NCT06035679 Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
| NCT ID | NCT06035679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Youzhi Zhu |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-08-17 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
Eligibility Criteria
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.
Contact & Investigator
zhu youzhi
STUDY CHAIR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT06035679 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06035679 currently recruiting?
Yes, NCT06035679 is actively recruiting participants. Contact the research team at zhu@fjmu.edu.cn for enrollment information.
Where is the NCT06035679 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06035679 clinical trial?
NCT06035679 is sponsored by Youzhi Zhu. The principal investigator is zhu youzhi at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.