Breast Cancer MetastaticPhase 3NCT06857305
Efficacy and Safety of Biweekly Regimen of Eribulin Versus a Standard Regimen for the Treatment of Locally Recurrent or Metastatic HER2-negative Breast Cancer: a Multicenter, Randomized, Open-label, Phase III Trial
A Phase 3 study testing Eribulin biweekly regimen and Eribulin standard regimen in people with Breast Cancer Metastatic, run by Ma Fei，MD at 1 site in China.
Trial summary
Eribulin is a soft spongin-like inhibitor of mitotic microtubule dynamics in cells. From the evidence of efficacy, the STUDY 305 and STUDY 301 studies suggest that eribulin improves PFS and OS in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Eribulin biweekly regimen and Eribulin standard regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2023to 13 Jul 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- ECOG 0-2
- Expected survival of not less than 12 weeks
- At least one measurable lesion
- With HER2 negative locally recurrent or metastatic breast cancer
- Metastatic breast cancer advanced stage received ≤3 lines of chemotherapy
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- Previous anthracycline and paclitaxel therapy
- Well organ functional status 1）routine blood test
- ANC≥1.5×109/L；
- PLT≥90×109/L；
- Hb≥90 g/L； 2）blood biochemistry
- TBIL≤1.5×ULN；
- ALT/AST≤2×ULN；patients with liver matastasis ALT/AST≤5×ULN；
- BUN/Cr≤1.5×ULN and creatinine clearance ≥50 mL/min （Cockcroft-Gault） 3）cardiology ultrasound
- LVEF≥50%；
- Signed informed consent, good compliance and willingness to cooperate with follow-up visits
Who cannot join
- With third interstitial fluid that cannot be controlled by drainage or other means
- Symptomatic brain or meningeal metastases
- Patients with only bone or skin as the sole target lesion
- Pre-existing other malignant tumors
- Patients who have used eribulin in the adjuvant and palliative phases of care
- Known history of allergy to components of this regimen; history of immunodeficiency
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- Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period
- Have a concomitant illness that, in the investigator's judgment, seriously jeopardizes the patient's safety, or interferes with the patient's ability to complete the study.
- A clear past history of neurological or psychiatric disorders
- Any other condition for which the investigator believes the patient is not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinses Academy of Medical Sciences
Beijing, B, 100020
About this study
Eribulin is a soft spongin-like inhibitor of mitotic microtubule dynamics in cells. From the evidence of efficacy, the STUDY 305 and STUDY 301 studies suggest that eribulin improves PFS and OS in patients with breast cancer. Eribulin has a good safety profile with a low incidence of patient-perceivable adverse effects, with myelosuppression being the main adverse effect, and neutropenia, anemia, and also fatigue being the most common adverse effects. However, serious neutropenia, may result in delayed dosing, dose reduction or discontinuation in some patients.
In studies of standard regimen therapy with eribulin, grade 3-4 neutropenia occurred in approximately 45% of patients, of which approximately 25% required dose adjustment or discontinuation of therapy, which has become an urgent clinical problem in the treatment of eribulin. Therefore, a modified bi-weekly regimen of eribulin (1.4 mg/m2 intravenously on days 1 and 15 of a 28-day cycle), based on the standard regimen (1.4 mg/m2 intravenously on days 1 and 8 of a 21-day cycle), is expected to improve the safety of eribulin administration without compromising efficacy, in order to minimize dose reductions of the medication and interruptions of therapy, thereby improving patients' quality of life.
There is still a lack of head-to-head studies on the efficacy and safety of the combination of eribulin standard regimen and biweekly regimen in HER2-negative advanced breast cancer, and the treatment data in the Chinese population need to be further explored. The aim of this study is to explore the efficacy and safety of eribulin biweekly regimen compared with the standard regimen in patients with locally recurrent or metastatic HER2-negative breast cancer, and to provide a clinical evidence-based basis for the optimization of eribulin treatment regimen.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Eribulin biweekly regimen, Eribulin standard regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin biweekly regimenDrug
Eribulin biweekly regimen
Eribulin standard regimenDrug
Eribulin standard regimen
| Study group | Role | What they receive |
|---|---|---|
| eribulin biweekly regimen | Experimental | Not described Receives: Drug: Eribulin biweekly regimen |
| eribulin standard regimen | Experimental | Not described Receives: Drug: Eribulin standard regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
Clinical benefit was defined as patients who achieve complete response/partial response or stable disease of over 6 months
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start13 Jul 2023
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ma Fei，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Hongnan Mo, Study chair, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857305
- Sponsor's protocol ID
- NCC4143
- Status last verified
- May 2024
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Biweekly Regimen of Eribulin Versus a Standard Regimen for the Treatment of Locally Recurrent or Metastatic HER2-negative Breast Cancer: a Multicenter, Randomized, Open-label, Phase III Trial
- ClinicalTrials.gov ID
- NCT06857305
- Acronym / sponsor ID
- NCC4143
- Conditions
- Breast Cancer Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Ma Fei，MDUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 4 Mar 2025 (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.
Eribulin is a soft spongin-like inhibitor of mitotic microtubule dynamics in cells. From the evidence of efficacy, the STUDY 305 and STUDY 301 studies suggest that eribulin improves PFS and OS in patients with breast cancer. Eribulin has a good safety profile with a low incidence of patient-perceivable adverse effects, with myelosuppression being the main adverse effect, and neutropenia, anemia, and also fatigue being the most common adverse effects. However, serious neutropenia, may result in delayed dosing, dose reduction or discontinuation in some patients.
In studies of standard regimen therapy with eribulin, grade 3-4 neutropenia occurred in approximately 45% of patients, of which approximately 25% required dose adjustment or discontinuation of therapy, which has become an urgent clinical problem in the treatment of eribulin. Therefore, a modified bi-weekly regimen of eribulin (1.4 mg/m2 intravenously on days 1 and 15 of a 28-day cycle), based on the standard regimen (1.4 mg/m2 intravenously on days 1 and 8 of a 21-day cycle), is expected to improve the safety of eribulin administration without compromising efficacy, in order to minimize dose reductions of the medication and interruptions of therapy, thereby improving patients' quality of life.
There is still a lack of head-to-head studies on the efficacy and safety of the combination of eribulin standard regimen and biweekly regimen in HER2-negative advanced breast cancer, and the treatment data in the Chinese population need to be further explored. The aim of this study is to explore the efficacy and safety of eribulin biweekly regimen compared with the standard regimen in patients with locally recurrent or metastatic HER2-negative breast cancer, and to provide a clinical evidence-based basis for the optimization of eribulin treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eribulin biweekly regimen | Experimental | Drug: Eribulin biweekly regimen |
| eribulin standard regimen | Experimental | Drug: Eribulin standard regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Over 18 years old
- ECOG 0-2
- Expected survival of not less than 12 weeks
- At least one measurable lesion
- With HER2 negative locally recurrent or metastatic breast cancer
Key exclusion criteria (10 listed)
- With third interstitial fluid that cannot be controlled by drainage or other means
- Symptomatic brain or meningeal metastases
- Patients with only bone or skin as the sole target lesion
- Pre-existing other malignant tumors
- Patients who have used eribulin in the adjuvant and palliative phases of care
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 biweekly regimenEribulin biweekly regimen | Drug | eribulin biweekly regimen |
| Eribulin standard regimenEribulin standard regimen | Drug | eribulin standard regimen |
Primary outcome
Clinical benefit rate
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical benefit was defined as patients who achieve complete response/partial response or stable disease of over 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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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.
Hongnan Mo study chair
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eribulin biweekly regimen and Eribulin standard regimen in people with Breast Cancer Metastatic, run by Ma Fei，MD 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 16 inclusion and 10 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 4 Mar 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (time frame: From enrollment to the end of treatment at 8 weeks). 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 4 Mar 2025.