- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945368
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Qiang Liu, Doc
- Phone Number: 020-81332199
- Email: victorlq@hotmail.com
Study Contact Backup
- Name: Yudong Li, Doc
- Phone Number: 020-81332199
- Email: nihao_0105@163.com
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China
- Recruiting
- LI YuDong
-
Contact:
- LI YuDong, Doctor
- Phone Number: 17875111048
- Email: nihao_0105@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eribulin+Trastuzumab + Pertuzumab
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 to 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from the first drug administration up to the first occurrence of progression or death (up to 24 months)
|
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
|
At baseline, 12 and 24 weeks
|
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
|
At baseline, 12 and 24 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Qiang Liu, Doc, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-KY-138
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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