Status:
UNKNOWN
Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-70 years
Phase:
PHASE2
Brief Summary
Due to neoadjuvant therapy with trastuzumab and pertuzumab is less effective for HR+/HER2+ breast cancer, and the PHEDRA Clinical Study subgroup analysis showed that the addition of pyrotinib to trast...
Detailed Description
Different anti-HER2-targeting drugs act on different parts and types of HER2 molecules, so their mechanisms and effects are different. Trastuzumab and pertuzumab are the most commonly used anti-HER2 t...
Eligibility Criteria
Inclusion
- Women aged 18-70 with breast cancer;
- Pathologically confirmed unilateral invasive ductal carcinoma (with or without intraductal carcinoma components);
- Proposed to receive neoadjuvant therapy;
- Positive ER and/or PgR (defined as ≥10% positive immunohistochemical test);
- HER2 positive (defined as IMMUNOHISTOchemical HER2 ++, or HER2 ++ and in situ hybridization (ISH) results in HER2 gene amplification);
- There is no evidence of metastasis in clinical or imaging;
- ECOG score 0 or 1;
- White blood cell count ≥3.5×109/L, neutrophil count ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥90 g/L before neoadjuvant therapy;
- Before neoadjuvant therapy, AST and ALT \< 1.5 times the upper limit of normal value, alkaline phosphatase \< 2.5 times the upper limit of normal value, total bilirubin \< 1.5 times the upper limit of normal value; Serum creatinine \< 1.5 times the upper limit of normal value;
- LVEF≥55% on 2d echocardiography before neoadjuvant therapy;
- Signed informed consent.
Exclusion
- Clinical or imaging suspicion of lateral breast malignancy has not been confirmed;
- Prior malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer;
- The patient has been enrolled in other clinical trials;
- Patients suffering from serious systemic diseases and/or uncontrollable infections cannot be enrolled in the study;
- Severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension \> 150/90mmHg, myocardial infarction or cerebrovascular accident) within the first 6 months of randomization;
- Have a history of blood system diseases, especially platelet-related diseases;
- Patients with previous intestinal inflammation, intestinal dysfunction, severe diarrhea and constipation;
- People who are known to be allergic to chemotherapy drugs, targeted drugs or TKI drugs;
- Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment;
- Pregnant and lactation women;
- positive pregnancy test before drug use after joining the test;
- Mental illness, cognitive impairment, inability to understand the test protocol and side effects, inability to complete the test protocol and follow-up workers (systematic evaluation is required before the trial is enrolled);
- Persons without personal freedom and independent capacity for civil conduct.
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05430347
Start Date
April 15 2023
End Date
September 30 2025
Last Update
February 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China