Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00347438
• Other study ID #: 14201B
• Status: Terminated
• Phase: Phase 2
• First received: June 29, 2006
• Last updated: November 5, 2015
• Start date: September 2006
• Est. completion date: March 2013

Study information

• Verified date: November 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardNigeria: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Capecitabine
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).

Locations

Country	Name	City	State
Nigeria	University of Ibadan	Ibadan
Nigeria	Obafemi Awolowo University	Ile-Ife
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Breast Cancer Research Foundation, Roche Pharma AG

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No