breast cancer
Conditions
Interventions
experimental group:pegylated liposomal doxorubicin (PLD) plus cyclophosphamide combined with trastuzumab and pertuzumab followed by taxanes and trastuzumab and pertuzumab
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged from 18 to 70 years old; 2. Histologically confirmed as unilateral primary breast cancer and without previous treatment. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible; 3. HER-2 Positive (defined by IHC 3+ or ISH positive); 4. Tumor >= 2cmor lymph node–positive; 5. Patients must have at least one measurable disease according to RECIST 1.1; 6. ECOG (Eastern Cooperative Oncology Group) performance score=55 %; 8. BNP or NT-proBNP and cardiac troponin are normal; 9. Alanine aminotransferase(ALT)aspartate aminotransferase (AST) alkaline phosphatase(ALP) and serum total bilirubin are all = 3.0x10^9/L absolute neutrophil count (ANC) >= 1.5x10^9/L; platelets>=100x10^9/L; hemoglobin >= 90g/L; 11. Ability to understand and voluntarily receive the research procedures according to protocol, willingness to sign the written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer. 2. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 3. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator; 4. Patients with severe cardiac disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limitede.g., unstable angina pectorisclinical significance valvular diseasetransmural myocardial infarction measured by ECG, uncontrolled hypertension; 5. Patients with uncontrolled diabetes; 6. Severe or uncontrolled infections that may affect study treatment or evaluation, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.; 7. A history of other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin; 8. Participation in other clinical trials within 4 weeks before enrollment; 9. Women who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation; 10. Other conditions considered to be inappropriate to be enrolled by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical objective response rate (ORR) after the first four cycles;The clinical benefit rate after the first four cycles;The incidence and severity of adverse events;Breast conservation rate at surgery;The propotion of tumor shrinkage after the first four cycles;The clinical objective response rate (ORR) after neoadjuvant treatment; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed