A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC

Trial Title: A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC

NCT ID: NCT05945368

Condition: HER2-positive Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Pertuzumab

Conditions: Keywords:
Early or locally advanced breast cancer
HER 2-positive

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Eribulin mesylate injection、Pertuzumab、Trastuzumab
Description: - Eribulin mesylate, 1.4 mg /m², day 1 and day 8; - Trastuzumab, 8 mg/kg load dose in the first cycle and 6 mg/kg in each subsequent cycle on day 1; - Pertuzumab, 840 mg load dose in the first cycle and 420 mg in each subsequent cycle on day 1; There are four cycles in 21 days
Arm group label: Eribulin+Trastuzumab + Pertuzumab

Other name: Eribulin+HP

Summary: To evaluate the pathology complete response rate (pathology Complete Response, pCR) of eribulin combined with trastuzumab + pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer.

Detailed description: Breast cancer with positive HER-2 is sensitive to chemotherapy and targeted therapy, and double-target regimen containing trastuzumab and pertuzumab is the preferred regimen no matter in neoadjuvant, adjuvant or advanced first-line stage. A series of clinical studies have established the strong position of trastuzumab + pertuzumab in the neoadjuvant therapy of HER2-positive breast cancer, but it is still unclear which chemotherapy drugs have the best efficacy when combined with them. Eribulin mesylate is a potent microtubule inhibitor. It is used as a single agent for the treatment of locally relapsed or metastatic breast cancer that has been treated with at least two chemotherapy regimens in the past, because of its good therapeutic effect and small toxic side effects The role of advanced breast cancer treatment is increasingly prominent. Therefore, the investigators plan to conduct clinical studies to evaluate the efficacy and safety of Eribulin combined with trastuzumab and pertuzumab in neoadjuvant therapy for HER-2 positive breast cancer, so as to provide better treatment options for neoadjuvant chemotherapy for HER-2 positive breast cancer. The investigators expect that Erribulin combined with trastuzumab and pertuzumab can achieve comparable results. If the pCR rate in this study reaches 40%, follow-up randomized controlled studies will be considered.

Criteria for 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.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: LI YuDong

Address:
City: Guanzhou
Country: China

Status: Recruiting

Contact:
Last name: LI YuDong, Doctor

Phone: 17875111048
Email: nihao_0105@163.com

Start date: February 25, 2022

Completion date: February 25, 2025

Lead sponsor:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05945368