Health Condition 1: null- Metastatic breast cancer
Conditions
Interventions
Intervention1: Docetaxel: Dosage form: Concentrate for solution for infusion
Dose: Docetaxel 75 mg/m2 as a 1-hour infusion preceded by Doxorubicin 50 mg/m2 intravenous injection [Premedication: Dexam
Sponsors
CJSC RCI Syntez Russia
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients at the age of >= 18 years old. 2.Patients with histologically or cytologically confirmed metastatic breast cancer. 3.Presence of measurable niduses as per RECIST criteria. 4.Absence of prior chemotherapy for metastatic breast cancer. 5.Presence of unresectable distant metastases. 6.Patients should be ambulatory and should be evaluated as per ECOG scale - 0 - 2 scores. 7.Adequate state of blood system and function of kidneys and liver: - absolute neutrophil count (ANC) >= 1,5Ñ?109/L; - platelet count >= 75Ñ?109/L; - hemoglobin >= 90g/L; - serum creatinine level exceeds not more than 2.5 times upper limit of normal (ULN), - level of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceeds not more than 2.5 times ULN - bilirubin level in blood serum exceeds not more than 1.5 times ULN - alkaline phosphatase exceeds not more than 2.5 times ULN. 8.Fertile women must use a reliable method of contraception (acceptable methods of contraception in this study are: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, sustained-release injectable contraceptives, partner vasectomy and double barrier method (condom or diaphragm with spermicide) during the entire study period and for 3 months after the end of the study). 9.The desire and ability to sign and date the written informed consent to participate in the study prior to enrollment. 10.The desire and ability of the patient to comply with the protocol requirements throughout the study.
Exclusion criteria
Exclusion criteria: 1.A history of other malignancies, except for patients whose disease has not been observed for the last 5 years, patients with completely healed basal cell carcinoma or completely healed carcinoma in situ. 2.Presence of confirmed brain metastases. 3.The presence of concomitant disease or pathology, which make participation of patient in the study impossible, or any serious illness or condition that would pose a threat to patient safety in case of participation in the study - unstable angina, myocardial infarction or congestive heart failure class third or fourth, A history or present clinically significant ventricular or atrial arrhythmia more than and equal to second degree of severity. 4.Any organic or mental disorder, which, in the opinion of the Investigator, may interfere with the patient participation in the study or interfere with the interpretation of study results. 5.Presence of infections in active form. 6.Pregnancy and lactation. 7.Fertile patients who do not agree to use effective methods of contraception. 8.Established impossibility of drug administration in the form of intravenous infusions. 9.Simultaneous participation in other clinical trials. 10.Hypersensitivity to Docetaxel, Doxorubicin or Dexamethasone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Frequency of clinical response (according to RECIST criteria) after 3 and 6 courses of chemotherapy. 2.All AE and SAE cases related to the study drug administration. 3.All the cases of withdrawal for adverse events/serious adverse events. Timepoint: 1. After 3 and 6 courses of chemotherapy. 2. Throughout the study, after the first dose administration 3. Throughout the study, after the first dose administration | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed