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

NCT05206656 | Completed Phase 2

• 1 other identifier: YYS-20200305
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The time from the date of recruitment to the date of first documented progression or date of death from any cause

  through study completion, up to 6 months.

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  At the end of Cycle 2 (42 days).

• Overall survival (OS)

  through study completion, an average of 2 year

• Objective response rate (ORR)

  At the end of Cycle 2 (42 days).

• Adverse Events

  through study completion, up to 6 months.

• Patient Report Outcome (PRO)

  through study completion, up to 6 months.

Study Arms (2)

Eribulin mesylate

PLACEBO COMPARATOR

Metastatic breast cancer patients receive eribulin mesylate injection alone. The dosage is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Patients receive Eribulin untill progression. Patients were observed for at least 6 months but no longer than 18 months.

Drug: Eribulin Mesylate

Eribulin mesylate combined with Anlotinib

EXPERIMENTAL

Metastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression. Patients were observed for at least 6 months but no longer than 18 months.

Drug: Eribulin Mesylate; Drug: Anlotinib

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate injection is performed on Day 1 and Day 8 of each treatment cycle (21 days per cycle). Patients were treated for six cycles, except disease progression (PD) or treatment stop for other reasons, such as severe adverse effects.

Eribulin mesylate; Eribulin mesylate combined with Anlotinib

Anlotinib DRUG

12 mg Anlotinib is administered for continuous 14 days in 21 day cycles. Patients received Anlotinib untill disease progression.

Eribulin mesylate combined with Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, voluntary consent and signed written informed consent
• ECOG 0\~2
• Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted
• At least one measurable disease lesion before treatment
• Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment
• Anticipated survival time is longer than three months
• Brain metastases with stable disease or without clinical symptom
• Blood routine test, liver and kidney function test meet the following criteria: PLT \> 100g / L, Hb \> 9g / L, Neutrophil \> 2.0 g/L; AST and ALT \< 2.5 upper limit of normal (ULN); Cr \< 1.0 ULN; TBIL \< 1.5ULN
• Previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for HR-positive/HER2-negative patients, progressed after at least one line of endocrine therapy
• 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.

You may not qualify if:

• Pregnant or lactating women
• Active infection requiring systemic treatment
• HIV positive
• Suffering from or suspected of suffering from central neuromuscular system diseases
• Serious heart disease; uncontrollable hypertension; history of heavy hemorrhea；recent operation within three months
• The investigator considered that the patient was not suitable for in this study, with any other situation.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; anlotinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 25, 2022
• Study Start: October 9, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 20, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)