Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
Detailed description
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation. This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
Interventions
DRUGPegylated Liposomal Doxorubicin
First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6. Second phase PLD：MTD. IV, d1, q21d×6.
DRUGAlbumin-bound paclitaxel
220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
DRUGTrastuzumab
8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Peking Union Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document; 2. Female patients aged from 18 to 70 years old; 3. Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible; 4. Clinical stageⅡ-Ⅲ; 5. HER-2 Positive（defined by: IHC 3+ or ISH positive）; 6. Without previous treatment for this breast cancer; 7. Patients must have at least one measurable disease according to RECIST 1.1; 8. ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points; 9. LVEF≥55%; 10. Normal ECG; 11. Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。 12. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN; 13. Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.
Exclusion criteria
1. New York Heart Association (NYHA) class ≥Ⅱ heart failure. 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. participating in other clinical trials within 4 weeks before this study. 5. Serious heart disease, including but not limited to: 1\) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive. 9\. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years. 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 | Description |
|---|---|---|
| Pathological complete response(pCR) rate | 5 months | Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Breast conserving surgery | 5 months | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy |
| Rate of surgery | 5 months | Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy |
| adverse events | 5 months | Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 |
Countries
China
Contacts
Primary ContactFei Ma, MD
Outcome results
None listed