HER2-negative Breast CancerPhase 2NCT05263882
Gemcitabine Combined With Eribulin Regimen in the Treatment of Second-line Above Recurrent HER2-negative Breast Cancer
A Phase 2 study testing Gemcitabine combined with eribulin in people with HER2-negative Breast Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This study intends to conduct a single-arm, open-label Phase II multicenter clinical study of gemcitabine combined with eribulin regimen in the treatment of second-line above recurrent HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-negative Breast Cancer
- What is being tested?
- Gemcitabine combined with eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Sep 2024
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed histological examination confirmed breast cancer patients with locally advanced or metastatic HER2-negative (expression lack of human epidermal growth factor 2 (HER2) confirmed by central laboratory examination) and unsuitable for surgical treatment;
- Received first-line or above systemic therapy in the past, with disease progression after the last treatment, and have used anthracyclines and/or taxanes, and currently there is no standard treatment regimen;
- Must have at least one evaluable lesion according to RRECIST version 1.1 criteria (the longest diameter on spiral CT is at least 10mm, and the longest diameter on ordinary CT is at least 20mm);
- Female, 18 years old ≤ aged ≤75 years old;
- ECOG PS 0~2 points;
- Expected survival period ≥ 3 months;
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- Sufficient blood function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥ 80×109/L and hemoglobin ≥ 8g/dL;
- Sufficient liver function: total bilirubin ≤ 1.5 times the upper limit of normal (ULN); AST and ALT ≤ 2.5 times the upper limit of normal (ULN); alkaline phosphatase ≤ 5 times the upper limit of normal (ULN);
- Sufficient renal function: serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min;
- The electrocardiogram is basically normal;
- Women with an intact uterus must have a negative pregnancy test result within 28 days prior to enrollment in the study (unless it has been 24 months of amenorrhea). If the pregnancy test is more than 7 days from the first dose, a urine pregnancy test is required for verification (within 7 days before the first dose);
- Have not received radiotherapy, chemotherapy, targeted therapy and other treatments within 4 weeks before enrollment;
- Signed the informed consent.
- Exclusion criteria (Subjects can not enter the study if they meet any of the following conditions)
- Pregnant, lactating women, or female patients who are fertile but not taking contraceptive measures;
- Existing severe acute infection that has not been controlled; or purulent and chronic infection with persistent wound healing;
- Patients with original serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and resistant hypertension;
- Those with bleeding tendency;
- Individual with mental disorders/individual who cannot obtain informed consent;
- Patients who use drugs and alcohol for a long time, which affects the evaluation of the test results;
- Other conditions in which the investigator believes that the patient should not participate in this trial.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase Ⅱ Single-arm, Open-labelled, Multi-center, Clinical Trial of Gemcitabine Combined With Eribulin for the Treatment of Second-line and Above in Patients With Recurrent HER2 Negative Breast Cancer
This study intends to conduct a single-arm, open-label Phase II multicenter clinical study of gemcitabine combined with eribulin regimen in the treatment of second-line above recurrent HER2-negative breast cancer. Patients with recurrent HER2-negative breast cancer were recruited, and the efficacy and clinical significance of gemcitabine combined with eribulin regimen in the treatment of recurrent HER2-negative breast cancer second-line above was studied.
- Conditions
- HER2-negative Breast Cancer
- Being tested
- Gemcitabine combined with eribulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine combined with eribulinDrug
- Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle.
- Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle.
- The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | * Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle.
* Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle.
* The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur. Receives: Drug: Gemcitabine combined with eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recent objective efficacy evaluation
In this clinical study, the efficacy evaluation method of RECIST version 1.1 was adopted, and the objective efficacy changes were evaluated according to the changes in the sum of the longest diameters of each target lesion.
Measured: 2 years
Secondary outcomes (1)
Disease progression-free survival
progression-free survival is defined as the time from the date of randomization to any objectively documented tumor progression or patient death. In the event of a patient lost to follow-up, unexplained death or other anti-tumor therapy, the Disease progression-free survival was calculated up to this point.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peijian Peng, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263882
- Sponsor's protocol ID
- ZDWY.XBZL.002
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Single-arm, Open-labelled, Multi-center, Clinical Trial of Gemcitabine Combined With Eribulin for the Treatment of Second-line and Above in Patients With Recurrent HER2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05263882
- Acronym / sponsor ID
- ZDWY.XBZL.002
- Conditions
- HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Mar 2022 (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 intends to conduct a single-arm, open-label Phase II multicenter clinical study of gemcitabine combined with eribulin regimen in the treatment of second-line above recurrent HER2-negative breast cancer. Patients with recurrent HER2-negative breast cancer were recruited, and the efficacy and clinical significance of gemcitabine combined with eribulin regimen in the treatment of recurrent HER2-negative breast cancer second-line above was studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Drug: Gemcitabine combined with eribulin* Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle. * Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle. * The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically diagnosed histological examination confirmed breast cancer patients with locally advanced or metastatic HER2-negative (expression lack of human epidermal growth factor 2 (HER2) confirmed by central laboratory examination) and unsuitable for surgical treatment;
- Received first-line or above systemic therapy in the past, with disease progression after the last treatment, and have used anthracyclines and/or taxanes, and currently there is no standard treatment regimen;
- Must have at least one evaluable lesion according to RRECIST version 1.1 criteria (the longest diameter on spiral CT is at least 10mm, and the longest diameter on ordinary CT is at least 20mm);
- Female, 18 years old ≤ aged ≤75 years old;
- ECOG PS 0~2 points;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gemcitabine combined with eribulin* Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle. * Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle. * The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur. | Drug | single arm |
Primary outcome
Recent objective efficacy evaluation
Time frame: 2 years
In this clinical study, the efficacy evaluation method of RECIST version 1.1 was adopted, and the objective efficacy changes were evaluated according to the changes in the sum of the longest diameters of each target lesion.
1 secondary outcome
Disease progression-free survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine combined with eribulin in people with HER2-negative Breast Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 21 inclusion and 0 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 3 Mar 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Peijian Peng (0756-2528888, pengpjian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent objective efficacy evaluation (time frame: 2 years). 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 3 Mar 2022.