None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with cyclophosphamide, at a dose of 600 mg / m2, IV, on day 1 of each cycle of 21 days, for 4 cycles (12 weeks) + Doxorubicin, at a dose of 60 mg / m2, IV, day 1 of each cycle of 21 days for 4 cycles (12 weeks). After these 12 weeks, this group will start treatment with Ixabepilone, at a dose of 40 mg / m2, IV, on day 1 of each cycle of 21 days, for a total of 4 cycles (12 weeks). At the end of this stage, patients will undergo surgery: A quadrantectomy with axillary d
This group will be treated with cyclophosphamide, at a dose of 600 mg / m2, IV, on day 1 of each cycle of 21 days, for 4 cycles (12 weeks) + Doxorubicin, at a dose of 60 mg / m2, IV, day 1 of each cycle of 21 days for 4 cycles (12 weeks). After these 12 weeks, this group will start treatment with Paclitazel, at a dose of 80 mg / m2, IV, every week for 12 weeks. At the end of this stage, patients will undergo surgery: A quadrantectomy with axillary dissection or a modified radical mastectomy, acc
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Informed consent signed in writing, 2) Population under study: a) Invasive adenocarcinoma of primary breast, confirmed by histology. b) The tumors must have a negative state regarding the estrogen receptor (ER) and a negative expression regarding HER-2 / neu. c) Without previous treatment against breast cancer excluding the treatment against DCIS. d) Patients who received radiotherapy against DCIS can be enrolled. e) No disease due to a previous malignancy during ≥ 5 years. f) Kamofsky index (KPS) of 80 - 100. g) Accessible for treatment and follow-up. h) MUGA or baseline echocardiogram demonstrating an LVEF of ≥ 50%. i) Adequate recovery from a recent surgery. 3) Laboratory parameters a) Absolute neutrophil count (ANC) ≥ 1500 / mm3. b) Total bilirubin ≤ 1.5 times the upper limit of the normal range (ULN). c) AST or ALT ≤ 2.5 times the upper limit of the normal range (LSN). d) Platelets> 100,000 / mm3. e) Serum creatinine ≤ 1.5 x ULN or 24 hour creatinine clearance> 60 ml / min. f) Normal PTT and INR or PT <1.5 xLSN. 4) Age and sex Women over 18 years of age. a) Women of childbearing age (WOCBP) should use an appropriate contraceptive method throughout the study and for a maximum of 8 weeks after the administration of the last dose of the product under investigation.
Exclusion criteria
Exclusion criteria: 1. WOCBP who do not want or can not use an acceptable method to avoid pregnancy. 2. Women who are pregnant or breastfeeding. 3. Evidence of metastatic breast cancer according to the standard classification of tumor development. 4. Evidence of inflammatory breast cancer. 5. Evidence of sensory or motor neuropathy at baseline. 6. Clinical history and intercurrent diseases 7. Infection with the human immunodeficiency virus (HIV) confirmed. 8. Serious intercurrent infections or non-malignant diseases that are not controlled or in which this treatment may endanger the control of the disease. 9. Psychiatric disorders or other illnesses that do not allow the patient to comply with the requirements of the protocol. 10. Clinically significant history of cardiovascular disease. 11. Patients who are not able to undergo breast and / or axillary surgery. 12. Current participation in a study with another drug. 13 Patients who received previous treatment with anthracyclines. 14. Confirmed allergy to any of the drugs under study or agents containing Cremophor® EL. 15. Other standard or investigational antitumor treatments. 16. The administration of the following medication should be suspended 72 hours before beginning treatment with AC: barbiturates, phenytoin, doral hydrate, corticosteroids, succinylcholine, allopurinol, imipramine and phenothiazines. 17. Prisoners or patients institutionalized for the treatment of a psychiatric or physical illness may not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The rate of RCp is defined as the number of patients that achieve a CR between the total number of patients that enter this analysis. The pCR will be defined as absence of histological evidence of residual invasive adenocarcinoma of the breast and lymph nodes of the axilla, with or without the presence of DCIS in the breast. This histological evaluation will be performed in the lymph nodes of the breast and axilla, independently of the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in breast tissue. Measure:Complete pathological response rate (RCp). Timepoints:4-6 weeks after the last chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The clinical objective response rate is defined as the sum of the Complete Response (CR) plus the Partial Response (PR) rate. CR is defined as the total disappearance of clinically palpable detectable malignant disease and / or the disappearance of radiological evidence of the tumor in the breast and ipsilateral axillary lymph nodes (mammography, ultrasound, CT, MRI). RP is defined as the clinical evidence of a reduction of the total tumor size by ≥50% in the total sum of the diameters of the axillary and breast lesions, the same imaging methods used to evaluate the RC. Measure:Clinical objective response rate. Timepoints:4-6 weeks after the last chemotherapy. ; Outcome name:A peripheral blood sample will be obtained to extract DNA and study the genetic variation and response to the drug. A sample of the tumor tissue will be obtained for mRNA analysis before treatment with AC. Measure:Pharmacogenomics. Timepoints:Blood sample: At any time during the study. Tissue sample: Within 2 weeks prior to the first dose of AC. ; Outcome name:Criterion 1: Clinical evaluation of all unwanted medical events, which occur after the administration of the research drug. The severity of these will be determined by NCI s Common Terminology Criteria for Adverse Events (CTCAE version 3). Criterion 2: Panels of hematology and serum chemistry. Criterion 3: Determination of the number of interruptions, dose reductions or suspension of treatment, due to drug-related toxicity. Measure:Safety: 1) Frequency of all adverse events. 2) Abnormalities in laboratory tests. 3) Frequency of dose interruptions, dose reductions and suspension of treatment due to toxicity. Timepoints:Criteria 1 and 2: Weekly during treatment and during follow-up. Criterion 3: When the event occurs. | — |
Countries
Argentina, Austria, France, Germany, India, Italy, Korea South, Peru, Philippines, Russian Federation, Singapore, Spain, Taiwan, United Kindgdom, United States
Outcome results
None listed