Clinical trial NCT00347438: Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant
locally advanced
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
name: Roche Pharma AG
First posted: 2006-07-04
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Clinical Response Rate (OCR)
timeFrame: After the first three cycles of therapy, an average of 9 weeks
measure: Partial Clinical Response Rate (PR)
timeFrame: After the first three cycles of therapy, an average of 9 weeks
measure: Complete Clinical Response Rate (CCR)
timeFrame: After the first three cycles of therapy, an average of 9 weeks
measure: Complete Pathologic Response Rate (cPR)
timeFrame: After the first three cycles of therapy, an average of 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ibadan
country: Nigeria
facility: University of Ibadan
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University
Study officials:
affiliation: University of Chicago
name: Olufunmilayo I Olopade, MD
role: PRINCIPAL_INVESTIGATOR
References: