None listed
Conditions
Brief summary
Use of chemotherapy and growth factors can affect the number of stem cells and cancer cells in blood circulation. Few studies have also shown that number of cancer cells can be of prognostic significance. There are no studies till date which have looked systematically at the influence of chemotherapy and growth factors on these cells. Hence present study was designed to answer these questions. The results of the study may not directly influence the way we treat the patients today but will definitely help us to understand the complex nature of breast cancer.
Interventions
It is a research study where patients who are receiving standard chemotherapy (docetaxel 100mg/m2 every 3 weeks) and growth factor (pegfilgrastim 6 mg subcutaneous injection 24 hours after chemotherapy) for metastatic breast cancer will be asked to give blood sample (10 ml) daily from Day 4- Day 11 after first dose of chemotherapy. One more blood sample will be collected on D21. There will not be any further assessment or follow-up as part of the trial. The blood sample will be analysed for stem
It is a research study where patients who are receiving standard chemotherapy (docetaxel 100mg/m2 every 3 weeks) and growth factor (pegfilgrastim 6 mg subcutaneous injection 24 hours after chemotherapy) for metastatic breast cancer will be asked to give blood sample (10 ml) daily from Day 4- Day 11 after first dose of chemotherapy. One more blood sample will be collected on D21. There will not be any further assessment or follow-up as part of the trial. The blood sample will be analysed for stem cells and tumor cells and the effect of treatment will be studied. The patients will continue to receive their treatment as part of routine care.
Sponsors
Department of Medical Oncology, Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to consent 2. Cytological or histological diagnosis of breast cancer 3. Evidence of metastases 4. Being considered for docetaxel chemotherapy 5. performance status = 2. 6. Adequate organ functionHematological- Hb> 90g/L, Absolute Neutrophil Count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L.Liver function - bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT)/ Alkaline Phosphatase (ALP) = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min.
Exclusion criteria
1. Splenomegaly as detected clinically2. Previous treatment with docetaxel.3. Prior pelvic irradiation.4. Pregnancy or lactation. 5. Active second malignancy or past history of any cancer with in last 5 years.6. Patients on other investigational drugs within last 30 days.
Outcome results
None listed