• What are clinical trials
  • Trials open to new patients
  • New trials yet to be started
  • Trials in follow up phase
  • Local research
  • Relevant websites
What are clinical trials?

Clinical trials are a rigorous research method used to test and introduce new ways of detecting or screening, preventing or reducing risk and better options for treatment of breast cancer.

Clinical trials form the link between discoveries made in the cancer research laboratory and making new treatment available for people diagnosed with cancer. It is extremely important that all new therapies and procedures associated with any cancer care be accurately proven and long-term safety determined before they can be recommended for general or standard use.

What types of clinical trials are there for breast cancer?

Detection or screening trials evaluate the best approach to find a cancer in its early stages; for example mammograms (breast x-rays).

Prevention trials test new approaches; e.g. use of medicines or healthy lifestyle changes that may lower the risk of getting certain cancers.

Treatment trials test new treatment; e.g. drugs such as chemotherapy or hormonal treatments. New radiotherapy or surgical techniques are also tested. Counselling and psychological support or ways of providing better communication are also part of treatment trials.

Why participate in a trial?

Participation in a clinical trial does assist with the advancement of medical knowledge.

People take part in trials for a number of reasons. They may receive a new treatment before it is widely available to other cancer patients. Evidence shows people can also have better outcomes because they have been involved in a trial, even if they have received standard treatment.This may be because most participants on a clinical trial receive carefully and most often rigorously monitored treatment and follow-up.

Is a trial suitable for you?

Your Oncologist (Cancer Doctor or Specialist) may suggest that you consider taking part in a clinical trial, or if you are interested in taking part in a study but have not had this suggested, ask your Oncology Doctor.

They may be contributing to a suitable trial or know of one being done at another centre.

Your Oncology Doctor will explain a trial to you including the known benefits and risks of a new treatment or procedure. A patient information sheet giving the details of the research will also be given to you before you agree (consent) to take part in a trial.

Why are clinical trials important in breast cancer care?

All the major advances in controlling breast cancer have been the result of clinical trial research. This includes:

  • Our ability to use breast conserving surgery, instead of mastectomy (removal of the whole breast) for many women.
  • Saving lives with regular mammograms
  • The entry into the era of highly targeted therapies aimed at breast cancers which have specific features present, e.g. Herceptin for HER 2 positive breast cancer.
  • Improvements in radiotherapy and surgical techniques
  • Breast cancer prevention.

It is extremely important that all new therapies and procedures be scientifically proven and long term safety determined before they can be recommended for general or standard use.

Where are the participating centres for breast cancer trials in New Zealand?

In New Zealand, breast cancer clinical trials are available at Cancer Centres or Breast Clinics at North Shore, Auckland, Waikato, Palmerston North, Welllington, Christchurch and Dunedin Public Hospitals.

Some Cancer Specialists in private clinics participate in breast cancer clinical trials. Do ask your treating Oncology Doctor if there is a trial available for your situation.

“The most common thing women say regarding why they take part in a trial is “I want to help others, including my children”.

In my work as a surgeon I am moved by the courage and determination shown by women coping in the face of a breast cancer diagnosis. In addition to making treatment decisions at this time; including the shock and anxiety of the diagnoses; receiving a huge amount of information to consider, some women are offered participation in a clinical trial.

That means not only having to consider more options and information, but also having the very considerable courage to be allocated treatment by randomisation (or chance) not knowing whether the new strategy will be better or not.

It is thanks to many women around the world having this courage that we have made the progress we have to date in breast cancer treatment, and continue to do so.

The good news is that more lives than ever before are being saved from breast cancer and we are managing to do this with less disfiguring surgery, in addition to newer drug and radiation treatments.” Associate Professor Ian Campbell (Surgeon & WBCRT Chair)

Trials open to new patients

The POSNOC trial is a clinical research trial available in NZ looking at the armpit treatment provided to women diagnosed with early stage breast cancer. This UK based trial will involve 1900 women across the UK, Australia and NZ. Waikato, Rotorua and Palmerston North Hospitals will be centres for this research.

Protocol RD-5103-001-13: POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes or “POSNOC trial”

More information: Women with early breast cancer that has spread to one or two lymph glands will receive chemotherapy or endocrine therapy (hormone therapy), or both. These treatments are called adjuvant therapy. Drug treatments today are more advanced and very good at preventing breast cancer from coming back so radical armpit surgery (axillary dissection/clearance) may no longer be needed. If axillary dissection is no longer needed, it is important to know this. If we can avoid giving some women unnecessary treatment, then we can avoid long term side effects of treatments.

For further detail see http://www.posnoc.co.uk/

ROLLIS trial

Can Radio-guided Occult Lesion Localisation using Iodine-125 Seeds (ROLLIS) for excision of impalpable (not able to be felt) breast cancer reduce the rate of pathologically inadequate margins and/or subsequent oncological surgery compared with standard hook-wire localisation? A randomised controlled trial. This trial will involve 60 women from across the Greater Waikato region.

More information: Approximately one-third of breast cancers are non-palpable (i.e. not able to be felt). The success of breast cancer screening programmes has seen an increase in the number of women diagnosed with non-palpable breast cancers suitable for breast conserving surgery or “lumpectomy”. A tiny, slightly radioactive seed is placed within the breast cancer with imaging guidance by a Radiologist prior to surgery. The Surgeon then uses a hand-held radiation detector (gamma probe) in the operating theatre to find and remove the cancer and the seed. The ROLLIS technique is expected to enhance surgical planning and reduce re-operation rates compared to previous techniques.

This Australian and NZ trial has been made possible by grants from the Lion Foundation, Southern Trust and Grassroots Trust.

New trials yet to be started

EXamining PErsonalised Radiation Therapy for low-risk early breast cancer.

Protocol ANZ 1601/BIG 16-02: A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer of “EXPERT trial“

More information: The purpose of this study is to see whether a specialised laboratory test (Prosigna (PAM50) Assay) of breast cancer tissue can be used to choose women who can safely avoid radiation therapy because there is a low risk of the cancer coming back.

Lymph node grafting for breast cancer related lymphodema

Lymphoedema or swelling of the upper arm is a common and often distressing complication of breast cancer treatment. Current standard treatment involves massage techniques and the wearing of elastic compression sleeves. These are often awkward to fit and wear, unsightly and uncomfortable – particularly in the summer. They are also a daily reminder of breast cancer.

Reconstructive lymphatic microsurgery may be considered, if conservative standard lymphoedema treatment doesn’t help, but it is highly specialised and expensive. This randomised controlled trial will compare a novel surgical technique (lymph node grafting (LNG) in addition to standard lymphoedema therapy), against standard lymphoedema therapy alone. The aim is to determine whether LNG produces a greater reduction in lymphoedema volume and improved quality of life than standard treatment. A further aim is to demonstrate that lymph node grafting is a safe treatment.

More information: A pilot study of LNG headed by Mr Winston McEwan (Plastic Surgeon and Principal Researcher) has been carried out at Waikato Hospital over 2014 – 2016. The pilot study results showed this to be a safe and promising technique and should be investigated further in a larger clinical trial as an alternative to a microsurgical procedure for treatment of breast cancer related lymphoedema.

This clinical trial has been made possible by a grant from the Cancer Society of New Zealand, support for surgery from Braemar Hospital, Hamilton.

Trials in follow-up phase (not open to new patients)

a) Clinical trial for the prevention of breast cancer
The International Breast cancer Intervention Study II (IBIS II) is evaluating whether the drug anastrozole can prevent breast cancer in women at elevated risk (mostly due to a strong family history of breast cancer).

The Waikato is also a centre for the IBIS II bone sub-study, available for women participating in the IBIS II prevention study. This research evaluates the impact of anastrozole on bone health and whether the drug risedronate can prevent loss of bone density in these women.

We are also participating in the IBIS II mammographic breast density sub-study. Breast density is a known marker of increased risk for breast cancer.

b) Clinical trials and treatment of ductal carcinoma institute

IBIS II DCIS
There is a second part to the IBIS II trial where the use of anastrozole is being compared to tamoxifen for women with hormonally sensitive ductal carcinoma in situ (DCIS). DCIS is a non-invasive breast cancer.

ANZ Study 9008 DCIS
This Cancer Research UK coordinated study compares surgery alone with the addition of radiotherapy or Tamoxifen, or both, for the treatment of DCIS First results have shown that radiotherapy is important for most women who undergo breast conserving surgery for their DCIS.

c) Endocrine treatment for hormonally sensitive breast cancers

The Study Of Letrozole Extension (SOLE) trial.
Protocol IBCSG IBCSG 35-07/BIG 1-07 A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following four to six years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, and lymph node positive (for cancer) early stage breast cancer.
More information: The principle behind the intermittent use of letrozole is that stopping letrozole for three months will make any remaining cancer cells more sensitive to letrozole reintroduction.

The Suppression of Ovarian Function Trial (SOFT) is testing the role of ovarian function suppression and the role of exemestane in premenopausal women.

First results in 2014 showed that ovarian suppression reduces breast cancer recurrence for some young women.

d) Quality of life and breast reconstruction study
A prospective Quality of Life study of Immediate & Delayed (QoLid) breast reconstruction in women undergoing mastectomy and radiotherapy for breast cancer.
This study was made possible from grants from the Waikato Medical Research Foundation, Waikato Bay of Plenty Cancer Society and Jumble Around (Second hand store, Cambridge).

More information: Radiotherapy has a detrimental effect on outcomes from breast reconstruction for some women, especially for women undergoing implant based reconstruction. For this reason, some surgeons recommend delaying radiotherapy until after all of the therapy e.g. chemotherapy, is complete. This is a controversial issue with little good evidence to support the best approach.

The main aim of the study is to assess the quality of life and reconstruction outcomes from immediate & delayed breast reconstruction in women undergoing mastectomy and post-mastectomy radiotherapy for breast cancer. All recruited patients (immediate or delayed breast reconstruction or non-reconstructed patients) will be asked to complete questionnaires at set time frames throughout the study.

The questionnaires will assess quantitative & qualitative factors affecting quality of life throughout the treatment of their breast cancer and would assess whether breast reconstruction, timing of breast reconstruction, complications from surgery or adjuvant treatment regimes affect the patient’s overall quality of life.

This is a pilot study. Waikato Hospital is collaborating with the Royal North Shore Hospital and the Breast & Surgical Oncology Centre at The Poche Centre in North Sydney, in this first prospective study in Australia and New Zealand, assessing the quality of life of these women.

e) Sentinel node biopsy clinical trials
Sentinel Node biopsy versus Axillary Clearance Trial Part 2 (SNAC2). The initial SNAC Part 1 study, aimed to answer the question: “Does sentinel node biopsy (removal of the first lymph nodes related to the breast cancer, result in reduced side effects from surgery compared to standard axillary clearance?”. Part 2 of this research evaluates the use of sentinel node biopsy in women with larger breast cancers or with more than one cancer in the breast, to answer the very important question; “Does sentinel node biopsy result in increased local recurrence or decreased survival, and if so, for which group of women is this the case and for whom is axillary clearance really necessary? This is a Breast Surgeons Australia and New Zealand clinical trial.

The International Breast Cancer Study Group Study 23 is a clinical trial which aims to contribute to the question of appropriate management for women who have micro metastases (very tiny/microscopic deposits of cancer spread) found in the sentinel nodes. This research aims to answer the question of whether these women require axillary clearance or is it safe to manage these women without further surgery?

First results: At a median follow-up of five years there was no benefit seen for women undergoing axillary node dissection. Axillary dissection could be avoided in patients with early breast cancer and limited sentinel-node involvement, thus eliminating complications of axillary surgery with no adverse effect on survival. We await the eight-year follow-up data coming out later in 2017.

f) Radiotherapy trial
Selective Use of Postoperative Radiotherapy AftEr MastectOmy or SUPREMO trial.

More information: Radiotherapy is routinely given to women after mastectomy, when they are at “higher” risk of their breast cancer returning (e.g. when the tumour is large or when there is four or more lymph nodes involved by cancer). International controversy continues regarding which “moderate” risk group of women require radiotherapy after mastectomy and this international randomised trial is underway to attempt to further address this issue.

g) Use of prognostic laboratory tests

Trial Assigning Individualised Options for Treatment: The TAILORx Trial
This trial is investigating the Oncotype DX assay which is a prognostic laboratory test to predict breast cancer recurrence in women with early stage hormone receptor positive and node negative breast cancer. The aim of the research is to investigate whether women with an intermediate “recurrence score” (11-25) benefit from chemotherapy in addition to endocrine treatment.

First results of the TAILORx trial showed that the Oncotype DX test is able to reliably identify a subgroup of women with early stage, hormone receptor positive breast cancer who can safely avoid chemotherapy.

More information: link into ANZBCTG media release https://www.bcia.org.au/news-stories/250/genetic-test-identifies-which-early-stage-breast-cancer-patients-can-avoid-chemotherapy

Local research from the Waikato and other NZ Breast Cancer Registers

The WBCRT enables the Waikato Breast Cancer Register, which was established in 2005 with the intention of creating a population based picture of breast cancer care in the Waikato District Health Board region.

This confidential database allows multidisciplinary research into the many aspects of the breast cancer position in the Waikato and New Zealand. We collaborate with the Auckland, Wellington and Christchurch regional Breast Cancer Registers with observational studies and projects. In September 2017, we will transition to a web based New Zealand Breast Cancer Register. This extensive database will enable other regions to collaborate in defining the true incidence and nature of breast cancer; enable review of current patterns of care; and look to improve the outcomes for those who experience breast cancer.

PhD projects

i) The effects of comorbidity on breast cancer treatment and outcomes in New Zealand
Dr Mel Edwards (Doctoral Research Fellow, University of Auckland) commenced her PhD on this topic in January 2016. This involves investigating the management of women with breast cancer in addition to other medical problems and their ultimate outcomes. As this group of women are often under-represented in clinical trials and with complex medical needs it will be useful to determine where there may be opportunities to improve their care.

ii) A PhD project examining health literacy in Maori women with a view to interventions to see what can be done to help diagnose breast cancer at an earlier stage amongst Maori women. This project was commenced in 2015, with Tamati Peni, undertaking this work. Tamati worked with our breast cancer register team on the over 2012-2014 during which time he developed an indepth knowledge of the disease and many of the issues contributing to inequity in outcomes.

Tamati’s PhD project is supervised by Professor Ross Lawrenson, Professor of Population Health, University of Waikato and Clinical Director, Planning & Funding, Waikato District Health Board.

Post mastectomy recurrence study
This research is investigating post mastectomy recurrence and survival for Auckland and Waikato women with newly diagnosed breast cancer to try and determine: When is radiotherapy necessary?
This project is made possible by a grant from the NZ Breast Cancer Foundation. A/Professor Ian Campbell (Surgeon, Waikato District Health Board & WBCRT Chair) is heading this project).

When is enough, enough? Margins of excision after breast conservation surgery for breast cancer
This study seeks to determine what is the optimal margin of excision and how does this vary with tumour biology, patient factors, adjuvant therapy, and the other variables, many of which were not available in previous reported series. With this information, NZ and international clinicians can give more informed advice and make more informed decisions on this very common breast cancer treatment dilemma.
This project has been made possible by a grant from the NZ Health Research Council and NZ Breast Cancer Foundation joint initiative research grant. A/Professor Ian Campbell (Surgeon, Waikato District Health Board & WBCRT Chair) is heading this project).

Metastatic behaviour and outcomes of breast cancer subtypes
Among breast cancer patients who develop distant metastases, there is a marked variability in the clinical course, including pattern of metastatic spread. The project involves a retrospective observational study of breast cancer patients who developed distant metastases, focusing on the association between breast cancer subtype and clinical course, including organ-specific metastases.
Dr Marion Kuper-Hommel (Medical Oncologist, Waikato District Health Board & WBCRT Trustee) is heading this project.

Development and assessment of predictive models of outcome in breast cancer in New Zealand
The goal of this upcoming project is to identify factors related to breast cancer care outcomes for women in New Zealand, to assess existing predictive models, and to develop better predictive methods to assess prognosis. The outcome of breast cancer depends on many factors. If the prognosis of an individual patient can be predicted with some accuracy, this information is valuable to the treating doctor and the patient as it will impact on how they deal with the disease.
More information: This includes therapeutic choices; for example, a high proportion of patients with primary breast cancer meet eligibility criteria for adjuvant systemic therapy, but amongst this group are patients at very little risk of recurrence. It has been argued that in a substantial proportion of patients at lower risk, but treated according to current guidelines, the loss of quality of life from toxicity may outweigh the small or absent survival benefit. In contrast, patients at high risk may justify modified treatment or follow-up procedures.
This project is to be carried out by a PhD student (University of Auckland) under the supervision of Professor Mark Elwood (Professor of Cancer Epidemiology, University of Auckland).

Sentinel node study
This research is investigating the regional recurrence rate in patients undergoing sentinel node biopsy alone for breast cancer in NZ. It aims to identify tumour or sentinel node based factors that can help predict regional recurrence.

This project was made possible from a grant from the NZ Breast Cancer Foundation.

Some relevant websites for information on cancer clinical trials

Breast Cancer Trials Group: https://www.anzbctg.org/researchHome.aspx

International Breast Cancer Study Group: http://www.ibcsg.org/Pages/default.aspx

American National Cancer Institute: www.cancer.org

Cancer Research United Kingdom: https://www.cancerresearchuk.org/

The National Health and Medical Research Council Clinical Trials centre: https://www.nhmrc.gov.au

Australian New Zealand Clinical Trials Registry: http://www.breastcancertrials.org.au

Cancer Trials New Zealand: www.cancertrialsnz.ac.nz

Cancer Society of New Zealand: https://cancernz.org.nz/

Acknowledgements
We acknowledge the wider Breast Care Centre, Regional Cancer Centre and other Waikato Hospital Departmental multidisciplinary teams who support our research. We also acknowledge collaborators from the University of Auckland, the University of Waikato, Investigators from other District Health Board’s and colleagues from the Australia New Zealand Breast Cancer Trials Group.

We also acknowledge WBCRT Trustees, sponsors, grant organisations, and individuals who support our breast cancer research programme. There are many generous groups and people who make our research happen!

For further information on our research please contact:
Email: Jenni.Scarlet@waikatodhb.health.nz
Telephone: 07 8398726 Ext 97916