Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine	Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.

Primary Outcome Measures

Name	Time	Method
Overall Clinical Response Rate (OCR)	After the first three cycles of therapy, an average of 9 weeks	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.
Partial Clinical Response Rate (PR)	After the first three cycles of therapy, an average of 9 weeks	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.
Complete Clinical Response Rate (CCR)	After the first three cycles of therapy, an average of 9 weeks	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.
Complete Pathologic Response Rate (cPR)	After the first three cycles of therapy, an average of 9 weeks	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Obafemi Awolowo University
🇳🇬
Ile-Ife, Nigeria
University of Chicago
🇺🇸
Chicago, Illinois, United States
University of Ibadan
🇳🇬
Ibadan, Nigeria