- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347438
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
November 5, 2015 updated by: University of Chicago
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ibadan, Nigeria
- University of Ibadan
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Ile-Ife, Nigeria
- Obafemi Awolowo University
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Capecitabine
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Clinical Response Rate (OCR)
Time Frame: After the first three cycles of therapy, an average of 9 weeks
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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.
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After the first three cycles of therapy, an average of 9 weeks
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Partial Clinical Response Rate (PR)
Time Frame: After the first three cycles of therapy, an average of 9 weeks
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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.
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After the first three cycles of therapy, an average of 9 weeks
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Complete Clinical Response Rate (CCR)
Time Frame: After the first three cycles of therapy, an average of 9 weeks
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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.
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After the first three cycles of therapy, an average of 9 weeks
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Complete Pathologic Response Rate (cPR)
Time Frame: After the first three cycles of therapy, an average of 9 weeks
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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.
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After the first three cycles of therapy, an average of 9 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
June 29, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
November 5, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14201B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on Capecitabine
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Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
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Binghe XuHoffmann-La RocheUnknownSkin Diseases | Neoplasms by Site | Breast Neoplasms | Breast Diseases | Neoplasm MetastasisChina
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Jules Bordet InstituteCompletedBreast Cancer | Elderly PatientsBelgium
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Samsung Medical CenterCompletedAdvanced or Recurrent Esophageal Squamous Cell CarcinomaKorea, Republic of
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Fudan UniversityCompletedMetastatic Breast CancerChina
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Cancer Institute and Hospital, Chinese Academy...Hoffmann-La RocheUnknownCarcinoma, Invasive Ductal, BreastChina
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The First Affiliated Hospital of Zhengzhou UniversityRecruiting
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Hebei Medical UniversityCompletedGastroesophageal Junction AdenocarcinomaChina