Breast Cancer
Conditions
Keywords
Neoadjuvant chemotherapy., Stage III disease.
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%.
Interventions
DRUGGemcitabine
DRUGAdriamycine
DRUGPaclitaxel
Sponsors
Eli Lilly and Company
Bristol-Myers Squibb
Spanish Breast Cancer Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed