Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-042-07
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Complete pathological response rate (RCp).<br>Timepoints:4-6 weeks after the last chemotherapy.<br>
- Secondary Outcome Measures
Name Time Method