Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

Study Overview
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Brief Summary
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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
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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 have shown that pathological complete response (pCR) is an independent predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast cancer patients.

Official Title
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Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel, Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel plus carboplatin (PCb) Arm<br>4 cycles of neoadjuvant paclitaxel plus carboplatin | Drug: Paclitaxel, Carboplatin<br>* Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete remission (pCR) rate |  | after 4 cycles of preoperative treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression | 4 months during neoadjuvant therapy | 
| clinical response rate |  | after 4 cycles of preoperative therapy | 
| Predictive markers of weekly paclitaxel plus carboplatin |  | after 4 cycles of preoperative treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Neoadjuvant, Chemotherapy, Paclitaxel, Carboplatin, Pathological Complete Remission