Neoadjuvant treatment for HER2-positive breast cancer using SHR-A1811 and pyrotinib

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 phase II trial evaluates the efficacy and safety of SHR-A1811, either alone or in combination with pyrotinib maleate, as a neoadjuvant treatment for patients with Stage II-III HER2-positive breast cancer. Participants will receive the treatment for six cycles before undergoing surgery within four weeks after the therapy. Efficacy will be assessed every two cycles to monitor the response to the treatment. The study aims to provide insights into the potential benefits of this combination therapy in improving surgical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients aged ≥ 18 but ≤ 75 years
* Histologically confirmed to be HER2-positive invasive breast cancer
* Treatment-naive patients with stage II-III
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Good level of organ function

Exclusion Criteria:

* Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
* Received any other anti-tumor therapy at the same time
* Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
* Stage IV breast cancer
* With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
* Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
* Participated in other drug clinical trials within 4 weeks before enrollment
* History of allergies to the drug components of this protocol
* Clinically significant pulmonary diseases
* Clinically significant cardiovascular diseases
* History of immunodeficiency
* Active hepatitis and liver cirrhosis

Where it's running

• Shengjing Hospital affiliated to China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Caigang Liu, MD — Shengjing Hospital
• Study coordinator: Nan Niu, MD
• Email: niunannancy@163.com
• Phone: 86-18940256668

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

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

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

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Evaluating an intelligent management system for medication adherence in breast cancer treatment

  This study is testing a new patient management system to see if it helps women with HER2-positive breast cancer stick to their medication better than usual methods while they receive pyrotinib treatment.

  Recruiting Phase 2/3 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT06958627

• Combining chemotherapy with pyrotinib and trastuzumab for HER2-positive breast cancer

  This study is testing whether combining chemotherapy with two targeted drugs, pyrotinib and trastuzumab, can help people with HER2-positive breast cancer respond better to treatment before surgery.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou · NCT06832904

• Using pyrotinib and trastuzumab for maintenance therapy in HER2-positive breast cancer

  This study is testing if using the drugs pyrotinib and trastuzumab together can help people with advanced HER2-positive breast cancer stay healthier and prevent brain tumors after their initial treatment.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT06754059

• Combining Pyrotinib and Capecitabine for HER2 Positive Early-stage Breast Cancer Treatment

  This study is testing if combining two drugs, Pyrotinib and Capecitabine, can help women with early-stage HER2 positive breast cancer after surgery feel better compared to other treatments their doctors choose.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06035016

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.