ANZCTR search results

Approximately 20-30% of women with advanced breast cancer have a genetic alteration in the HER2 gene (human epidermal growth factor receptor-2), causing an over-expression of the HER2 protein in the tumour, which is associated with a more aggressive disease and a worse prognosis. Patients with this type of breast cancer benefit from treatment with Herceptin when the patient has not previously received chemotherapy for their advanced disease. This randomised clinical trial evaluates the use of Herceptin in combination with currently available chemotherapy treatments in providing a better outcome for these patients by delaying progression of the cancer and death with as little toxicity as possible. The trial will compare two treatments: (1) a combination of the drugs Taxotereâ, platinum salt and Herceptinâ and (2) a standard treatment of Taxotereâ and Herceptinâ in combination without platinum salt.

A greater proportion of people with osteoarthritis of the knee who complete the OAK Program will report minimal clinically important improvements in pain, knee function and quality of life, at 8 and 12 weeks, compared with those completing the generic ASMP course.

This study is being conducted in order to determine the proportion of HIV-1 patients attending Holdsworth House Medical Practice that may be susceptible to abacavir hypersensitivity reaction (HSR), which is associated with a genetic marker HLA-B*5701. Abacavir is a drug used in combination with other antiviral drugs, which is helpful in treating HIV infection. Abacavir is generally well tolerated, but 5-8% of patients develop an allergic reaction to the drug and the allergic reaction is much more common in those patients who have the genetic marker HLA-B*5701. Abacavir HSR is an allergic reaction characterised by respiratory and gastrointestinal symptoms that may be life threatening if abacavir dosing continues. Thus avoiding the use of abacavir in patients carrying this genetic marker will reduce the likelihood of developing a potentially serious allergic reaction. The study also aims to set up a model for a Registry where patient HLA-B*5701 results can be entered and made available to doctors who are licensed to prescribe HIV therapies in Australia via a secure password protected system. Ideally the Registry will be web-based, but if this is not feasible, it will be paper-based and managed by a recognised independent body already involved in the HIV field.

This randomised clinical trial will compare the combination of three cycles of chemotherapy (CMF) followed by tamoxifen versus tamoxifen alone in postmenopausal patients with node negative, oestrogen receptor positive breast cancer to determine which therapeutic strategy is better in terms of disease-free survival, overall survival and quality of life.

Background: 15,000 people are admitted to an Intensive Care Unit in Australia with severe sepsis every year. One third of these patients will die. Severe sepsis occurs when an infection causes dysfunction of one or more of the major organs (such as the heart or kidneys). A significant factor in this illness is that the body's normal response to infection or'inflammatory response' becomes abnormal. The statins are a class of medications commonly used in Australia to lower cholesterol. Previous research suggests that they may also have a beneficial effect on inflammation and that it may be harmful for people who are already taking statins to stop taking them if they develop severe sepsis. There is a lack of current information on the effects of these drugs in acute illness and the risks and benefits of continuing or starting treatment with them in patients with severe sepsis in the ICU. The aims of this project are: To assess the safety profile of atorvastatin in patients with severe sepsis To assess the effect of atorvastatin on inflammation and the outcome of patients with severe sepsis Research Design: A randomised controlled trial of atorvastatin 20mg versus placebo. Methods: Patients in the ICU with severe sepsis who meet the entry criteria will be given 20 mg of atorvastatin (a commerically available medication) or a placebo ("dummy drug"). The study drug will be given as a capsule by mouth or the contents will be given mixed with water via a feeding tube. Drug will be given once per day while the patient is in the ICU to a maximum of 28 days. Safety blood tests to look for signs of liver or muscle damage will be taken every day. Additional blood tests to assess inflammation will be taken 6 times during the study. All other care will be given as standard care.

Pilot studies show that spironolactone is effective in the arrest of female pattern hair loss and may result in some hair gain. However to date there have been no placebo controlled trials to verify this. As well minoxidil has been shown to be efficacious in the treatment of female pattern hair loss and there are recent case reports that it may have a synergistic effect when used with spironolactone. This project aims to study the effectiveness of these treatments as well as determining underlying tissue and genetic factors that may effect response.

The aim of the study is to test the effects of a couple based education program (Couple CARE for Parents) with couples having their first baby. We will assign couples to receive Couple CARE for Parents or usual woman focused education and support. We predict that Couple CARE for Parents will enhance couple relationship satisfaction, individual adjustment and parenting.

This clinical trial is for premenopausal and young postmenopausal women who after their breast cancer surgery have been found to have cancer cells in the glands of the armpit (‘positive axillary lymph nodes’) and whose tumours do not have oestrogen receptors (are not stimulated by oestrogen). These tumour characteristics are often associated with a higher risk for breast cancer recurrence. It is known that chemotherapy in standard doses after breast cancer surgery reduces the chance of breast cancer recurrence. However, this clinical trial aims to assess whether giving higher doses of chemotherapy is more effective in killing remaining cancer cells in women with a high risk of recurrence. Women will be allocated randomly (like the toss of a coin) to have either standard chemotherapy for their breast cancer, or high dose chemotherapy.

It is unclear whether patients who do not undergo an axillary dissection and receive further systemic treatment, have a similar prognosis to those with axillary clearance who receive the same therapy. The focus of this international trial is to determine the importance of an axillary node dissection for breast cancer patients 60 years or older who receive Tamoxifen as an ongoing treatment. Particular attention will also be given to the quality of life of the patients over the first six years of the study.

The use of tamoxifen has provided a reduction in deaths due to breast cancer in postmenopausal women with both node-positive and node-negative disease. However, the benefit of tamoxifen treatment may be confined to patients with oestrogen receptor positive disease and a standard adjuvant treatment for all postmenopausal patients with node-positive, oestrogen receptor negative disease has not yet been defined. Results from previous trials have indicated that the combination of CMF and tamoxifen (chemo-endocrine therapy) improved disease-free survival in all postmenopausal patients when compared with CMF or surgery alone. Patients with oestrogen receptor negative disease were found to benefit significantly from the combined treatments. Therefore, IBCSG VII will investigate the effectiveness of adding early combination chemotherapy and late additional chemotherapy to adjuvant tamoxifen compared to administering tamoxifen treatment alone in postmenopausal women.