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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel

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 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 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 not controlled.

• Pregnant or lactating women.