Clinical trial · Interventional
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
NCT05945368CI-TRIAL-00068005unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin mesylate injection、Pertuzumab、Trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin+Trastuzumab + Pertuzumab
- 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
- interventionNames
- Drug: Eribulin mesylate injection、Pertuzumab、Trastuzumab
Primary outcomes (1)
- measure
- Pathology Complete Response
- timeFrame
- 24 to 28 weeks
- 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.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.