Stage II Breast Cancer Clinical Trial
Official title:
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
Verified date | November 2015 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.
Status | Terminated |
Enrollment | 80 |
Est. completion date | |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological confirmation of primary invasive breast cancer - Stage I-III operable breast cancer. - Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation - Women greater than 18 years of age - ECOG performance status 0-1 - WBC > 4000/mm3 - Platelet count > 100,000/mm3 - SGOT < 2x ULN - Calculated creatinine clearance > 50ml/min Exclusion Criteria: - Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study. - Pregnant or breast-feeding women - Inflammatory breast cancer - HER2 positive disease - History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency - Uncontrolled intercurrent illness - Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant. - Excisional biopsy performed prior to enrollment - Uncontrolled coagulopathy - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Faulkner Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Hoffmann-La Roche |
United States,
Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Med. 2014 Apr;3(2):293-9. doi: 10.100 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. | 3 years | No |
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