Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery. The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.

Official Title
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A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible. Ability to provide written informed consent prior to study-specific screening procedures TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled. Age 18 years or older Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential). Performance status 0-1 Required Initial Laboratory Data: Granulocytes >=1,200/µl Platelet count >=100,000/µl Calculated Creatinine Clearance > 30 mL/min Total bilirubin <= Upper Limit Normal Alkaline Phosphatase <=Upper Limit Normal SGPT, SGOT <=Upper Limit Normal Normal chest x-ray Exclusion Criteria: HER2 positive breast cancer Pregnant or lactating woman Life expectancy < 3 months Serious, uncontrolled, concurrent infection(s) Any prior fluoropyrimidine therapy or other chemotherapy Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency. Patients who have received more than four weeks of tamoxifen therapy for this malignancy. Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin Any of the following laboratory values: Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L) Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation) Serum bilirubin > upper normal limit. SGOT, SGPT > upper normal limit

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles. | Drug: Capecitabine<br>* Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Clinical Response Rate (OCR) | Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions. | After the first three cycles of therapy, an average of 9 weeks | 
| Partial Clinical Response Rate (PR) | Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions. | After the first three cycles of therapy, an average of 9 weeks | 
| Complete Clinical Response Rate (CCR) | Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. | After the first three cycles of therapy, an average of 9 weeks | 
| Complete Pathologic Response Rate (cPR) | Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. | After the first three cycles of therapy, an average of 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant, locally advanced