Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer

NCT ID: NCT04624711

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

Breast cancer is the most frequent malignancy in women worldwide. Treatments on metastatic HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.

This study explores the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients. The primary objective is to evaluate the progression free survival (PFS). The secondary objective is to evaluate the safety of the combination of eribulin and anlotinib.

Conditions

HER2-negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eribulin Mesylate Combined With Anlotinib

Patients receive eribulin mesylate plus anlotinib.

Group Type: EXPERIMENTAL

Eribulin Mesylate

Intervention Type: DRUG

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

Anlotinib hydrochloride

Intervention Type: DRUG

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

Interventions

Eribulin Mesylate

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

Intervention Type: DRUG

Anlotinib hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Halaven; Anlotinib

Eligibility Criteria

Inclusion Criteria

• 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:

1. Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L;

2. 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;

3. Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula).

Exclusion Criteria

• 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;
• Researchers believe that it is not suitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongmei Yin

Role: CONTACT

ymyin@njmu.edu.cn

13951842727

Wei Li

Role: CONTACT

real.lw@163.com

13851603656

Facility Contacts

Jinhai Tang

Role: primary

Other Identifiers

EAGER-001

Identifier Type: -

Identifier Source: org_study_id