Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

Phase II Clinical Study of Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546255
• Other study ID #: NCC-006461
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, doctor
• Phone: 18612621749
• Email: sunlight_1985[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of eribulin combined with lobaplatin in the treatment of recurrent or metastatic triple-negative breast cancer

Description:

This study is designed to be a prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with recurrent or metastatic triple-negative breast cancer who received the therapy of eribulin combined with lobaplatin from July 1, 2020 to December 31, 2022. It is expected to enroll 40 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female aged between 18 and 75

2. Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER < 10% positive and PR < 10% positive.

3. Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;

4. There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:

1. The number of previous treatment lines (including postoperative adjuvant therapy) <2 lines

2. symptomatic central system metastases. Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).

3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Eribulin Mesylate
The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1
• Lobaplatin
The recommended dose of lobaplatin is 25mg/m2 administered intravenously over on Days 1

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)	up to 1 year after the last patient enrolled
Secondary	Progression-free survival	PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause	up to 1 year after the last patient enrolled
Secondary	adverse events	Incidence and Severity of adverse events, such as hematologic, hepatotoxicity,Incidence of hypertension,Incidence of proteinuria	approximately 1.5 years