Status:
COMPLETED
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
Detailed Description
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery. The required number of patients has been calculated following Simon's method. 43 p...
Eligibility Criteria
Inclusion
- Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
- Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
- Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
- Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
- At least a 6 month life expectancy.
- Neutrophils \> 1500; platelets \> 100000; haemoglobin \> 10 mg/dL.
- Adequate renal and hepatic functions, with serum creatinine \< 1.2 mg/dl and total bilirubin \< 2 mg/dl.
- Adequate contraceptive methods during the study and up to 3 months after.
- Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction \> 55%.
Exclusion
- Inflammatory carcinoma or stage I, II or IV breast cancer disease.
- Males.
- Active infection.
- Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
- Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
- Pre-existing motor or sensorial neuropathy \> grade 1.
- Inability for treatment compliance.
- History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
- History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
- History of myocardial infarction in the previous 6 months.
- Hypertension not controlled.
- Pregnant or lactating women.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00128856
Start Date
March 1 2003
End Date
January 1 2015
Last Update
March 6 2023
Active Locations (10)
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1
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
3
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
4
Complejo Hospitalario Unviesitario A Coruña
A Coruña, Spain, 15006