Back to resultsEribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer
Primary Purpose
HER2-negative Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Eribulin Mesylate
Anlotinib hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for HER2-negative Breast Cancer
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:
- 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).
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.
Sites / Locations
- Jiangsu Provincial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eribulin Mesylate Combined With Anlotinib
Arm Description
Patients receive eribulin mesylate plus anlotinib.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Full Information
NCT ID
NCT04624711
First Posted
November 5, 2020
Last Updated
May 19, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04624711
Brief Title
Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eribulin Mesylate Combined With Anlotinib
Arm Type
Experimental
Arm Description
Patients receive eribulin mesylate plus anlotinib.
Intervention Type
Drug
Intervention Name(s)
Eribulin Mesylate
Other Intervention Name(s)
Halaven
Intervention Description
Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride
Other Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
The Number of Participants Who Experienced Adverse Events (AE)
Description
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Time Frame
2 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongmei Yin
Phone
13951842727
Email
ymyin@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Li
Phone
13851603656
Email
real.lw@163.com
Facility Information:
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhai Tang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer
We'll reach out to this number within 24 hrs