HER 2 Negative Breast CancerPhase 2MBC-EANCT07520760
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates
A Phase 2 study testing Eribulin in Combination with Anlotinib in people with HER 2 Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER 2 Negative Breast Cancer
- What is being tested?
- Eribulin in Combination with Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Apr 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Female patients aged ≥ 18 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- HER2-negative status, defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative HER2 gene amplification by fluorescence in situ hybridization (FISH). If multiple specimens have been tested, the most recent test result will be used for determination.
- Prior treatment with anthracycline- or taxane-containing chemotherapy, including in the neoadjuvant or adjuvant setting.
- Intolerance or disease progression following prior treatment with an antibody-drug conjugate (ADC), without the initiation of a new treatment regimen after ADC therapy.
- Received no more than 4 prior lines (including 4 lines) of chemotherapy.
- At least one measurable lesion per RECIST v1.1.
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- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Adequate major organ function as defined by the following criteria:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 75 × 10⁹/L, hemoglobin (Hb) ≥ 85 g/L (without transfusion or blood product support, or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).
- Biochemistry: Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1 × ULN, or calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula).
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment. Women not of childbearing potential (i.e., surgically sterile or postmenopausal for at least 1 year) are eligible without requiring contraception.
- Willing and able to provide written informed consent, with good compliance and willingness to complete scheduled follow-up.
Who cannot join
- Untreated active brain metastases. Patients with asymptomatic central nervous system (CNS) metastases or those with stable brain metastases following radiotherapy are eligible.
- Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, except for patients who have been stable for at least 1 month after treatment and have discontinued corticosteroids for > 2 weeks.
- HER2-positive status, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with positive HER2 gene amplification by fluorescence in situ hybridization (FISH). Patients with a prior HER2-positive status but who are HER2-negative per the most recent pathology test are eligible.
- History of clinically significant cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric diseases.
- Acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive and/or hepatitis B core antibody [HBcAb] positive with hepatitis B virus [HBV] DNA copy number ≥ 1 × 10³ copies/mL or ≥ 200 IU/mL) or acute or chronic active hepatitis C (hepatitis C virus [HCV] antibody positive). Patients with positive HCV antibody but negative HCV RNA are eligible.
- Receipt of anti-tumor monoclonal antibody therapy within 4 weeks prior to study initiation, or prior treatment with other anti-tumor therapies with unresolved adverse events/reactions.
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- Known inherited or acquired bleeding tendencies (e.g., hemophilia, coagulation disorders, etc.).
- History or evidence of any disease, condition, treatment, or laboratory abnormality that may interfere with the study results or preclude the patient's full participation in the study, or any other condition deemed unsuitable for enrollment by the investigator.
- Any severe underlying disease, comorbidity, or active infection.
- Concurrent receipt of other anti-tumor therapy.
- History of epilepsy or conditions predisposing to seizure.
- Pregnant or breastfeeding women.
- Poor compliance or inability to complete scheduled follow-up.
- Known hypersensitivity to the study drugs.
- Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, locally curative prostate cancer, surgically resected ductal carcinoma in situ, or malignancies diagnosed > 2 years prior to enrollment with no evidence of disease and no treatment within ≤ 2 years before randomization.
- Any other condition that, in the investigator's judgment, may affect the conduct of the study or the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun yat-Sen University Cancer Center
Guangzhou
Meiting Chen, Doctor, 02087341812, chenmt@sysucc.org.cn
Jiajia Huang, Doctor
About this study
Official title: A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates（MBC-EA-II-01）
This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.
Read the detailed description
This is an exploratory study designed to evaluate the efficacy of eribulin in combination with anlotinib in patients with HER2-negative recurrent or metastatic breast cancer who have experienced treatment failure with antibody-drug conjugates (ADCs). The study aims to assess the efficacy and safety of eribulin combined with anlotinib in the treatment of patients with recurrent or metastatic HER2-low breast cancer, and to provide clinical evidence supporting this novel combination regimen.
- Conditions
- HER 2 Negative Breast Cancer
- Being tested
- Eribulin in Combination with Anlotinib
- Keywords
- HER2-Negative Recurrent/Metastatic Breast Cancer, Previously Treated with Antibody-Drug Conjugates, 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.
Eribulin in Combination with AnlotinibDrug
Participants will receive eribulin mesylate administered as a 1-hour intravenous infusion at a dose of 1.4 mg/m² on Days 1 and 8 of each 21-day cycle. Anlotinib will be administered orally at a dose of 8 mg once daily on Days 1 through 14 of each 21-day cycle, followed by a 7-day rest period. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| TNBC and HR positive cohorts | Experimental | Not described Receives: Drug: Eribulin in Combination with Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first.
For patients who have not experienced disease progression or death at the time of analysis, PFS will be censored at the date of the last adequate tumor assessment. If no post-baseline tumor assessment is available, PFS will be censored at the date of first dose.
Disease progression is determined by investigator assessment based on imaging evaluations (e.g., CT, MRI) performed at baseline and at scheduled time points throughout the study.
Unit of Measure: Months
Measured: From date of first dose until the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 24 months
Secondary outcomes (3)
Overall survival
Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
For patients who are alive at the time of analysis, OS will be censored at the last known date the patient was known to be alive. If no post-baseline follow-up information is available, OS will be censored at the date of first dose.
Survival status is collected through scheduled follow-up visits and/or via telephone contact at the end of the study.
Unit of Measure: Months
Measured: From date of first dose until death from any cause, assessed up to 36 months
Safety
Safety and tolerability will be assessed by evaluating the incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs). AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Unit of Measure: Number of participants
Measured: From date of informed consent through 30 days after last dose of study treatment
Quality of Life (QoL)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the breast cancer-specific module.
Unit of Measure: Score on a scale
Measured: From baseline to end of study follow-up, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER 2 Negative 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Jia Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520760
- Sponsor's protocol ID
- MBC-EA-II-01
- Acronym
- MBC-EA
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates（MBC-EA-II-01）
- ClinicalTrials.gov ID
- NCT07520760
- Acronym / sponsor ID
- MBC-EA / MBC-EA-II-01
- Conditions
- HER 2 Negative Breast Cancer
- Keywords
- HER2-Negative Recurrent/Metastatic Breast Cancer, Previously Treated with Antibody-Drug Conjugates, Eribulin, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2035 (estimated)
- First posted
- 9 Apr 2026 (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 is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.
Detailed description
This is an exploratory study designed to evaluate the efficacy of eribulin in combination with anlotinib in patients with HER2-negative recurrent or metastatic breast cancer who have experienced treatment failure with antibody-drug conjugates (ADCs). The study aims to assess the efficacy and safety of eribulin combined with anlotinib in the treatment of patients with recurrent or metastatic HER2-low breast cancer, and to provide clinical evidence supporting this novel combination regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNBC and HR positive cohorts | Experimental | Drug: Eribulin in Combination with Anlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female patients aged ≥ 18 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- HER2-negative status, defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative HER2 gene amplification by fluorescence in situ hybridization (FISH). If multiple specimens have been tested, the most recent test result will be used for determination.
- Prior treatment with anthracycline- or taxane-containing chemotherapy, including in the neoadjuvant or adjuvant setting.
- Intolerance or disease progression following prior treatment with an antibody-drug conjugate (ADC), without the initiation of a new treatment regimen after ADC therapy.
- Received no more than 4 prior lines (including 4 lines) of chemotherapy.
Key exclusion criteria (16 listed)
- Untreated active brain metastases. Patients with asymptomatic central nervous system (CNS) metastases or those with stable brain metastases following radiotherapy are eligible.
- Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, except for patients who have been stable for at least 1 month after treatment and have discontinued corticosteroids for > 2 weeks.
- HER2-positive status, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with positive HER2 gene amplification by fluorescence in situ hybridization (FISH). Patients with a prior HER2-positive status but who are HER2-negative per the most recent pathology test are eligible.
- History of clinically significant cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric diseases.
- Acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive and/or hepatitis B core antibody [HBcAb] positive with hepatitis B virus [HBV] DNA copy number ≥ 1 × 10³ copies/mL or ≥ 200 IU/mL) or acute or chronic active hepatitis C (hepatitis C virus [HCV] antibody positive). Patients with positive HCV antibody but negative HCV RNA are eligible.
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 |
|---|---|---|
| Eribulin in Combination with AnlotinibParticipants will receive eribulin mesylate administered as a 1-hour intravenous infusion at a dose of 1.4 mg/m² on Days 1 and 8 of each 21-day cycle. Anlotinib will be administered orally at a dose of 8 mg once daily on Days 1 through 14 of each 21-day cycle, followed by a 7-day rest period. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. | Drug | TNBC and HR positive cohorts |
Primary outcome
Progression free survival
Time frame: From date of first dose until the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 24 months
Progression free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first. For patients who have not experienced disease progression or death at the time of analysis, PFS will be censored at the date of the last adequate tumor assessment. If no post-baseline tumor assessment is available, PFS will be censored at the date of first dose. Disease progression is determined by investigator assessment based on imaging evaluations (e.g., CT, MRI) performed at baseline and at scheduled time points throughout the study. Unit of Measure: Months
3 secondary outcomes
Overall survival
Time frame: From date of first dose until death from any cause, assessed up to 36 months
Safety
Time frame: From date of informed consent through 30 days after last dose of study treatment
Quality of Life (QoL)
Time frame: From baseline to end of study follow-up, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- 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.
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 Eribulin in Combination with Anlotinib in people with HER 2 Negative 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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meiting Chen, Doctor (02087341812, chenmt@sysucc.org.cn), 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 first dose until the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 24 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 9 Apr 2026.