Effect of chemotherapy and growth factor on cancer and stem cells in blood.

Phase 2

Recruiting

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12607000221459
• Lead Sponsor: Department of Medical Oncology, Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the peak and duration of CD34+ progenitor cells in peripheral blood after a single dose of pegfilgrastim and docetaxel analysed on blood samples collected between D4-D11 and D21.[Analysed on the same day as blood is collected.];2. To study the peak and duration of CTCs (circulating tumor cells) in peripheral blood after a single dose of pegfilgrastim and docetaxel analysed on blood samples collected between D4-D11 and D21.[Analysed on the same day as blood is collected.]

Secondary Outcome Measures

Name	Time	Method
1. To study relation between CD34+ progenitor cells and CTCs at different time points on the blood sample collected on D4-D11 and D21.[The secondary outcomes will be analysed on the same day as blood is collected.];2. To estimate difference between baseline and peak CD34+ progenitor cells and CTCs on the blood sample collected on D4-D11 and D21.[The secondary outcomes will be analysed on the same day as blood is collected.];3. To study up regulation or down regulation of various cell surface receptors including CXCR4 on the blood sample collected on D4-D11 and D21.[The secondary outcomes will be analysed on the same day as blood is collected.]