Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: 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 cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• 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.