A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer

Study Overview
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Brief Summary
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Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer

Detailed Description
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The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined with pyrotinib in previously untreated histologically proven HER2 positive early breast cancer and evaluate the PCR DFS,OS and safety of the subjects.

Official Title
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A Multicenter, Open Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamb Vedotin Combined With Pyrotinib in Previously Untreated Histologically Proven HER2 Positive Early Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Disitamb Vedotin ,pyrotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender. 2. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC subjects: evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines. Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2 positive. Multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as HER2 positive by the central laboratory. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative). Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node involvement is determined by fine needle aspiration or coarse needle aspiration biopsy (if applicable). 3. When randomized, ECOG physical fitness status is 0 or 1 point. Exclusion Criteria: Previous history of invasive breast cancer. Stage IV breast cancer according to AJCC staging system version 8. Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease. DCIS medical history, except for the subjects who only received Mastectomy According to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including persistent or active infections, uncontrolled hypertension, kidney transplantation and active bleeding diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the researchers consider to be unfavorable for the participants to participate in the study or may affect adherence to the protocol. Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disitamb Vedotin combined with pyrotinib<br>Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day. | Drug: Disitamb Vedotin ,pyrotinib<br>* Disitamb Vedotin combined with pyrotinib<br>* Other names: Regular Visits;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response（pCR） | The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival （DFS) | The time from randomization until disease recurrence or death due to progression of the disease. | 3 years | 
| Overall Survival（OS） | It is defined as the time from the start of treatment to death for any reason. | 5year | 
| The Number of Participants Who Experienced Adverse Events (AE) | according to the CTCAE's grading criteria | 1 year | 
| Patient Report Outcome（PRO） | The report is directly obtained from the patient's self-report of their health status, functional status, and treatment experienceThe European O-rganization for Reasearch and Treatment of Cancer（QLQ-C30）、QLQ-BR32，EQ-5D-5L，PRO-CTCAE | 3years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-positive, RC48