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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Jiangsu Provincial People's Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wei Li, Ph.D
• Email: real.lw@163.com
• Phone: 025-68307102

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

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  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

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  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

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• Gut bacteria and diarrhea in breast cancer patients on pyrotinib

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• Pyrotinib + Dalpiciclib + Letrozole for ER-positive, HER2-positive advanced breast cancer

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• Evaluating Pyrotinib for HER2-positive Advanced Breast Cancer

  This study is testing if a new drug called Pyrotinib, given with standard chemotherapy, can help people with advanced HER2-positive breast cancer feel better and improve their treatment outcomes.

  Recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06770296

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.