Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer

NCT04624711 | Unknown Phase 2 FDA Drug

• 1 other identifier: EAGER-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients.

Conditions

HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

  2 year

Secondary Outcomes (1)

• The Number of Participants Who Experienced Adverse Events (AE)

  2 year

Study Arms (1)

Eribulin Mesylate Combined With Anlotinib

EXPERIMENTAL

Patients receive eribulin mesylate plus anlotinib.

Drug: Eribulin Mesylate; Drug: Anlotinib hydrochloride

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.

Also known as: Halaven

Eribulin Mesylate Combined With Anlotinib

Anlotinib hydrochloride DRUG

Anlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle.

Also known as: Anlotinib

Eribulin Mesylate Combined With Anlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteers and signs an informed consent form;
• Age ≥18 years old, female;
• The patient was diagnosed as HER2 negative breast cancer by histopathology ( HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is at least 1 measurable lesion of metastasis according to RECIST 1.1;
• All patients have previously underwent chemotherapy containing anthracyclines and taxanes, and received ≥1 line chemotherapy for metastatic breast cancer;
• Patients with hormone receptor positive (ER positive (IHC ER positive percentage ≥1%), PR positive (IHC PR positive percentage ≥1%)) have underwent ≥1 line endocrine therapy;
• Physical condition ECOG PS: 0-1;
• Laboratory tests meet the following criteria:
• Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L;
• Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper limit of normal (ULN) \*1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5;
• Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula).

You may not qualify if:

• Previous breast cancer history (except for ipsilateral DCIS that only received local treatment ≥5 years ago), malignant tumors of other histological origins (except for non-melanoma skin cancer or cervical carcinoma in situ) unless the patient's tumor had been completely alleviated and had not received treatment for at least 5 years before the enrollment date;
• Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed;
• Embolization and bleeding occurred within 4 weeks before enrollment;
• Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure\>NYHA II, severe heart rhythm Abnormalities and pericardial effusions;
• Severe infection requires intravenous antibiotic, antifungal or antiviral treatment;
• Other clinical trials of drugs were used in the first four weeks of the first medication;
• Subjects with treatment history of eribulin or anti-angiogenesis drugs;
• Suffering from mental illness, poor compliance;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

eribulin; anlotinib

Central Study Contacts

Yongmei Yin

CONTACT

13951842727; ymyin@njmu.edu.cn

Wei Li

CONTACT

13851603656; real.lw@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: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)