Status:
COMPLETED
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
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 hypothesi...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05206656
Start Date
October 9 2020
End Date
July 20 2022
Last Update
November 23 2022
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410006