Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00128856
- Lead Sponsor
- Spanish Breast Cancer Research Group
- 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 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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- 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%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + Adriamycine + Paclitaxel Adriamycine Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles. Gemcitabine + Adriamycine + Paclitaxel Gemcitabine Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles. Gemcitabine + Adriamycine + Paclitaxel Paclitaxel Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.
- Primary Outcome Measures
Name Time Method Pathological complete response (pCR) rate Up to week 15 pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR) Up to week 12 Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
Conservative surgery rate Up to week 15 To determine the percentage of conservative surgery rate versus other surgery
The Number of Participants Who Experienced Adverse Events (AE) Through study treatment up to surgery According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
Disease-free survival Up to 5 years since surgery Time from the start of treatment to the progression of the disease (if it happens)
Tissue molecular markers and their correlation with response Up to week 15 Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.
Trial Locations
- Locations (10)
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Complejo Hospitalario Unviesitario A Coruña
🇪🇸A Coruña, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain