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

NCT02142010 | Unknown DMC

• 1 other identifier: LY-TM-LPS-2014-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete remission (pCR) rate

  after 4 months of preoperative treatment

Secondary Outcomes (2)

• Adverse Events as a Measure of Safety and Tolerability

  4 months during neoadjuvant therapy

• clinical response rate

  after 4 months of preoperative therapy

Study Arms (1)

paclitaxel liposome injection plus cisplatin

OTHER

Drug: paclitaxel liposome injection plus cisplatin

Interventions

paclitaxel liposome injection plus cisplatin DRUG

Paclitaxel liposome injection 80 mg/m2, given on days 1, 8,15 and 22 of a 28-day cycle. Cisplatin 25 mg/m2, given on days 1, 8 and 15 of a 28-day cycle, for 4 cycles(4 months)

paclitaxel liposome injection plus cisplatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Luye Sike Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jinsong Lu, MD

CONTACT

lujjss@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 20, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

CN (1)