Status:
COMPLETED
Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Fudan University
Ruijin Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.
Detailed Description
Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials...
Eligibility Criteria
Inclusion
- Women aged ≥ 18 years and \< 70 years
- Karnofsky performance status (KPS) ≥ 70
- At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), large operable (T≥3 cm and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
- 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
- An estimated life expectancy of at least 12 months
- Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
- 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
- Written informed consent according to the GCP
Exclusion
- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
- Metastatic breast cancer
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- 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
- inadequate 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; inadequate renal function (creatinine \> 1.0 times UNL and in case of limit value, Creatinine clearance \< 60 ml/min)
- Contraindication for using dexamethasone
- 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 ≥ grade 1
- Patient is pregnant or breast feeding
- Known severe hypersensitivity to any drugs in this study
- Treatment with any investigational drugs within 30 days before the beginning of study treatment
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01203267
Start Date
December 1 2007
End Date
December 1 2008
Last Update
September 16 2010
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032