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）

Plain English Summary

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 is a Phase 2 clinical trial sponsored by Sun Yat-sen University studying HER 2 Negative Breast Cancer. This trial tests a new combination of eribulin and anlotinib. It is for women with HER2-negative advanced breast cancer that has not responded to previous treatments, including antibody-drug conjugates. Participants will receive the study drugs intravenously and orally, with cycles of treatment and rest. There are no standard treatment alternatives for patients in this situation. The trial aims to enroll 52 participants.

Official 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. 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 or older with HER2-negative breast cancer that has spread or cannot be removed by surgery. Patients must have previously received chemotherapy and antibody-drug conjugates, and their cancer has progressed. You cannot join if you have untreated brain metastases, certain other medical conditions, or are pregnant or breastfeeding. This trial is studying HER 2 Negative Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Progression-free survival means the trial will measure how long patients live without their cancer getting worse, which is a key indicator of how well the new drug combination is working. The specific primary outcome measures are: Progression free survival (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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical unmet need for patients with advanced HER2-negative breast cancer who have exhausted standard treatment options, offering a potential new therapeutic strategy. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets HER 2 Negative Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a specific patient population with limited options, indicating a potential market for novel therapies in advanced breast cancer, with an estimated approval probability dependent on Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs, how they are given, and potential side effects. Participation involves regular clinic visits for drug administration, monitoring, and tests. You will need to use effective contraception if you are of childbearing potential. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 52 participants

Interventions

• DRUG: Eribulin in Combination with Anlotinib — 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.

Primary Outcomes

• Progression free survival (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

• Overall survival (From date of first dose until death from any cause, assessed up to 36 months)
• Safety (From date of informed consent through 30 days after last dose of study treatment)
• Quality of Life (QoL) (From baseline to end of study follow-up, assessed up to 24 months)

Full Eligibility Criteria

Inclusion Criteria:

1. Female patients aged ≥ 18 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
2. 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.
3. Prior treatment with anthracycline- or taxane-containing chemotherapy, including in the neoadjuvant or adjuvant setting.
4. Intolerance or disease progression following prior treatment with an antibody-drug conjugate (ADC), without the initiation of a new treatment regimen after ADC therapy.
5. Received no more than 4 prior lines (including 4 lines) of chemotherapy.
6. At least one measurable lesion per RECIST v1.1.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
8. Life expectancy ≥ 12 weeks.
9. 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).
10. 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.
11. Willing and able to provide written informed consent, with good compliance and willingness to complete scheduled follow-up.

Exclusion Criteria:

1. Untreated active brain metastases. Patients with asymptomatic central nervous system (CNS) metastases or those with stable brain metastases following radiotherapy are eligible.
2. 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.
3. 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.
4. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric diseases.
5. 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.
6. 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.
7. Known inherited or acquired bleeding tendencies (e.g., hemophilia, coagulation disorders, etc.).
8. 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.
9. Any severe underlying disease, comorbidity, or active infection.
10. Concurrent receipt of other anti-tumor therapy.
11. History of epilepsy or conditions predisposing to seizure.
12. Pregnant or breastfeeding women.
13. Poor compliance or inability to complete scheduled follow-up.
14. Known hypersensitivity to the study drugs.
15. 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.
16. Any other condition that, in the investigator's judgment, may affect the conduct of the study or the interpretation of study results.

Trial Locations

• Sun yat-Sen University Cancer Center, Guangzhou, China

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Metastatic Breast Cancer
• HER2-Negative Breast Cancer
• Recurrent Breast Cancer
• Advanced Breast Cancer
• Chemotherapy
• Antibody-Drug Conjugates
• Oncology
• Cancer Treatment
• Drug Combinations

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