Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer

Luye Pharma Group

Status

Unknown

Conditions

Breast Cancer

Treatments

Drug: paclitaxel liposome injection plus cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02142010

LY-TM-LPS-2014-01

Details and patient eligibility

About

The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.

Enrollment

67 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women aged ≥ 18 years and < 65 years,An estimated life expectancy of at least 12 months
ECOG 0-1
At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
Biopsy specimens are available for ER, PgR and Her2 analysis
Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
adequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL;
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
No obvious main organs dysfunction
patients must be accessible for treatment and follow-up and written informed consent

Exclusion criteria

Patient is pregnant or breast feeding
Inflammatory breast cancer and Metastatic breast cancer
Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
Has peripheral neuropathy
Treatment with any investigational drugs within 30 days before the beginning of study treatment
No psychiatric illness and other situations that would limit compliance of study
With a history of other malignant tumor
Known severe hypersensitivity to any drugs in this study