Breast cancer
Conditions
Interventions
Inetetamab + Pyrotinib + Capecitabine :Preoperative neoadjuvant treatment using initumumab + pyrrotinib + capecitabine regimen
Sponsors
Cangzhou Hospital of integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Pathological examination confirmed that it is HER-2 positive invasive breast cancer; (HER2 positive is defined as immunohistochemistry (IHC) 3+ or IHC 2+ and further application of in situ hybridization (ISH) detection is HER2 gene amplification), regardless of Hormone receptor status (ER and PR); 3. Early or locally advanced breast cancer patients (stage II-III) (according to the eighth edition standard of AJCC staging manual for common tumors); 4. According to the guideline, the standard neoadjuvant treatment plan containing trastuzumab is evaluated as SD or PD after 2-4 cycles of treatment; 5. ECOG PS: 0-1 points; 6. The main organ function is normal, that is, it meets the following standards: (1) The standard of routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): Hb>=90g/L; ANC>=1.5x10^9/L; PLT>=90 x10^9/L; (2) The biochemical examination shall meet the following standards: TBIL=55%; 7. Female patients who have not undergone menopause or have not undergone surgical sterilization must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and they are willing to adopt appropriate methods during the trial and within 8 weeks after the last trial drug administration contraception; 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who are known to have a history of allergies to the drug components of this program; 2. Past application of other small molecule TKI drugs or ADC drugs (including: Nelatinib; Lapatinib; TDM1 and other drugs); 3. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 4. New York Heart Association (NYHA) scores to identify heart disease patients above grade II (including grade II); 5. Suffer from mental illness or psychotropic drug abuse and cannot cooperate; 6. Female patients during pregnancy or lactation; 7. Participating in other clinical trials at the same time; 8. The researcher believes that it is not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Miller-Payne classification;Invasive disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLuo Ruizhen
Cangzhou Hospital of integrated Traditional Chinese and Western Medicine
Outcome results
None listed