Breast Cancer
Conditions
Keywords
breast cancer, neoadjuvant, locally advanced
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.
Interventions
DRUGCapecitabine
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).
Sponsors
Breast Cancer Research Foundation
Roche Pharma AG
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Nigeria, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Capecitabine |
|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Complete Clinical Response Rate (CCR) | 0 percentage of participants |
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.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Complete Pathologic Response Rate (cPR) | 0 percentage of participants |
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.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Overall Clinical Response Rate (OCR) | 31.3 percentage of participants |
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.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Partial Clinical Response Rate (PR) | 5 participants |