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Clinical trials position statement

Background

Clinical trials play a very important role in a research process to identify improved treatment options. Trials may take many years before new treatment options become part of standard breast cancer care.

Most of the major advances in breast cancer treatment have occurred because clinical trials first demonstrated the value of new treatments.

Some of these major advancements have resulted in tangible differences to the standard treatment of women with breast cancer. These include:

  • Demonstrating that breast conservation surgery is a safe alternative to mastectomy
  • Finding that the addition of chemotherapy and hormone therapy improves survival outcomes for women with some types of breast cancer
  • Finding that sentinel node biopsy is a good alternative to removing all the underarm nodes (axillary dissection)
  • Introducing Herceptin as a powerful treatment for HER2 positive breast cancer.

Many new clinical trials are currently underway.  Examples include:

  • The SORBET trial, which is investigating whether tamoxifen is a good treatment for women with a particular type of triple negative breast cancer.
  • The EMILIA, MARIANNE and TH3RESA studies, which are investigating whether a new type drug, called TDM-1, is as effective against HER2 positive breast cancer as standard treatment.
  • The TARGIT trials, which are investigating the use of intraoperative radiotherapy as an alternative to external beam radiotherapy.

BCNA’s Position Statement

Consumer Involvement

Trained and supported consumer representatives should be engaged at every step of the research process, including:

  • design of trials
  • development of protocols
  • preparation of informed consent material
  • monitoring and reporting of trials.

Information

All clinical trial information to be circulated to women should be written in clear English and should not include complex concepts and jargon.

Women who decide to participate in clinical trials should feel well informed about their participation. This information includes, but is not limited to:

  • patient participation information
  • informed consent forms and material
  • any information about the scientific methodology, including trial outcomes

Women involved in a clinical trial should be kept informed about the progress of the trial and any results that may influence their ongoing participation.

Trial results should be published whether they are favourable or unfavourable.

Access and Choice

Those establishing clinical trials should consider access issues for women living in rural and remote areas so they are not disadvantaged in participating.

The choice of whether or not to participate in a clinical trial is a personal one. The standard of care should not be affected by a decision to participate or not in a clinical trial.

All women should be able to opt out of clinical trials at any time for whatever reason without their future treatment options being affected by their decision.

The National Health and Medical Research Council should continue to fund the Australian Clinical Trials Registry (ACTR). The ACTR should be further developed with a view to ensure that it is easily accessed, used and understood by clinical trial participants.

More information

  • Our section on clinical trials will provide more information including a link to our clinical trials fact sheet.
  • The Australian Clinical Trials Registry is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere.
  • Cancer Australia’s Consumer Learning website provides learning and support initiatives to assist consumers in partnering with researchers to conduct good quality patient-centred clinical trials.