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

NCT05945368 | Unknown Phase 2

• 1 other identifier: 2021-KY-138
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Breast Cancer

Keywords

Early or locally advanced breast cancer; HER 2-positive

Outcome Measures

Primary Outcomes (1)

• Pathology Complete Response

  Pathology Complete Response (pCR) was evaluated in pathology complete response (pathology Complete Response) of Eribulin combined with trastuzumab and pertuzumab in neoadjuvant therapy for early or locally advanced breast cancer with positive HER-2.

  24 to 28 weeks

Secondary Outcomes (3)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  At baseline, 12 and 24 weeks

• Quality of Life（QoL) questionnaire

  At baseline, 12 and 24 weeks

• Overall response rate (ORR)

  from the first drug administration up to the first occurrence of progression or death (up to 24 months)

Study Arms (1)

Eribulin+Trastuzumab + Pertuzumab

EXPERIMENTAL

* Eribulin mesylate, 1.4 mg/m², days 1 and 8; * trastuzumab, 8 mg/kg loading dose in cycle 1 and 6 mg/kg thereafter on day 1; * pertuzumab with a loading dose of 840 mg in cycle 1 and 420 mg in subsequent cycles on day 1; 21 days in a cycle of 4 cycles

Drug: Eribulin mesylate injection、Pertuzumab、Trastuzumab

Interventions

Eribulin mesylate injection、Pertuzumab、Trastuzumab DRUG

* 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

Also known as: Eribulin+HP

Eribulin+Trastuzumab + Pertuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

LI YuDong

Guanzhou, Guangdong, China

RECRUITING

Study Officials

• Qiang Liu, Doc

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

  STUDY CHAIR

Central Study Contacts

Qiang Liu, Doc

CONTACT

020-81332199; victorlq@hotmail.com

Yudong Li, Doc

CONTACT

020-81332199; nihao_0105@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: July 14, 2023
• Study Start: February 25, 2022
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

CN (1)