Breast CancerNCT06015126
Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
A study testing metronomic oral vinorelbine plus anlotinib in people with Breast Cancer, run by Yan Xue at 1 site in China.
Trial summary
vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic 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?
- metronomic oral vinorelbine plus anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2022to Jan 2026
- 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
- Voluntarily sign an informed consent form;
- Females aged 18 years or older;
- ECOG physical performance status score of 0-2;
- Histologically confirmed HER2-negative metastatic breast cancer patients, and patients with locally recurrent disease who cannot undergo curative surgery or radiation therapy;
- HR-positive/HER2-negative advanced breast cancer patients who have primary endocrine resistance or disease progression after first-line endocrine ± targeted therapy;
- Triple-negative advanced breast cancer patients with disease progression after first-line chemotherapy ± immunotherapy;
Show all 10Show fewer
- Blood routine examination meets the following conditions: ①absolute neutrophil count (ANC) ≥1.5×10^9/L, ② platelets ≥100×10^9/L, ③ hemoglobin ≥90 g/L, ④ white blood cell count ≥3.0×10^9/L;
- The liver function meets the following criteria: ① serum total bilirubin ≤ 1.5 × ULN, and if there is liver metastasis, it should be ≤ 3 × ULN; ② AST or ALT ≤ 3 × ULN, and if there is liver metastasis, it should be ≤ 5 × ULN;
- The renal function meets the following criteria: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated according to the Cockroft-Gault formula);
- Female patients who meet the following criteria can participate in this study: ① Patients are not capable of reproduction; ② Patients have reproductive capacity, and have a negative result on the pregnancy test within 7 days before the first administration of the investigational drug, are not in the lactation period, and continuously adopt effective contraceptive measures before entering the study and during the entire study period and within 6 months after the last administration of the investigational drug.
Who cannot join
- Patients who have previously received treatment with vinorelbine and/or anlotinib;
- Patients with active or untreated brain metastasis;
- Patients who have had or currently have other malignancies within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades basement membrane)];
- Patients who have undergone major surgery (including thoracotomy biopsy) or suffered a significant trauma (such as bone fracture) within 4 weeks before randomization, have unhealed wounds or fractures at the time of screening, or are expected to undergo major surgery during the study period;
- Patients with a history of myocardial infarction within the past 6 months; history of congestive heart failure with New York Heart Association (NYHA) classification ≥ II, or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventricular tachycardia) that cannot be controlled by medication;
- Patients with known allergies to the drugs and their excipients involved in this trial;
Show all 10Show fewer
- Patients with a known history of hypersensitivity reactions to any investigational drugs;
- Patients who are simultaneously participating in other trials;
- Patients who cannot evaluate the efficacy of the treatment plan with existing technology;
- Patients judged unsuitable for participation by other investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100
Yan Xue, 0086-13992830596, 1410605462@qq.com
About this study
vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has been the subject of several clinical studies, with proven effectiveness and good safety, showing great prospects for application.
Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for the treatment of HER2-negative advanced breast cancer.
Read the detailed description
Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer.
Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib: 12mg/capsule, 10mg/capsule, 8mg/capsule
Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer, and to provide new data for later-line treatment of HER2-negative advanced breast cancer.
Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 60 patients.
- Conditions
- Breast Cancer
- Being tested
- metronomic oral vinorelbine plus 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.
metronomic oral vinorelbine plus anlotinibDrug
To clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Label 1 | Experimental | metronomic oral vinorelbine plus anlotinib Receives: Drug: metronomic oral vinorelbine plus anlotinib |
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: 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
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 start5 Oct 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06015126
- Sponsor's protocol ID
- Y-pierrefabre202102-0108
- 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
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 Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06015126
- Acronym / sponsor ID
- Y-pierrefabre202102-0108
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yan XueUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (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.
vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has been the subject of several clinical studies, with proven effectiveness and good safety, showing great prospects for application.
Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for the treatment of HER2-negative advanced breast cancer.
Detailed description
Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer.
Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib: 12mg/capsule, 10mg/capsule, 8mg/capsule
Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer, and to provide new data for later-line treatment of HER2-negative advanced breast cancer.
Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 60 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: metronomic oral vinorelbine plus anlotinibmetronomic oral vinorelbine plus anlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily sign an informed consent form;
- Females aged 18 years or older;
- ECOG physical performance status score of 0-2;
- Histologically confirmed HER2-negative metastatic breast cancer patients, and patients with locally recurrent disease who cannot undergo curative surgery or radiation therapy;
- HR-positive/HER2-negative advanced breast cancer patients who have primary endocrine resistance or disease progression after first-line endocrine ± targeted therapy;
Key exclusion criteria (10 listed)
- Patients who have previously received treatment with vinorelbine and/or anlotinib;
- Patients with active or untreated brain metastasis;
- Patients who have had or currently have other malignancies within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades basement membrane)];
- Patients who have undergone major surgery (including thoracotomy biopsy) or suffered a significant trauma (such as bone fracture) within 4 weeks before randomization, have unhealed wounds or fractures at the time of screening, or are expected to undergo major surgery during the study period;
- Patients with a history of myocardial infarction within the past 6 months; history of congestive heart failure with New York Heart Association (NYHA) classification ≥ II, or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventricular tachycardia) that cannot be controlled by medication;
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 |
|---|---|---|
| metronomic oral vinorelbine plus anlotinibTo clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer | 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: 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
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.
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.
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 metronomic oral vinorelbine plus anlotinib 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 10 inclusion and 10 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?
Contact Yan Xue (0086-13992830596, 1410605462@qq.com), 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 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.