Breast cancer Cancer Breast cancer
Conditions
Interventions
It will be performed in the First Hospital of China Medical University, Shengjing Hospital of China Medical University, The Fourth Affiliated Hospital of China Medical University, Liaoning Cancer Hosp
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients at the age of = 18 years and = 65 years who received first treatment 2. ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 3. Histologically confirmed invasive breast cancer with a primary tumor diameter of more than 2 cm; TNM staging T2-3, N2 or N3, M0 4. Pathologically confirmed HER2-positive breast cancer, which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification 5. Known state of hormone receptors and progesterone receptor is known 6. The functional level of the main organs must meet the following requirements (no blood transfusion and no use of leukocytes- and platelets-raising drugs in 2 weeks before screening): absolute neutrophil count (ANC) = 1.5 × 109/L, platelet (PLT) count = 90 × 109/L, hemoglobin (Hb) = 90 g/L, total bilirubin (TBIL) = upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 × ULN, alkaline phosphatase = 2.5 x ULN, blood urea nitrate (BUN) and creatinine (Cr) 55%, corrected QT interval by Fredericia (QTcF) < 470 ms 7. For women who are not menopausal or who have not undergone surgical sterilization, they agree to stay abstinent or use effective contraceptive methods during the whole treatment period and for at least 7 months after the last administration during the study period 8. Volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer 2. Patients who had received antineoplastic therapy or radiotherapy for any malignant tumors, but excluding cured cervical cancer in situ, basal cell carcinoma or squamous cell carcinoma 3. Patients who are receiving anti-cancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy 4. Those who had undergone major breast cancer-free operations within 4 weeks before randomization or who had not yet fully recovered from such surgeries 5. Severe cardiac diseases or discomforts 6. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption 7. Anyone with known history of allergy to the components of study drugs; history of immunodeficiency, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation 8. Female patients during pregnancy and lactation, those with fertility and providing positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures throughout the trial 9. Patients with severe concomitant diseases or other complications that interfere with planned treatment or in any other case considered unsuitable by the researchers to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathologic complete response (tpCR) rate. Hematoxylin-eosin staining will be performed to observe the presence of residual invasive carcinoma in the surgical sections. If there is no residual invasive carcinoma (ypT0/isypN0), it will be regarded as total pathologic complete response. tpCR rate is the percentage of total number of patients having total pathologic complete response among total number of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR): It is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) during receiving neoadjuvant therapy. ORR will be assessed according to RECIST v1.1 guideline. 2. Eastern Cooperative Oncology Group (ECOG) performance status score: It is a 5-point measure indicating a subject’s general health status and treatment tolerance. Higher points indicate poor performance status. ECOG performance status will be evaluated on the 1st day of each treatment session and before surgery. 3. Routine blood test: Hemoglobin level, red blood cell, platelet count, white blood cell, and neutrophil counts will be determined before administration on the 1st day of each treatment session (or within 3 days before administration) and before surgery. 4. Biochemical indicators: blood levels of sodium, potassium, chlorine, calcium, magnesium, cholesterol, triglyceride, glucose, urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, total bilirubin, and direct bilirubin will be measured before administration on the 1st day of each treatment session (or within 3 days before administration) and before surgery. 5. Routine urine test: Protein, glucose, and blood in urine will be measured before surgery. If the urine protein is tested positive (two or more ++), a 24-hour urine protein test will be performed. | — |
Countries
China
Contacts
Public ContactFeng;Fan Jin;Yao
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Outcome results
None listed