Breast CancerERI-Based-01NCT05953909
A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).
An observational study of Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Eribulin-Based Regimen, nab-paclitaxel based regimen and Other Chemotherapy Regimen
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Aug 2023
- Phase
- Observational
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The pathologic diagnosis is unresectable recurrent or metastatic triple-negative Chinese Breast cancer patients.
Who may be able to join
- Women aged 18-70.
- The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
- Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment.
- Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).
Who cannot join
- Patients previously treated with eribulin.
- Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
- Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen: A Single-Center Retrospective Study
A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen
Read the detailed description
Not provided
- Conditions
- Breast Cancer
- Being tested
- Eribulin-Based Regimen, nab-paclitaxel based regimen, Other Chemotherapy Regimen
- 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-Based RegimenDrug
Also called Not Applicable since observational study
Eribulin Mesylate will be administered as a 1.4 mg/m^2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
nab-paclitaxel based regimenDrug
Also called Not Applicable since observational study
nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles.
Other Chemotherapy RegimenDrug
Also called Not Applicable since observational study
TX：Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m2 D1 Q3W)+Capecitabine 850-950mg/ m^2, BID D1-14, Q3W.
GP:Gemcitabine 800-1000mg/ m^2, D1,8 Q3W+Cisplatin 75mg/m^2, D1-3, Q3W. AT:Epirubicin 75mg/ m 2, D1, Q3W+Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m^2 D1 Q3W)
T:Docetaxel 75mg/ m ², D1 Q3W (or paclitaxel 80mg/ m ² QW)
| Study group | Role | What they receive |
|---|---|---|
| Eribulin-Based Regimen | Not Applicable since observational study Receives: Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen | |
| nab-paclitaxel based regimen | Not Applicable since observational study Receives: Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen | |
| Other Chemotherapy Regimen | Not Applicable since observational study Receives: Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free surviva (PFS)
The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.
Measured: up to 24 months
Overall survival (OS)
The time interval from the date of randomization to death due to any cause.
Measured: up to 24 months
Secondary outcomes (3)
Overall response rate (ORR)
According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients
Measured: 12 months
Disease Control Rate (DCR)
According to recist1.1 standard, the proportion of patients whose best remission was CR, PR or SD accounted for the total number of evaluable patients.
Measured: 12 months
Incidence of adverse events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- weiwei Huang, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953909
- Sponsor's protocol ID
- K2023-079-01
- Acronym
- ERI-Based-01
- Status last verified
- Jul 2023
- First submitted
- 17 May 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT05953909
- Acronym / sponsor ID
- ERI-Based-01 / K2023-079-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 20 Jul 2023 (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.
A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen
Detailed description
Not provided
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eribulin-Based Regimen | – | Drug: Eribulin-Based Regimen, Drug: nab-paclitaxel based regimen, Drug: Other Chemotherapy RegimenNot Applicable since observational study |
| nab-paclitaxel based regimen | – | Drug: Eribulin-Based Regimen, Drug: nab-paclitaxel based regimen, Drug: Other Chemotherapy RegimenNot Applicable since observational study |
| Other Chemotherapy Regimen | – | Drug: Eribulin-Based Regimen, Drug: nab-paclitaxel based regimen, Drug: Other Chemotherapy RegimenNot Applicable since observational study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The pathologic diagnosis is unresectable recurrent or metastatic triple-negative Chinese Breast cancer patients.
Key inclusion criteria (6 listed)
- Women aged 18-70.
- The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
- Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment.
Key exclusion criteria (3 listed)
- Patients previously treated with eribulin.
- Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
- Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.
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-Based RegimenAlso: Not Applicable since observational studyEribulin Mesylate will be administered as a 1.4 mg/m^2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment. | Drug | Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen |
| nab-paclitaxel based regimenAlso: Not Applicable since observational studynab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles. | Drug | Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen |
| Other Chemotherapy RegimenAlso: Not Applicable since observational studyTX：Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m2 D1 Q3W)+Capecitabine 850-950mg/ m^2, BID D1-14, Q3W. GP:Gemcitabine 800-1000mg/ m^2, D1,8 Q3W+Cisplatin 75mg/m^2, D1-3, Q3W. AT:Epirubicin 75mg/ m 2, D1, Q3W+Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m^2 D1 Q3W) T:Docetaxel 75mg/ m ², D1 Q3W (or paclitaxel 80mg/ m ² QW) | Drug | Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen |
Primary outcome
Progression free surviva (PFS)
Time frame: up to 24 months
The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.
Overall survival (OS)
Time frame: up to 24 months
The time interval from the date of randomization to death due to any cause.
3 secondary outcomes
Overall response rate (ORR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
weiwei Huang principal investigator
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fujian Cancer Hospital 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 6 inclusion and 3 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 20 Jul 2023. 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.
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?
Progression free surviva (PFS) (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 20 Jul 2023.