Clinical trial NCT04624711: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-negative Breast Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 year
Secondary outcomes:
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: 2 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
state: Jiangsu
Study officials:
References: