Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine
Intervention description: 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).
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; neoadjuvant; locally advanced

Summary:

      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.
    

Eligibility criteria:

        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