NCT07520760 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
| NCT ID | NCT07520760 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | HER 2 Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2026-04-01 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 followi
Frequently Asked Questions
Who can join the NCT07520760 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HER 2 Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07520760 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07520760 currently recruiting?
Yes, NCT07520760 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sun Yat-sen University to inquire about joining.
Where is the NCT07520760 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07520760 clinical trial?
NCT07520760 is sponsored by Sun Yat-sen University. The trial plans to enroll 52 participants.
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