Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients | RxWiki

Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients

Overview[ - collapse ][ - ]

Purpose	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, confirmed by true-cut or open biopsy.
Condition	Breast Cancer
Intervention	Drug: gemcitabine Drug: doxorubicin Drug: paclitaxel
Phase	Phase 2
Sponsor	Spanish Breast Cancer Research Group
Responsible Party	Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier	NCT00128856
First Received	August 9, 2005
Last Updated	August 29, 2005
Last verified	August 2005

Tracking Information[ + expand ][ + ]

First Received Date	August 9, 2005
Last Updated Date	August 29, 2005
Start Date	December 2002
Estimated Primary Completion Date	August 2005
Current Primary Outcome Measures	Pathological response rate
Current Secondary Outcome Measures	Overall response rate (complete + partial responses) Conservative surgery rate Toxicity Disease-free survival Tissue molecular markers and correlation with response XPD single nucleotide polymorphisms (SNPs) and correlation with treatment response

Descriptive Information[ + expand ][ + ]

Brief Title	Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Official Title	Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-Doxorubicin-Paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
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, confirmed by true-cut or open biopsy.
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 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Breast Cancer
Intervention	Drug: gemcitabine Drug: doxorubicin Drug: paclitaxel
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	43
Estimated Completion Date	August 2005
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - 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 (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 (EKG) and left ventricular ejection fraction (LVEF) > 55%. Exclusion Criteria: - 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 (HT) not controlled. - Pregnant or lactating women.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Spain

Administrative Information[ + expand ][ + ]

NCT Number	NCT00128856
Other Study ID Numbers	GEICAM 2002-01
Has Data Monitoring Committee	Not Provided
Information Provided By	Spanish Breast Cancer Research Group
Study Sponsor	Spanish Breast Cancer Research Group
Collaborators	Eli Lilly and Company Bristol-Myers Squibb
Investigators	Study Chair: Antonio Antón, Md., PhD. Spanish Breast Cancer Research Group (GEICAM)Study Chair: Pedro Sánchez-Rovira, MD., PhD Spanish Breast Cancer Research Group (GEICAM)
Verification Date	August 2005

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