Health Condition 1: null- Metastatic breast cancer after failure of standard combination therapy
Conditions
Interventions
Intervention1: Paclitaxel: Dosage form: Concentrate for solution for infusion
Dose: 175 mg/m2 as a 3-hour infusion in combination with intravenous Doxorubicin (50 mg/m2)
Frequency: Day 1 of each 21-
Sponsors
CJSC RCI Syntez Russia
Nexus Clinical Research India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Female patients at the age of >= 18 years old. •Patients with histologically or cytologically confirmed metastatic breast cancer. •Presence of measurable niduses as per RECIST criteria and presence of disease progression signs after previous therapy. •History of operative therapy and/or radiation treatment regimen. •Presence of unresectable distant metastases. •There should be, at least, 4 weeks after radiation therapy and, at least, 6 weeks after previous chemotherapy. •Previous therapy toxicity manifestation should be completely resolved. •Patients should be ambulatory and should be evaluated as per ECOG scale - 0 - 2 scores. •Adequate state of blood system and function of kidneys and liver: - absolute neutrophil count (ANC) >= 1.5Ñ?109/L; - platelet count >= 100Ñ?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 - negative serum HCG; •Fertile women must use a reliable method of contraception during the entire study period and for 3 months after the end of the study. •The desire and ability to sign and date the written informed consent to participate in the study prior to enrollment. The desire and ability of the patient to comply with the protocol requirements throughout the study.
Exclusion criteria
Exclusion criteria: •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. •Presence of confirmed brain metastases. •More than two courses of previous chemotherapy for breast cancer, including adjuvant and neoadjuvant therapy. •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. •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. •Gastric and duodenal ulcer disease •Presence of infections in active form. •Pregnancy and lactation •Fertile patients who do not agree to use effective methods of contraception. •Established impossibility of drug administration in the form of intravenous infusions. •Simultaneous participation in other clinical trials. •Hypersensitivity to Paclitaxel, Doxorubicin or Dexamethasone and other drug excipients. •Severe organic renal lesion, diabetes mellitus, chronic arterial insufficiency, thyroid diseases •Diseases of the central and peripheral nervous system, psychiatric disorders, including depressive disorders, seizures •Major surgery within two weeks prior to the study •Peripheral neuropathy more than second degree of severity •Active systemic infection requiring treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate (effect)Timepoint: After 3 chemotherapy courses. | — |
Secondary
| Measure | Time frame |
|---|---|
| All cases of AEs and SAEs related to the test drug administration.Timepoint: After the administration of first dose of study drug until final visit.;All cases of withdrawal for AE/SAE development.Timepoint: After the administration of first dose of study drug until final visit.;Efficacy profile in groups compared: to identify the incidence of complete and partial regression. stabilization and progression of the diseaseTimepoint: After 3 chemotherapy courses. | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed