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

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ClinicalTrials.gov Identifier: NCT05945368
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: Eribulin mesylate injection、Pertuzumab、Trastuzumab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : February 25, 2024
Estimated Study Completion Date : February 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eribulin+Trastuzumab + Pertuzumab
  • 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
  • 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
Other Name: Eribulin+HP


Outcome Measures
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Primary Outcome Measures :
  1. Pathology Complete Response [ Time Frame: 24 to 28 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: At baseline, 12 and 24 weeks ]
    evaluate the safety

  2. Quality of Life（QoL) questionnaire [ Time Frame: At baseline, 12 and 24 weeks ]
    evaluate the quality of life of patients with HER-2 positive early or locally advanced breast cancer treated with eribulin in combination with trastuzumab and partuzumab

  3. Overall response rate (ORR) [ Time Frame: from the first drug administration up to the first occurrence of progression or death (up to 24 months) ]
    The propotion of subjects with CR or PR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945368


Contacts
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Contact: Qiang Liu, Doc 020-81332199 victorlq@hotmail.com
Contact: Yudong Li, Doc 020-81332199 nihao_0105@163.com

Locations
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China, Guangdong
LI YuDong Recruiting
Guanzhou, Guangdong, China
Contact: LI YuDong, Doctor    17875111048    nihao_0105@163.com   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Study Chair: Qiang Liu, Doc Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Liu Qiang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05945368    
Other Study ID Numbers: 2021-KY-138
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Early or locally advanced breast cancer
HER 2-positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents