Breast CancerPhase 2NCT06678230
Clinical Trial of Eribulin in Combination with Anrotinib for HER-2 Negative Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing Anlotinib in people with Breast Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Study Objective: To evaluate the progression-free survival of HER-2 negative locally advanced or metastatic breast cancer subjects treated with eribulin in combination with erlotinib Trial Drug: Erlotinib Targets: Erlotinib is a novel small-molecule multi-targeted tyrosine kinase inhibitor, which can inhibit the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to 20 Oct 2025
- Phase
- Phase 2
- 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
Who may be able to join
- histologically or cytologically confirmed breast cancer.
- immunohistochemistry HER-2 negative at this center
- subjects with locally recurrent or metastatic breast cancer who have received chemotherapy with anthracyclines and paclitaxel prior to the current chemotherapy regimen. Treatment prior to study entry must meet the following criteria: a. The regimen must include anthracyclines (e.g., doxorubicin, epirubicin, piroxicam) and paclitaxel (e.g., paclitaxel, docetaxel) in any combination or other order of administration. If these drugs are contraindicated in the intended subject, prior use of these drugs in prior therapy is not required but is documented in the subject\'s medical history. b. Some of these regimens may be used as adjuvant and/or neoadjuvant therapies, and subjects may also have been previously treated with anti-estrogenic agents. c. ≤2 lines of chemotherapy targeting recurrent/metastatic lesions: i Anthracyclines and paclitaxel adjuvant therapy within 12 months of progression; ii progression on advanced first/second line therapy; iii subjects must have demonstrated disease progression on the most recent chemotherapy.
- Endocrine therapy targeting recurrent/metastatic lesions will not be counted towards the number of lines of therapy.
- Measurable lesions meet the following criteria:Exclusion Criteria:a. At least one lesion with a longest diameter ≥1.0 cm for non-lymph nodes or a short-axis diameter ≥1.5 cm for lymph nodes, which can be measured serially using computed tomography/magnetic resonance imaging (CT/MRI) according to RECIST 1.1. b. If only one target lesion is non-lymph node, its longest diameter should be ≥1.5 cm. Physical Status Score ≤ 2.
- Age ≥ 18 and ≤ 70 years at the time of signing the informed consent form.
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- Appropriate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL, or serum creatinine clearance ≥ 40 mL/min according to the Cockcroft-Gault formula.
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L as evidence of adequate bone marrow function.
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN); and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3.0 times the ULN (≤ 5.0 times the ULN in the case of hepatic metastases) as evidence of adequate bone marrow function. 5.0 times upper limit of normal) as evidence of appropriate liver function.
- Subjects are willing and able to comply with the study protocol throughout the study period.
- All female subjects will be considered of childbearing potential unless postmenopausal (at least 12 consecutive months of amenorrhea, in the appropriate age group, and with no other known or suspected cause) or surgically sterilized (i.e., ≥1 menstrual cycle of bilateral tubal ligation, or hysterectomy and/or bilateral oophorectomy prior to randomization). Female subjects of childbearing potential must agree to use two highly effective methods of contraception beginning with their last menstrual period prior to randomization grouping (or until two highly effective methods of contraception have been used for at least one menstrual cycle using the double-barrier method described below), during the study period, and for a period of 3 months after the final dose of study treatment. Female subjects exempted from this requirement were subjects who were completely abstinent. If currently abstinent, the subject must agree to use a double barrier method of contraception (i.e., condom with spermicide and an occlusive cap (uterine cap or cervical/vault cap)) if she becomes sexually active during the study treatment period, or two highly effective methods of contraception for at least one menstrual cycle and until 3 months after the final dose of study treatment. Highly effective methods of contraception include: a. Implantable intrauterine device (IUD) or contraceptive system, b. Barrier methods of contraception: spermicide-containing condom or occlusive cap (uterine cap or cervix/fornix cap), and c. Recognized hormonal contraceptive methods: oral, injectable, or implantable. Female subjects using hormonal contraceptives must receive a stable dose of the same hormonal contraceptive product from the last menstrual period prior to randomization and must continue to use the same hormonal contraceptive product for the duration of the study treatment as well as for 3 months after the final dose of study treatment, d. Confirmed azoospermic vasectomy partner.
- Voluntarily agrees to, and signs, a written informed consent form, and is willing and able to comply with all aspects of the trial protocol, and the patient may withdraw consent at any time without prejudice.
Who cannot join
- previous neoadjuvant or adjuvant therapy containing eribulin (anitrotinib may have been applied)
- patients in whom anitrotinib is contraindicated.
- patients with active symptomatic brain metastases or meningeal metastases.
- patients with active/refractory infections requiring ongoing anti-infective therapy.
- pulmonary lymphovascular dissemination resulting in pulmonary dysfunction requiring active therapy, including the use of oxygen.
- severe cardiovascular impairment (history of congestive heart failure greater than New York Heart Association (NYHA) class II), unstable angina pectoris or myocardial infarction within the past 6 months, or severe cardiac arrhythmias.
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- Subjects with allogeneic organ transplants requiring immunosuppressive therapy.
- Subjects known to be positive for Human Immunodeficiency Virus (HIV).
- Subjects with prior malignant tumors other than breast, cervical carcinoma in situ, and non-melanoma skin cancer. Subjects with a prior malignancy other than breast cancer and non-melanoma skin cancer, unless the prior malignancy has been previously diagnosed and definitively treated for at least 5 years without evidence of subsequent recurrence.
- Subjects with pre-existing neuropathy \> Grade 2.
- Subjects with hypersensitivity to chondroitin B and/or chemical derivatives of chondroitin B.
- Any medical condition that, in the opinion of the Investigator, makes a subject ineligible for entry into the study.
- Subjects with a known human immunodeficiency virus (HIV)-positive condition.
- Subjects with a known human immunodeficiency virus (HIV)-positive condition.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Center, The First Affiliated Hospital of Jilin University, Changchun, Jilin Province, China
Changchun, Jilin, 130021
jiuwei Cui, 15843073215, jdyycjw@163.com
xu sun
About this study
Official title: Multicenter, Single-Arm, Phase II Clinical Trial of Eribulin in Combination with Anrotinib for HER-2 Negative Locally Advanced or Metastatic Breast Cancer.
Study Objective: To evaluate the progression-free survival of HER-2 negative locally advanced or metastatic breast cancer subjects treated with eribulin in combination with erlotinib Trial Drug: Erlotinib Targets: Erlotinib is a novel small-molecule multi-targeted tyrosine kinase inhibitor, which can inhibit the kinase activities of vascular endothelial growth factor receptor (VEGFR1-3), platelet-derived growth factor receptor (PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor, etc., and thus exert anti-tumor angiogenesis, thereby exerting anti-tumor angiogenesis and anti-vascularity. PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor and other kinase activities, and then play the role of anti-tumor angiogenesis and inhibition of tumor growth. Results of previous studies, known efficacy and adverse effects: The single-agent regimen of amlotinib has been clinically approved in non-small cell lung cancer, gastric cancer, and soft tissue sarcoma. In breast cancer, the II clinical study of amlotinib monotherapy for the treatment of HER-2 negative advanced breast cancer in the second line and above showed that the PFS of amlotinib monotherapy was 5.22 months, ORR was 15.4%, and DCR was 80.8%, which demonstrated that amlotinib has better anti-tumor activity. Major adverse reactions: fatigue, weight loss, hypertension, diarrhea, nausea, vomiting, hematemesis
Read the detailed description
This is a single-arm, single-center, Phase II clinical trial of eribulin in combination with amlotinib in subjects with HER-2 negative locally advanced or metastatic breast cancer.
The trial is planned to enroll 40 subjects with HER-2 negative locally advanced or metastatic breast cancer who have received prior chemotherapy with anthracycline and paclitaxel-based agents to receive eribulin in combination with erlotinib.
Trial drug: eribulin 1.4 mg/m2, D1,8; one cycle every 3 weeks; Amlotinib 12 mg, QD, po, applied for 14 days and stopped for 7 days, one cycle every 3 weeks.
All subjects will receive long-term dosing until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this trial (meaning completion of the trial or early termination of the trial).
During the treatment period, all subjects will be evaluated for antitumor efficacy every 6 weeks and disease status will be determined by the investigator according to RECIST 1.1 criteria until disease progression or death or refusal to come to the hospital for follow-up or the end of the trial (meaning completion of the trial or early termination of the trial), whichever event occurs first. After a subject\'s disease progression or refusal to come to the hospital for follow-up, the investigator will make a telephone visit every 3 months (each month will be counted as 30 days) to obtain information about the subject\'s survival, whether he/she is receiving other antitumor therapy, etc.
- Conditions
- Breast Cancer
- Being tested
- Anlotinib
- Keywords
- Eribulin, 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
Also called Eribulin
Alibulin 1.4mg/m2, D1, 8; Every 3 weeks is a cycle; Androtinib 12mg, QD, po, applied for 14 days, stopped for 7 days, and every 3 weeks was a cycle.
| Study group | Role | What they receive |
|---|---|---|
| This is a single-arm, single-center, phase II clinical trial of eribulin in combination with erlotin | Experimental | This trial is planned to enroll 40 subjects with HER-2 negative locally advanced or metastatic breast cancer who have received prior chemotherapy with anthracyclines and paclitaxel, treated with eribulin in combination with erlotinib.
Trial drug: eribulin 1.4 mg/m2, D1,8; one cycle every 3 weeks; Amlotinib 12 mg, QD, po, applied for 14 days and stopped for 7 days, one cycle every 3 weeks.
All subjects will receive long-term dosing until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this trial (meaning completion of the trial or early termination of the trial).
During the treatment period, all subjects will be evaluated for antitumor efficacy every 6 weeks and disease status will be determined by the investigator according to RECIST 1.1 criteria until disease progression or death or refusal to come to the hospital for follow-up or the end of the trial (meaning completion of the trial or early termination of the trial), whichever event occurs Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS, commonly referred to in medicine as progression-free survival, is the main indicator used to measure the effectiveness of agents used to treat a tumour during the course of treatment, and is commonly used to assess the treatment of cancer patients, with a strong correlation to overall survival, usually measured in months.
Measured: up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startNov 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion20 Oct 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Alibulin 1.4mg/m2, D1, 8; Every 3 weeks is a cycle; Androtinib 12mg, QD, po, applied for 14 days, stopped for 7 days, and every 3 weeks was a cycle.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06678230
- Sponsor's protocol ID
- 2023-HS-061
- Status last verified
- Dec 2023
- First submitted
- 1 Jan 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-Arm, Phase II Clinical Trial of Eribulin in Combination with Anrotinib for HER-2 Negative Locally Advanced or Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT06678230
- Acronym / sponsor ID
- 2023-HS-061
- Conditions
- Breast Cancer
- Keywords
- Eribulin, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 7 Nov 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.
Study Objective: To evaluate the progression-free survival of HER-2 negative locally advanced or metastatic breast cancer subjects treated with eribulin in combination with erlotinib Trial Drug: Erlotinib Targets: Erlotinib is a novel small-molecule multi-targeted tyrosine kinase inhibitor, which can inhibit the kinase activities of vascular endothelial growth factor receptor (VEGFR1-3), platelet-derived growth factor receptor (PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor, etc., and thus exert anti-tumor angiogenesis, thereby exerting anti-tumor angiogenesis and anti-vascularity. PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor and other kinase activities, and then play the role of anti-tumor angiogenesis and inhibition of tumor growth. Results of previous studies, known efficacy and adverse effects: The single-agent regimen of amlotinib has been clinically approved in non-small cell lung cancer, gastric cancer, and soft tissue sarcoma. In breast cancer, the II clinical study of amlotinib monotherapy for the treatment of HER-2 negative advanced breast cancer in the second line and above showed that the PFS of amlotinib monotherapy was 5.22 months, ORR was 15.4%, and DCR was 80.8%, which demonstrated that amlotinib has better anti-tumor activity. Major adverse reactions: fatigue, weight loss, hypertension, diarrhea, nausea, vomiting, hematemesis
Detailed description
This is a single-arm, single-center, Phase II clinical trial of eribulin in combination with amlotinib in subjects with HER-2 negative locally advanced or metastatic breast cancer.
The trial is planned to enroll 40 subjects with HER-2 negative locally advanced or metastatic breast cancer who have received prior chemotherapy with anthracycline and paclitaxel-based agents to receive eribulin in combination with erlotinib.
Trial drug: eribulin 1.4 mg/m2, D1,8; one cycle every 3 weeks; Amlotinib 12 mg, QD, po, applied for 14 days and stopped for 7 days, one cycle every 3 weeks.
All subjects will receive long-term dosing until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this trial (meaning completion of the trial or early termination of the trial).
During the treatment period, all subjects will be evaluated for antitumor efficacy every 6 weeks and disease status will be determined by the investigator according to RECIST 1.1 criteria until disease progression or death or refusal to come to the hospital for follow-up or the end of the trial (meaning completion of the trial or early termination of the trial), whichever event occurs first. After a subject\'s disease progression or refusal to come to the hospital for follow-up, the investigator will make a telephone visit every 3 months (each month will be counted as 30 days) to obtain information about the subject\'s survival, whether he/she is receiving other antitumor therapy, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Alibulin 1.4mg/m2, D1, 8; Every 3 weeks is a cycle; Androtinib 12mg, QD, po, applied for 14 days, stopped for 7 days, and every 3 weeks was a cycle.
| Arm | Type | Receives |
|---|---|---|
| This is a single-arm, single-center, phase II clinical trial of eribulin in combination with erlotin | Experimental | Drug: AnlotinibThis trial is planned to enroll 40 subjects with HER-2 negative locally advanced or metastatic breast cancer who have received prior chemotherapy with anthracyclines and paclitaxel, treated with eribulin in combination with erlotinib. Trial drug: eribulin 1.4 mg/m2, D1,8; one cycle every 3 weeks; Amlotinib 12 mg, QD, po, applied for 14 days and stopped for 7 days, one cycle every 3 weeks. All subjects will receive long-term dosing until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this trial (meaning completion of the trial or early termination of the trial). During the treatment period, all subjects will be evaluated for antitumor efficacy every 6 weeks and disease status will be determined by the investigator according to RECIST 1.1 criteria until disease progression or death or refusal to come to the hospital for follow-up or the end of the trial (meaning completion of the trial or early termination of the trial), whichever event occurs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- histologically or cytologically confirmed breast cancer.
- immunohistochemistry HER-2 negative at this center
- subjects with locally recurrent or metastatic breast cancer who have received chemotherapy with anthracyclines and paclitaxel prior to the current chemotherapy regimen. Treatment prior to study entry must meet the following criteria: a. The regimen must include anthracyclines (e.g., doxorubicin, epirubicin, piroxicam) and paclitaxel (e.g., paclitaxel, docetaxel) in any combination or other order of administration. If these drugs are contraindicated in the intended subject, prior use of these drugs in prior therapy is not required but is documented in the subject\'s medical history. b. Some of these regimens may be used as adjuvant and/or neoadjuvant therapies, and subjects may also have been previously treated with anti-estrogenic agents. c. ≤2 lines of chemotherapy targeting recurrent/metastatic lesions: i Anthracyclines and paclitaxel adjuvant therapy within 12 months of progression; ii progression on advanced first/second line therapy; iii subjects must have demonstrated disease progression on the most recent chemotherapy.
- Endocrine therapy targeting recurrent/metastatic lesions will not be counted towards the number of lines of therapy.
- Measurable lesions meet the following criteria:Exclusion Criteria:a. At least one lesion with a longest diameter ≥1.0 cm for non-lymph nodes or a short-axis diameter ≥1.5 cm for lymph nodes, which can be measured serially using computed tomography/magnetic resonance imaging (CT/MRI) according to RECIST 1.1. b. If only one target lesion is non-lymph node, its longest diameter should be ≥1.5 cm. Physical Status Score ≤ 2.
Key exclusion criteria (14 listed)
- previous neoadjuvant or adjuvant therapy containing eribulin (anitrotinib may have been applied)
- patients in whom anitrotinib is contraindicated.
- patients with active symptomatic brain metastases or meningeal metastases.
- patients with active/refractory infections requiring ongoing anti-infective therapy.
- pulmonary lymphovascular dissemination resulting in pulmonary dysfunction requiring active therapy, including the use of oxygen.
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 |
|---|---|---|
| AnlotinibAlso: EribulinAlibulin 1.4mg/m2, D1, 8; Every 3 weeks is a cycle; Androtinib 12mg, QD, po, applied for 14 days, stopped for 7 days, and every 3 weeks was a cycle. | Drug | This is a single-arm, single-center, phase II clinical trial of eribulin in combination with erlotin |
Primary outcome
PFS
Time frame: up to 33 months
PFS, commonly referred to in medicine as progression-free survival, is the main indicator used to measure the effectiveness of agents used to treat a tumour during the course of treatment, and is commonly used to assess the treatment of cancer patients, with a strong correlation to overall survival, usually measured in months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- 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. 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?
A Phase 2 study testing Anlotinib in people with 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 12 inclusion and 14 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 7 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zheng Lv (15804301705, lvz@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 33 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 7 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.