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

Primary Purpose

HER2-positive Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Eribulin mesylate injection、Pertuzumab、Trastuzumab
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring Early or locally advanced breast cancer, HER 2-positive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • LI YuDongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eribulin+Trastuzumab + Pertuzumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
evaluate the safety
Quality of Life(QoL) questionnaire
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
Overall response rate (ORR)
The propotion of subjects with CR or PR.

Full Information

First Posted
May 28, 2023
Last Updated
July 13, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05945368
Brief Title
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
February 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
Early or locally advanced breast cancer, HER 2-positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eribulin+Trastuzumab + Pertuzumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Eribulin mesylate injection、Pertuzumab、Trastuzumab
Other Intervention Name(s)
Eribulin+HP
Intervention 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
Primary Outcome Measure Information:
Title
Pathology Complete Response
Description
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.
Time Frame
24 to 28 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Description
evaluate the safety
Time Frame
At baseline, 12 and 24 weeks
Title
Quality of Life(QoL) questionnaire
Description
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
Time Frame
At baseline, 12 and 24 weeks
Title
Overall response rate (ORR)
Description
The propotion of subjects with CR or PR.
Time Frame
from the first drug administration up to the first occurrence of progression or death (up to 24 months)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Liu, Doc
Phone
020-81332199
Email
victorlq@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yudong Li, Doc
Phone
020-81332199
Email
nihao_0105@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Liu, Doc
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
LI YuDong
City
Guanzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI YuDong, Doctor
Phone
17875111048
Email
nihao_0105@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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