None listed
Conditions
Brief summary
Preliminary studies indicated that docetaxel and doxorubicin work well in patients with incurable breast cancer. The doses used in this study were based on earlier phase I studies. Phase II studies had been done to assess the effect of the combination of docetaxel and doxorubicin. This combination was found to work well in patients with metastatic or incurable breast cancer. This study will allowed us to use both drugs in a different way - that is, before surgery and in patients with locally advanced breast cancer (where the cancer has not spread anywhere else). By doing the study, we hoped to provide better local treatment and better cure rates. This had not yet been proven in earlier studies.
Interventions
Locally advanced breast cancer diagnosis was confirmed by fine needle aspirate or core biopsy as well as multidisciplinary assessment by any two out three disciplines - surgeon, medical oncologist or radiation oncologist prior to study entry. After 6 cycles of chemotherapy, surgical assessment was performed and mastectomy recommended. Following this, radiotherapy and tamoxifen were strongly recommended and constituted part of the study protocol. Chemotherapy was given for six cycles every 21 day
Locally advanced breast cancer diagnosis was confirmed by fine needle aspirate or core biopsy as well as multidisciplinary assessment by any two out three disciplines - surgeon, medical oncologist or radiation oncologist prior to study entry. After 6 cycles of chemotherapy, surgical assessment was performed and mastectomy recommended. Following this, radiotherapy and tamoxifen were strongly recommended and constituted part of the study protocol. Chemotherapy was given for six cycles every 21 days - doxorubicin 50 mg/m2 followed one hour later by docetaxel 75 mg/m2 . Steroid administration consisted of six oral doses of dexamethasone 8mg. Chemotherapy was ceased if disease remained static for three cycles, if progression occurred. Neutropenia was managed by the prophylactic use of G-CSF. Subcutaneous injections commenced 24 – 48 hours after the completion of each cycle of chemotherapy and continued for seven days or until neutrophil recovery (> 1.5 x 109/L). Quality of life was assessed at baseline, cycles 2 and 4 before chemotherapy was given, and then at months 5, 9, 12, 18 and 24.
Sponsors
The Cancer Council Victoria
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pre and post menopausal women with histologically proven locally advanced breast cancer as assessed by at least two clinicians ie surgeon &/or medical oncologist &/or radiation oncologist (UICC guidelines disease ranging between T3 and N2 to T4c and N1)2. Diagnosis of invasive adenocarcinoma is confirmed by core biopsy. A fine needle aspirate is acceptable but not encouraged3. Axillary lymph nodes clinically examined and may contain invasive tumour; may be fixed to one another or other structures4. The determination of oestrogen (ER) and progresterone (PgR) receptors is mandatory and results must be known by the end of chemotherapy to determine if hormonal therapy is indicated. ER and/or PgR are considered positive if > or = 1% of cells stain positively regardless of staining intensity, using immunohistochemistry5. All subjects should be evaluated at baseline and negative for distal and regional metastatic disease6. All subjects must be fit for and agree in principle to mastectomy and axillary dissection prior to study entry7. Subjects must be < or = 70 yrs of age8. Adequate renal and liver function and blood counts9.Left ventricular efection fraction (LVEF) must be normal (>50%) and electrocardiography (ECG) must not preclude anthracycline use.10.The subject must be able to give written informed consent according to the rules at each institution. The human rights Declaration of Helsinki must be the basis for the inclusion of patients.
Outcome results
None listed