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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05546255

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: Eribulin Mesylate Drug: Lobaplatin	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eribulin Combined With Lobaplatin Eribulin 1.4mg/m2 d1 Lobaplatin 25g/m2 d1 / q14d	Drug: Eribulin Mesylate The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 Drug: Lobaplatin The recommended dose of lobaplatin is 25mg/m2 administered intravenously over on Days 1

Arm

Intervention/Treatment

Experimental: Eribulin Combined With Lobaplatin

Eribulin 1.4mg/m2 d1 Lobaplatin 25g/m2 d1 / q14d

Drug: Eribulin Mesylate

The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1

Drug: Lobaplatin

The recommended dose of lobaplatin is 25mg/m2 administered intravenously over on Days 1

Outcome Measures

Primary Outcome Measures

Objective Response Rate [up to 1 year after the last patient enrolled]
ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)

Secondary Outcome Measures

Progression-free survival [up to 1 year after the last patient enrolled]
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
adverse events [approximately 1.5 years]
Incidence and Severity of adverse events, such as hematologic, hepatotoxicity，Incidence of hypertension，Incidence of proteinuria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female aged between 18 and 75
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.
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;
There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Principal Investigator: Peng Yuan, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peng Yuan, Professor, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05546255

Other Study ID Numbers:

NCC-006461

First Posted:

Sep 19, 2022

Last Update Posted:

Sep 19, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Sep 19, 2022