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

NCT05546255 | Unknown Phase 2

• 1 other identifier: NCC-006461
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival

  up to 1 year after the last patient enrolled

• adverse events

  approximately 1.5 years

Study Arms (1)

Eribulin Combined With Lobaplatin

EXPERIMENTAL

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

Drug: Eribulin Mesylate; Drug: Lobaplatin

Interventions

Eribulin Mesylate DRUG

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

Eribulin Combined With Lobaplatin

Lobaplatin DRUG

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

Eribulin Combined With Lobaplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin; lobaplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peng Yuan, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, doctor

CONTACT

18612621749; sunlight_1985@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: June 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)