Treatment EfficacyNCT07480694
Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC
An observational study of Treatment Efficacy, run by Fudan University.
Trial summary
This study is a real-world study. we collected patients with advanced HER2-negative breast cancer previously treated with antibody-drug conjugates, and received eribulin mesylate-based therapy post-ADC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Efficacy
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Feb 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced HER2-negative breast cancer patients previously treated with ADC
Who may be able to join
- At least 18 years old;
- Inoperable locally advanced or metastatic breast cancer;
- Planning to use a single-agent or combination treatment regimen based on eribulin;
- HER2 negative (IHC 0,+, or ++ but ISH negative);
- Previously received ADC treatment at the local advanced or metastatic disease stage;
- Previously received chemotherapy (including ADC) for local advanced or metastatic disease no more than 2 lines, where one treatment line is defined as completing at least one cycle of chemotherapy;
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- Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0-2;
- The investigators have evaluated that the patient's organ and bone marrow functions are suitable for medication use and there are no relevant contraindications;
- The subjects voluntarily join the study and sign the informed consent.
Who cannot join
- HER2-positive tumors
- The hormone receptor status is unknown;
- Patients who have received eribulin treatment before;
- Those who have had other malignant tumors within the past 5 years (excluding the following situations: cured skin basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma; second primary cancer that has been cured and has no recurrence within 5 years; subjects who have clearly identified the origin of the metastatic lesion as being from a certain primary tumor);
- Mental illness or mental disorder, patients with poor compliance and inability to cooperate and describe treatment responses;
- Pregnant or lactating women;
- Other serious or uncontrollable diseases, or other conditions assessed by the researcher as not suitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates
This study is a real-world study. we collected patients with advanced HER2-negative breast cancer previously treated with antibody-drug conjugates, and received eribulin mesylate-based therapy post-ADC. We retrospectively collect the data on previous systemic treatment, and prospectively collect the treatment data of the therapeutic regimens based on eribulin mesylate.
- Conditions
- Treatment Efficacy
- Keywords
- Eribulin Mesylate-based Therapy, Advanced HER2-negative Breast Cancer, ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| advanced HER2-negative breast cancer patients previously treated with ADC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
the period from the start of eribulin mesylate-based therapy treatment until the disease progress or death from any cause, whichever occurred first
Measured: From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment EfficacyStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
- Investigators
- Jian Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480694
- Sponsor's protocol ID
- EVALUATE
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates
- ClinicalTrials.gov ID
- NCT07480694
- Acronym / sponsor ID
- EVALUATE
- Conditions
- Treatment Efficacy
- Keywords
- Eribulin Mesylate-based Therapy, Advanced HER2-negative Breast Cancer, ADC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Mar 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 a real-world study. we collected patients with advanced HER2-negative breast cancer previously treated with antibody-drug conjugates, and received eribulin mesylate-based therapy post-ADC. We retrospectively collect the data on previous systemic treatment, and prospectively collect the treatment data of the therapeutic regimens based on eribulin mesylate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced HER2-negative breast cancer patients previously treated with ADC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced HER2-negative breast cancer patients previously treated with ADC
Key inclusion criteria (9 listed)
- At least 18 years old;
- Inoperable locally advanced or metastatic breast cancer;
- Planning to use a single-agent or combination treatment regimen based on eribulin;
- HER2 negative (IHC 0,+, or ++ but ISH negative);
- Previously received ADC treatment at the local advanced or metastatic disease stage;
Key exclusion criteria (7 listed)
- HER2-positive tumors
- The hormone receptor status is unknown;
- Patients who have received eribulin treatment before;
- Those who have had other malignant tumors within the past 5 years (excluding the following situations: cured skin basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma; second primary cancer that has been cured and has no recurrence within 5 years; subjects who have clearly identified the origin of the metastatic lesion as being from a certain primary tumor);
- Mental illness or mental disorder, patients with poor compliance and inability to cooperate and describe treatment responses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.
the period from the start of eribulin mesylate-based therapy treatment until the disease progress or death from any cause, whichever occurred first
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 18 Mar 2026.
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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.
Jian Zhang principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Efficacy, run by Fudan University.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jian Zhang (64175590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.). 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 18 Mar 2026.