- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05296577
Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer
September 22, 2023 updated by: Min Yan, MD, Henan Cancer Hospital
A Controlled, Phase II Study of Anlotinib vs Placebo Combination With Vinorelbine for the Treatment of HER2- Advanced Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with vinorelbine in the treatment of HER2- advanced breast cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The eligible patients were HER2 negative advanced breast cancer patients who experienced failure of previous treatments with anthracyclines and/or taxanes , or hormone receptor-positive HER2-negative advanced breast cancer patients who progressed after at least first-line endocrine therapy in the advanced stage.The enrolled patients would receive anlotinib 12mg orally (2 weeks on/1 week off ,Q3W) plus vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle) or vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle).Imaging will be performed after the twice anlotinib administration as 2 cycles.This study is a randomized controlled, phase II clinical trial, and the treatment continued until radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.
Study Type
Interventional
Enrollment (Estimated)
134
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huimin Lv
- Email: lvhuimin999@163.com
Study Contact Backup
- Name: min yan
- Phone Number: 15713857388
- Email: ym200678@126.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- Henan Cancer Hospital
-
Contact:
- Min Yan, Professor
- Phone Number: +86 15713857388
- Email: ym200678@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Patients voluntarily participated in the study and signed informed consent;
- 2. Women aged 18 or older;
- 3. The number of treatment lines shall not exceed 4 lines;
- 4. Patients with locally advanced or metastatic breast cancer diagnosed as HER2-negative by molecular typing;
- 5. Enrolled patients were HER2-negative breast cancer patients who had failed to prior taxane and/or anthracycline therapy, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed with at least prior first-line endocrine therapy;
- 6. ECOG score is 0 or 1, and the expected survival is not less than 3 months;
- 7. Patients with measurable lesions as defined in RECIST1.1 criteria;
- 8. The main organs function well, and the laboratory test indexes meet the following requirements:(1) Routine blood test (no blood transfusion or hematopoietic stimulating factor was used within 7 days before screening) :① Hemoglobin (HB) ≥ 90g/L;② Absolute neutrophil count (ANC) ≥1.5×109/L;③ Platelet (PLT) ≥ 80×109/L;(2) Blood biochemical test (no blood transfusion or albumin within 7 days before screening) :① ALT and AST ≤2.5 × ULN (liver/bone metastasis ≤5 × ULN; Bone metastases ≤5 ULN);② Serum total bilirubin (TBIL) ≤1.5 × ULN;③ Serum Cr≤1.5×ULN or creatinine clearance ≥60 mL /min;(3) Coagulation function test:① Activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;② Doppler ultrasound assessment: left entricular ejection fraction (LVE F)≥ 50%;
- 9. The patient has the ability to take medication orally;
- 10. Any toxic side effects of previous chemotherapy have been recovered to ≤CTCAE1 or baseline level;
- 11. Women of reproductive age must agree to use a highly effective method of contraception during the study period and for 6 months after the last administration of the study drug; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;
Exclusion Criteria:
- 1. Prior treatment with bevacizumab, anlotinib and other antiangiogenic agents;
- 2. Patients who had previously used Vinorelbine with an interval time of less than 6 months from the end of medication;
- 3. Interval of less than 3 weeks after radiotherapy or chemotherapy; The interval after endocrine therapy was less than 1 week;
- 4. Associated diseases/history;(1) Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml per day); Or bleeding symptoms of significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation and above, or suffering from vasculitis, etc.;(2) Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except those who had been cured after intravenous catheterization due to chemotherapy) and pulmonary embolism, etc.;(3) hypertension, which cannot be well controlled by antihypertensive drug therapy (systolic blood pressure & GT; 140 mmHg or diastolic pressure > 90 mmHg); During the first 6 months of randomization, myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant ventricular arrhythmias or ventricular arrhythmias, and symptomatic congestive heart failure;(4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g., diabetes, pulmonary fibrosis and acute pneumonia);(5) Renal insufficiency: urine protein ≥ ++ indicated by routine urine examination, or confirmed 24-hour urine protein level ≥1.0g;(6) History of live attenuated vaccine vaccination within 28 days prior to initial study administration or expected live attenuated vaccine vaccination during study period;(7) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ mL; Hepatitis C, defined as hcV-RNA higher than the lower limit of assay) or co-infection with hepatitis B and c;(8) Severe infection, including but not limited to bacteremia and severe pneumonia requiring hospitalization, occurred within 4 weeks before the first administration; Active CTCAE grade 5.0≥2 infection requiring systemic antibiotic treatment within 2 weeks prior to initial administration or unexplained fever during screening/prior to initial administration > 38.5°C (according to the investigator's judgment, fever caused by tumor can be included in the group); Evidence of active tuberculosis infection within 1 year before administration;
- 5. Have been diagnosed with any other malignant tumor within 3 years prior to entering the study;
- 6. Thyroid dysfunction;
- 7. Major operations were performed within 28 days before enrollment, and minor operations were performed within 14 days before enrollment;
- 8. Subjects who have received or are planning to receive allogeneic bone marrow transplantation or solid organ transplantation;
- 9. Peripheral neuropathy ≥ grade 2; Patients with active brain metastases, cancerous meningitis, spinal cord compression, or diseases of the brain or pia meningiae found by imaging CT or MRI examination at the time of screening (patients with brain metastases who had completed treatment 14 days before enrollment and had stable symptoms could be enrolled, but were confirmed to have no symptoms of cerebral hemorrhage by craniocerebral MRI, CT or venography evaluation);
- 10. There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and the presence of clinically significant intestinal obstruction.
- 11. Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study period.
- 12. Patients with other serious physical or mental disorders or abnormal laboratory tests that may increase the risk of study participation or interfere with study results, and who are considered unsuitable for study participation by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anlotinib and vinorelbine
anlotinib combined with vinorelbine
|
anlotinib 12mg orally ,2 weeks on/1 week off ,Q3W; vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.
Other Names:
|
Placebo Comparator: vinorelbine
placebo and vinorelbine
|
vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: up to 24 months
|
progression-free survival
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: up to 24 months
|
Objective Response Rate
|
up to 24 months
|
OS
Time Frame: up to 24 months
|
overall survival
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: min yan, Henan Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2022
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANLO-BC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.
IPD Sharing Time Frame
five years after publication
IPD Sharing Access Criteria
Please contact Central contact person by Email
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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