A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: EddingPharm Oncology Co., LTD.; Taizhou EOC Pharma Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Epirubicin; Lapatinib; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

1. the first diagnosis of invasive breast cancer, confirmed by histology or cytology, and surgical resection of the primary lesions before receiving any anti breast cancer treatment;

2. female patients, aged 18 years and less than 80 years of age;

3. surgical resection of the primary tumor pathological examination, showed HER2 positive (defined as immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization (FISH) positive);

4. hormone receptor status is known, lymph node positive or sentinel lymph node negative but high risk factors

5. the eastern oncology cooperative group (ECOG) patients with physical status score was 0 -2;

6. baseline LVEF >50%

7. the relevant institutional review board (IRB) or independent ethics committee (IEC) written informed consent

Exclusion Criteria:

1. the subjects in pregnancy or lactation;

2. pregnant women may be within the first 7 days before pregnancy test positive (urine or serum).

3. received chemotherapy, endocrine or anti HER2 anti-tumor therapy;

4. congestive heart failure, unstable angina, heart failure or myocardial infarction and other diseases;

5. other invasive tumors (including the second primary breast cancer), may affect the outcome of the evaluation and program compliance; but the treatment of patients with disease free survival at least more than 5 years can be selected;

6. with chronic liver disease in patients with liver dysfunction and / or with clinical manifestations: the serum total bilirubin > 2.5 * ULN; or INR = 1.5 but no bilirubin. serum ALT or AST> * 3 * ULN; alkaline phosphatase >2.5 * ULN; ALT or AST can be gradually increased, but with gradually increasing fatigue, nausea and vomiting, fever, right upper quadrant pain or tenderness

7. hematopoietic dysfunction, defined as follows: neutrophil count (ANC) <1.5 * 109/L; platelet <100 * 109/L; hemoglobin <9 g/dL;

8. other serious diseases, including: congestive heart failure (heart function NYHA grade II, III, IV) or occurred within 6 months of congestive heart failure, unstable angina, arrhythmia, myocardial infarction patients can't control or other severe cardiovascular disease; breathing at rest or need oxygen therapy; serious infection; uncontrolled diabetes;

9. there is a serious psychological or mental abnormalities, estimated that the participants to participate in this study is not strong;

10. known to study drug allergy;

11. the past 30 days participated in the study of other drug clinical trials.

1, failed to complete the clinical trial of at least 1 cycles according to the program, can not carry out safety and efficacy evaluation 2, a serious violation of this research program, not in accordance with the prescribed dose, method and course of medication.

Patients will receive lapatinib treatment, until a predetermined end end point, or development of unacceptable toxicity, or withdrawal of consent, or illness or death, to appear before the subject.