Metastatic Breast CancerPhase 2NCT05206656
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
A Phase 2 study testing Eribulin Mesylate and Anlotinib in people with Metastatic Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Eribulin Mesylate and Anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 20 Jul 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, voluntary consent and signed written informed consent
- ECOG 0~2
- Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted
- At least one measurable disease lesion before treatment
- Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment
- Anticipated survival time is longer than three months
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- Brain metastases with stable disease or without clinical symptom
- Blood routine test, liver and kidney function test meet the following criteria: PLT > 100g / L, Hb > 9g / L, Neutrophil > 2.0 g/L; AST and ALT < 2.5 upper limit of normal (ULN); Cr < 1.0 ULN; TBIL < 1.5ULN
- Previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for HR-positive/HER2-negative patients, progressed after at least one line of endocrine therapy
- For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment; Men agreed to take appropriate contraceptive measures during the study treatment and at least half a year after the end of the treatment.
Who cannot join
- Pregnant or lactating women
- Active infection requiring systemic treatment
- HIV positive
- Suffering from or suspected of suffering from central neuromuscular system diseases
- Serious heart disease; uncontrollable hypertension; history of heavy hemorrhea；recent operation within three months
- The investigator considered that the patient was not suitable for in this study, with any other situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study
Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic breast cancer
Read the detailed description
The aim of the double-arm, open-label, phase II clinical trial is to assess efficacy and safety of Eribulin or Eribulin combined with Anlotinib in metastatic breast cancers. The investigator hypothesize that both Eribulin and Eribulin combined with Anlotinib may be an effective alternative treatment for metastatic breast cancers. In addition, Eribulin combined with Anlotinib might be able to improve the treatment response and progression-free survival.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Eribulin Mesylate, Anlotinib
- 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 MesylateDrug
Eribulin mesylate injection is performed on Day 1 and Day 8 of each treatment cycle (21 days per cycle). Patients were treated for six cycles, except disease progression (PD) or treatment stop for other reasons, such as severe adverse effects.
AnlotinibDrug
12 mg Anlotinib is administered for continuous 14 days in 21 day cycles. Patients received Anlotinib untill disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin mesylate | Placebo comparator | Metastatic breast cancer patients receive eribulin mesylate injection alone. The dosage is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Patients receive Eribulin untill progression.
Patients were observed for at least 6 months but no longer than 18 months. Receives: Drug: Eribulin Mesylate |
| Eribulin mesylate combined with Anlotinib | Experimental | Metastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle.
Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression.
Patients were observed for at least 6 months but no longer than 18 months. Receives: Drug: Eribulin Mesylate; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The time from the date of recruitment to the date of first documented progression or date of death from any cause
Measured: through study completion, up to 6 months.
Secondary outcomes (5)
Disease Control Rate (DCR)
The total rate of CR+PR+SD after the completion of two cycles of treatment
Measured: At the end of Cycle 2 (42 days).
Overall survival (OS)
The survival time from the date of recruitment to the date of death from any cause
Measured: through study completion, an average of 2 year
Objective response rate (ORR)
The total rate of CR+PR after the completion of two cycles of treatment
Measured: At the end of Cycle 2 (42 days).
Adverse Events
All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
Measured: through study completion, up to 6 months.
Patient Report Outcome (PRO)
HRQoL was assessed using FACT-B at baseline and months 1,3 ,6, 9 and 12 (end of treatment). Questionnaires were administered in the local language and completed independently by patients using paper document during visits to their reference center and before any clinical procedures.
Measured: through study completion, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start9 Oct 2020
- Primary completion30 Apr 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206656
- Sponsor's protocol ID
- YYS-20200305
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2021
- Last updated
- 23 Nov 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05206656
- Acronym / sponsor ID
- YYS-20200305
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 25 Jan 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.
Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic breast cancer
Detailed description
The aim of the double-arm, open-label, phase II clinical trial is to assess efficacy and safety of Eribulin or Eribulin combined with Anlotinib in metastatic breast cancers. The investigator hypothesize that both Eribulin and Eribulin combined with Anlotinib may be an effective alternative treatment for metastatic breast cancers. In addition, Eribulin combined with Anlotinib might be able to improve the treatment response and progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eribulin mesylate | Placebo comparator | Drug: Eribulin MesylateMetastatic breast cancer patients receive eribulin mesylate injection alone. The dosage is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Patients receive Eribulin untill progression. Patients were observed for at least 6 months but no longer than 18 months. |
| Eribulin mesylate combined with Anlotinib | Experimental | Drug: Eribulin Mesylate, Drug: AnlotinibMetastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression. Patients were observed for at least 6 months but no longer than 18 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old, voluntary consent and signed written informed consent
- ECOG 0~2
- Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted
- At least one measurable disease lesion before treatment
- Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Active infection requiring systemic treatment
- HIV positive
- Suffering from or suspected of suffering from central neuromuscular system diseases
- Serious heart disease; uncontrollable hypertension; history of heavy hemorrhea；recent operation within three months
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 MesylateEribulin mesylate injection is performed on Day 1 and Day 8 of each treatment cycle (21 days per cycle). Patients were treated for six cycles, except disease progression (PD) or treatment stop for other reasons, such as severe adverse effects. | Drug | Eribulin mesylate, Eribulin mesylate combined with Anlotinib |
| Anlotinib12 mg Anlotinib is administered for continuous 14 days in 21 day cycles. Patients received Anlotinib untill disease progression. | Drug | Eribulin mesylate combined with Anlotinib |
Primary outcome
Progression-Free Survival
Time frame: through study completion, up to 6 months.
The time from the date of recruitment to the date of first documented progression or date of death from any cause
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: At the end of Cycle 2 (42 days).
Overall survival (OS)
Time frame: through study completion, an average of 2 year
Objective response rate (ORR)
Time frame: At the end of Cycle 2 (42 days).
Adverse Events
Time frame: through study completion, up to 6 months.
Patient Report Outcome (PRO)
Time frame: through study completion, up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin Mesylate and Anlotinib in people with Metastatic Breast Cancer, run by Hunan 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 23 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Survival (time frame: through study completion, up to 6 months.). 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 23 Nov 2022.