Combining Eribulin with Targeted Therapy for HER2-Positive Breast Cancer

A Prospective, Single-arm, Phase II Trial of Eribulin in Combination With Trastuzumab and Pertuzumab for Neoadjuvant Therapy HER2-Positive Early or Locally Advanced Breast Cancer

This study is testing if combining the drugs eribulin, trastuzumab, and pertuzumab can help women with early or locally advanced HER2-positive breast cancer before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Drugs / interventions: radiation, trastuzumab, pertuzumab, chemotherapy
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT05945368 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of eribulin mesylate in combination with trastuzumab and pertuzumab as a neoadjuvant therapy for patients with HER2-positive early or locally advanced breast cancer. The study aims to determine the pathology complete response rate (pCR) to this combination treatment. Participants will be newly diagnosed female patients aged 18 to 75 with confirmed HER2-positive breast cancer. The trial will assess both the efficacy and safety of this treatment regimen, with the goal of providing improved options for neoadjuvant chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with newly diagnosed HER2-positive breast cancer.

Not a fit: Patients with hormone receptor-negative breast cancer or those who have previously received treatment for their breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the response rates in patients with HER2-positive breast cancer.

How similar studies have performed: Previous studies have shown promising results with trastuzumab and pertuzumab in neoadjuvant settings, but the combination with eribulin is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Newly treated female patients ≥18 years old and ≤75 years old;
* ECOG score 0-1;
* The pathology of breast cancer meets the following criteria:

Histologically confirmed invasive breast cancer; Tumor stage: Early or locally advanced breast cancer (T1c-T2 and cN1-cN3 or T3-T4/ cN0-cN3, M0)

* Pathologically confirmed HER2-positive breast cancer (definition: +++ or ++ immunohistochemical results with FISH nodes) Page 5 has 24 pages Page 6 has 24 pages Fruit is positive);
* Known hormone receptor status (ER and PgR);
* The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of litterocyte, Platelet enhancer);

  * Blood routine: neutrophil (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L; Red blood Protein (Hb) ≥90 g/L;
  * Blood biochemistry: total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤1.5×ULN; Alkaline phosphatase (ALP) ≤2.5×ULN; urine Nitrogen (BUN) (or urea) and creatinine (Cr) ≤1.5×ULN;
* Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥55%;
* For female patients who are not menopausal or have not been surgically sterilized: arrive after the last dose during treatment and study therapy Within six months, agree to abstain from sex or use an effective contraceptive method.
* Participate in this study voluntarily, sign informed consent, have good compliance and willing to cooperate with follow-up.

Exclusion Criteria:

* Stage IV breast cancer;
* Other specific types of breast cancer;
* Antitumor therapy or radiation therapy for any malignancy within the previous 5 years, excluding cured cervix Subcutaneous carcinoma, basal cell carcinoma or squamous cell carcinoma;
* Also receiving antitumor therapy in other clinical trials;
* Had major non-breast cancer related surgery within 4 weeks prior to randomization, or had not yet undergone such surgery Complete recovery in progress. 6. Serious cardiovascular and cerebrovascular diseases or discomfort, including but not limited to the following diseases:

  * History of heart failure or systolic dysfunction (LVEF \< 50%)
  * High risk of uncontrolled arrhythmia
  * Angina pectoris, acute myocardial infarction
  * Valvular heart disease of clinical significance
  * Poor hypertension control (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Known allergic history of drug components of the program;
* A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation;
* Pregnant and lactating women, fertile women with a positive baseline pregnancy test, or patients in Patients of childbearing age who were unwilling to use effective contraception throughout the trial period;
* The patient has a serious concomitant disease or other comorbiditis that would interfere with planned treatment, or is considered unwell by the investigator In conjunction with any other circumstances involved in the study.

Where this trial is running

Guanzhou, Guangdong

• LI YuDong — Guanzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Qiang Liu, Doc

Conditions: HER2-positive Breast Cancer, Early or locally advanced breast cancer, HER 2-positive