Combining Disitamb Vedotin and Pyrotinib for HER2-positive Early Breast Cancer

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

This study is testing if combining two drugs, Disitamb Vedotin and pyrotinib, can help people with early HER2-positive breast cancer who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: pyrotinib
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06001086 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Disitamb Vedotin in combination with pyrotinib for patients with previously untreated HER2-positive early breast cancer. Participants will be assessed for pathological complete response (PCR), disease-free survival (DFS), overall survival (OS), and safety outcomes. The study focuses on patients with histologically confirmed HER2-positive tumors, ensuring rigorous eligibility criteria based on ASCOCAP guidelines. The trial is designed to provide insights into a potentially effective treatment regimen for this specific cancer type.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 75 with histologically confirmed HER2-positive early breast cancer.

Not a fit: Patients with HER2-negative breast cancer or those who have received prior treatment for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HER2-positive early breast cancer.

How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies in HER2-positive breast cancer, indicating potential for success.

Eligibility criteria

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:

1. evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
2. 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.
3. 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.
4. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).
5. 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:
   1. Previous history of invasive breast cancer.
   2. Stage IV breast cancer according to AJCC staging system version 8.
   3. Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.
   4. DCIS medical history, except for the subjects who only received Mastectomy
   5. 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.
   6. Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wei Li, Ph.D

Conditions Breast Cancer; HER2-positive; RC48