Overview
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Status:
Recruiting
Recruiting
Trial end date:
2022-08-30
2022-08-30
Target enrollment:
0
0
Participant gender:
All
All
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 cancerPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hunan Cancer Hospital
Criteria
Inclusion Criteria:- Age ≥ 18 years old, voluntary consent and signed written informed consent.
- ECOG 0~2.
- Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast
cancer.
- At least one measurable disease lesion before treatment.
- Never receive Eribulin Mesylate treatment before recruitment.
- Anticipated survival time is longer than three months.
- Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
- 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.
- There are traceable medical records during treatment.
Exclusion Criteria:
- Pregnant or lactating women.
- Active infection requiring systemic treatment。
- HIV positive
- Suffering from or suspected of suffering from central nervous system diseases.
- Serious heart disease.
- Patients with brain or meningeal metastasis。
- Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active
treatment, including the use of oxygen。
- The investigator considered that the patient was not suitable for in this study, with
any other situation.