normal distribution, was described by median and interquartile spacing. Progression-free survival and overall survival at each time point were calculated by the Kaplan-Meier method and plotted as survival curves, Log-rank test was used to compare the prognostic differences between groups of latent variables, and the prognostic impact of latent variables on the anilotinib-treated patients was analysed using the COX regression risk model for exploratory analysis, and the risk ratios (hazard ratios (HRs) for quantitative evaluation. Variables with p-values less than 0.1 in the univariate COX regression analyses were screened by stepwise regression into the multivariate COX regression analyses. If the lapse rate exceeded 20%, sensitivity analyses were used to assess the impact of the lapse on the endpoint outcome event, which was performed by assuming a death outcome for the study subjects who were lost and analysing the endpoint event, and then treating the lost patients as normal and analysing the endpoint event and assessing the impact of the lost patients on the endpoint event. spss version 21.0 was used for the statistics, and a p<0.05 was considered to be clinically significant.
- Conditions
- Breast Cancer
- Being tested
- Anlotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Anrotinib is available in 12 mg, 10 mg, and 8 mg doses. The recommended dose of Anrotinib is 12 mg taken by mouth once daily, continuously, for 2 weeks on and 1 week off, in a 21-day cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-FreeSurvival
Measured: Incorporation January 2021 through November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start4 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 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.
- More trials run by The First Hospital of Jilin 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340165
- Sponsor's protocol ID
- 2023-KS-151
- Status last verified
- Feb 2024
- First submitted
- 1 Jan 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Efficacy and Safety of Amlotinib for the Treatment of HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06340165
- Acronym / sponsor ID
- 2023-KS-151
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Apr 2024 (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 analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications.
Detailed description
The sample size was calculated according to the One-Sample Log-rank Test.During the treatment of amlotinib, metastatic site imaging was performed every 2-3 cycles, and the efficacy assessment and safety information were collected according to the RECIST version 1.1 criteria. After the completion of amlotinib treatment, survival follow-up was continued to clarify the survival status of the patients. When descriptive statistical analyses of clinicopathological characteristics were performed, categorical information was described by frequency counts and constitutive ratios, and quantitative information, such as conforming to normal distribution, was described by mean ± standard deviation, and not conforming to normal distribution, was described by median and interquartile spacing. Progression-free survival and overall survival at each time point were calculated by the Kaplan-Meier method and plotted as survival curves, Log-rank test was used to compare the prognostic differences between groups of latent variables, and the prognostic impact of latent variables on the anilotinib-treated patients was analysed using the COX regression risk model for exploratory analysis, and the risk ratios (hazard ratios (HRs) for quantitative evaluation. Variables with p-values less than 0.1 in the univariate COX regression analyses were screened by stepwise regression into the multivariate COX regression analyses. If the lapse rate exceeded 20%, sensitivity analyses were used to assess the impact of the lapse on the endpoint outcome event, which was performed by assuming a death outcome for the study subjects who were lost and analysing the endpoint event, and then treating the lost patients as normal and analysing the endpoint event and assessing the impact of the lost patients on the endpoint event. spss version 21.0 was used for the statistics, and a p<0.05 was considered to be clinically significant.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective cohort study to collect clinical data of patients with HER-2 negative advanced breast cancer treated with amrutinib at four centers four centers at the First Hospital of Jilin University, Liaoning Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, and Peking University Cancer Hospital between 2019.1 and 2022.9
Key inclusion criteria (4 listed)
- Imaging or tissue/cell puncture, etc. confirmed recurrent, metastatic breast cancer
- Pathologically confirmed HER-2 negative
- Application of amlotinib treatment until disease progression or toxicity intolerable, or voluntarily give up the continuation of amlotinib treatment,amlotinib application for at least 2 cycles
- The clinical data are basically complete
Key exclusion criteria (3 listed)
- Patients receiving local treatment means such as surgery and radiotherapy
- Patients with combined second primary breast cancer and other primary malignant tumors
- Patients with symptomatic brain metastases
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 |
|---|---|---|
| AnlotinibAnrotinib is available in 12 mg, 10 mg, and 8 mg doses. The recommended dose of Anrotinib is 12 mg taken by mouth once daily, continuously, for 2 weeks on and 1 week off, in a 21-day cycle. | Drug | – |
Primary outcome
PFS
Time frame: Incorporation January 2021 through November 2023
Progression-FreeSurvival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The First Hospital of Jilin University 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 4 inclusion and 3 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 1 Apr 2024. 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?
Contact Jiuwei Cui (15843073215, jdyycjw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Incorporation January 2021 through November 2023). 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 1 Apr 2024.