Status:
UNKNOWN
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery
Lead Sponsor:
Cancer Research Network
Collaborating Sponsors:
Sanofi
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors a...
Detailed Description
Neoadjuvant (primary) chemotherapy is being used more frequently in locally advanced breast cancer in an effort to reduce the size of the primary tumor prior to surgery and to eliminate micrometastati...
Eligibility Criteria
Inclusion
- Women or men \> 18 years old with histologically confirmed, by needle core biopsy (not FNA), locally advanced or inflammatory breast cancer.
- All patients must have either T2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a T3 N0-N2; T4 any N; or any T with N2 or N3 clinical evidence of disease. Stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. Patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. Patients must have measurable disease defined as a breast lesion \> 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
- Pre-and Post-menopausal female and male patients are eligible. Women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
- Life expectancy of greater than 6 months.
- Bone scan and CAT scan of chest and abdomen negative for metastatic disease
Exclusion
- Patients with metastatic disease.
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (NYHA \> Class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
- Women who are breast-feeding.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00251329
Start Date
May 1 2003
Last Update
April 4 2007
Active Locations (6)
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1
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
2
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
3
Mount Sinai Comprehensice Cancer Center
Miami, Florida, United States, 33140
4
Oncology /Hematology Associates of Florida
Miami, Florida, United States, 33176