Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Eribulin mesylate 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. The treatment duration is six cycles (21 days per cycle). Patients were observed for at least 6 months but no longer than 18 months. |
Drug: Eribulin Mesylate
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.
|
| Experimental: Eribulin mesylate combined with Anlotinib 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. The treatment duration is six cycles (21 days per cycle). Anlotinib dosage is 12mg per day for consecutive 14 days, and then stop 7 days (21 days per cycle). Patients receive Anlotinib untill progression. Patients were observed for at least 6 months but no longer than 18 months. |
Drug: Eribulin Mesylate
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.
Drug: Anlotinib
12 mg Anlotinib is administered for continuous 14 days and then stop 7 days for a treatment cycle. Patients received Anlotinib untill disease progression.
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [From date of randomization until the date at the end of the second treatment cycle (42 days).]
The total rate of CR+PR after the completion of two cycles of treatment.
- Progression-Free Survival [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.]
The survival time from the date of recruitment to the date of the first documented progression or date of death.
- Adverse Events [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old, voluntary consent and signed written informed consent.
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ECOG 0~2.
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Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
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At least one measurable disease lesion before treatment.
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Never receive Eribulin Mesylate treatment before recruitment.
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Anticipated survival time is longer than three months.
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Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
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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.
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There are traceable medical records during treatment.
Exclusion Criteria:
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Pregnant or lactating women.
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Active infection requiring systemic treatment。
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HIV positive
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Suffering from or suspected of suffering from central nervous system diseases.
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Serious heart disease.
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Patients with brain or meningeal metastasis。
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Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen。
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The investigator considered that the patient was not suitable for in this study, with any other situation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunan Cancer Hospital | Changsha | Hunan | China | 410006 |
Sponsors and Collaborators
- Hunan Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YYS-20200305