Combination therapy for HER2-positive 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 is an observational study that aims to evaluate the efficacy of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy in treating HER2-positive breast cancer. It will enroll 30 female patients with early to locally advanced stages of the disease. The primary endpoint is to assess the total pathological complete response rate (tpCR) following treatment. The study also seeks to observe the effectiveness of a step-down neoadjuvant therapy approach for specific early-stage breast cancer patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged 18-75 years;
2. Her2-positive breast cancer confirmed by pathology;
3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
4. ECOG PS: 0-1 score;
5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
6. Normal function of major organs means that the following criteria are met:

(1) Blood test neutrophil (ANC) \>=1.5x10\^9/L; Platelet count (PLT) \>=90x10\^9/L; Hemoglobin (Hb) \>=90g/L; (2) Total bilirubin (TBIL) \<=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=1.5xULN; Alkaline phosphatase \<=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) \<=1.5xULN; (3) Left ventricular ejection fraction (LVEF) \>=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Known allergic history of the drug components of this protocol;
2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
3. Participated in clinical trials of other antitumor drugs within four weeks;
4. Stage IV (metastatic) breast cancer;
5. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);
7. Patients with active infection and severe mental illness;
8. Pregnant or lactating patients;
9. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

Where it's running

• The First Affiliated Hospital of Fujan Medical University
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: zhu youzhi
• Email: zhu@fjmu.edu.cn
• Phone: 17759120588

Similar studies

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

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• 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

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

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

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

• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

  This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07393425

• Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy

  This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07340398

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.