Breast Cancer
Conditions
Interventions
Group 1:pegylated liposomal doxorubicin + cyclophosphamide sequential taxine + trastuzumab ± pertuzumab regimen
Group 2:epirubicin + cyclophosphamide sequential taxine + trastuzumab ± pertuzumab regimen
Sponsors
Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female aged >=18 years; 2. Histologically confirmed as primary invasive breast cancer and without previous treatment; 3. HER-2 Positive which defined by IHC 3+ or ISH positive; 4. Need to receive neoadjuvant chemotherapy considered by the investigator; 5. 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. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 2. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator; 3. Be attending in other clinical trials; 4. Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation; 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical objective response rate after the first four cycles ;Clinical benefit rate after the first four cycles ;Clinical objective response rate after neoadjuvant treatment;five-year disease free survival rate;five-year survival rate;The incidence and severity of adverse events;the propotion of tumor shrinkage after the first four cycles;rate of breast conservative operation; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed