Breast CancerNCT06373744
Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients
An observational study of Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is: How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy. 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?
- cyclophosphamide , methotrexate , vinorelbine ,capecitabine
- How many people
- 597 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Advanced breast cancer taking metronomic chemotherapy
Who may be able to join
- Females, >18 years old;
- Diagnosed with advanced breast cancer when using metronomic chemotherapy;
- At least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. Examinations include ultrasound, computed tomography, and magnetic resonance imaging;
- Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
- The clinical pathological information that needs to be collected is complete.
Who cannot join
- Taking the drug for less than 2 weeks;
- losing follow-up after taking the therapy;
- The patient's breast cancer was still in the early stage when taking the therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:
How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide , methotrexate , vinorelbine ,capecitabine
- Keywords
- breast cancer, metronomic chemotherapy, 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.
cyclophosphamide , methotrexate , vinorelbine ,capecitabineDrug
The drugs used in metronomic chemotherapy are cyclophosphamide (CTX), methotrexate (M), vinorelbine (VNR), and capecitabine
| Study group | Role | What they receive |
|---|---|---|
| metronomic chemotherapy | Patients with advanced breast cancer who received metronomic chemotherapy. Receives: Drug: cyclophosphamide , methotrexate , vinorelbine ,capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression
Measured: Baseline up to approximately 20 months
Secondary outcomes (3)
Overall Survival
Time from randomization to date of death due to any cause
Measured: Baseline until death (up to approximately 40 months)
Objective Response Rate
Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause.
Measured: Baseline up to approximately 20 months
Disease Control Rate
Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) >24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.
Measured: Baseline up to approximately 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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 Sun Yat-sen 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
- Investigators
- Shusen Wang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373744
- Sponsor's protocol ID
- SYSU-022
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06373744
- Acronym / sponsor ID
- SYSU-022
- Conditions
- Breast Cancer
- Keywords
- breast cancer, metronomic chemotherapy, capecitabine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 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.
The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:
How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metronomic chemotherapy | – | Drug: cyclophosphamide , methotrexate , vinorelbine ,capecitabinePatients with advanced breast cancer who received metronomic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced breast cancer taking metronomic chemotherapy
Key inclusion criteria (5 listed)
- Females, >18 years old;
- Diagnosed with advanced breast cancer when using metronomic chemotherapy;
- At least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. Examinations include ultrasound, computed tomography, and magnetic resonance imaging;
- Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
- The clinical pathological information that needs to be collected is complete.
Key exclusion criteria (3 listed)
- Taking the drug for less than 2 weeks;
- losing follow-up after taking the therapy;
- The patient's breast cancer was still in the early stage when taking the therapy.
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 |
|---|---|---|
| cyclophosphamide , methotrexate , vinorelbine ,capecitabineThe drugs used in metronomic chemotherapy are cyclophosphamide (CTX), methotrexate (M), vinorelbine (VNR), and capecitabine | Drug | metronomic chemotherapy |
Primary outcome
Progression free survival
Time frame: Baseline up to approximately 20 months
Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression
3 secondary outcomes
Overall Survival
Time frame: Baseline until death (up to approximately 40 months)
Objective Response Rate
Time frame: Baseline up to approximately 20 months
Disease Control Rate
Time frame: Baseline up to approximately 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Shusen Wang, MD principal investigator
Sun Yat-sen University
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 Sun Yat-sen 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 5 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: finished, as of the sponsor's last update on 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Baseline up to approximately 20 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 18 Apr 2024.