A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).

Fujian Provincial Cancer Hospital

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Drug: Other Chemotherapy Regimen; Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen

Study type: Observational

Funder types: Other

Identifiers

NCT05953909

K2023-079-01

Details and patient eligibility

About

A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen

Full description

Not provided

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 18-70.
2. The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
4. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
5. Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment.
6. Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).

Exclusion criteria

1. Patients previously treated with eribulin.
2. Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
3. Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.

Trial design

120 participants in 3 patient groups

Eribulin-Based Regimen

Description:

Not Applicable since observational study

Treatment:

Drug: Other Chemotherapy Regimen

Drug: Eribulin-Based Regimen

Drug: nab-paclitaxel based regimen

nab-paclitaxel based regimen

Description:

Not Applicable since observational study

Treatment:

Drug: Other Chemotherapy Regimen

Drug: Eribulin-Based Regimen

Drug: nab-paclitaxel based regimen

Other Chemotherapy Regimen

Description:

Not Applicable since observational study

Treatment:

Drug: Other Chemotherapy Regimen

Drug: Eribulin-Based Regimen

Drug: nab-paclitaxel based regimen