Clinical trial NCT03994107: Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
Official title: A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-06-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathological complete response(pCR) rate
timeFrame: 5 months
Secondary outcomes:
measure: Rate of Breast conserving surgery
timeFrame: 5 months
measure: Rate of surgery
timeFrame: 5 months
measure: adverse events
timeFrame: 5 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fei Ma
state: Beijing
Study officials:
affiliation: Cancer Hospital Chinese Academy of Medical Science
name: Fei Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: