• The importance of research
  • Latest research findings
  • Current research being undertaken
  • What are clinical trials
  • Trials open to new patients
  • New trials yet to be started
  • Trials in follow up phase
  • Relevant websites

Research is ongoing, it never stops in the drive to prevent and cure breast cancer.

Breast cancer is not just one disease; there are many types and stages all of which need different treatments. That is why we cannot rest on our laurels, and why we must continue to drive our research efforts to achieve the best – the best outcomes, the best preventative measures, the best cure.

The Waikato Breast Cancer Research Trust engages in local and international breast cancer research trials to ensure wāhine/women receive the very best treatment for the type of breast cancer they are suffering from. Women participating in good quality cancer trials, on average, do better in responding to treatment, yet only a minority have this opportunity.

Through good quality research and the contribution of wāhine/women, research staff, scientists and clinicians, steady advances have been made in breast cancer care. These advances have resulted in improved chances of a good outcome for women diagnosed with the disease.

Major advances in controlling breast cancer include:

  • our ability to use breast conserving surgery or less radical mastectomy (removal of the whole breast) for many wāhine/women
  • saving lives with regular mammography screening
  • better drug treatments, both chemotherapy and hormonal therapies
  • the entry into the era of highly targeted therapies aimed at breast cancers which have specific features present e.g. Herceptin for HER2 positive breast cancer
  • reducing local recurrence with improvements in radiotherapy
  • developments of breast reconstruction and sentinel node surgical techniques
  • breast cancer prevention

 

Treatment and survival of Asian women diagnosed with breast cancer in New Zealand

Chunhuan Lao, Ross Lawrenson, Melissa Edwards and Ian Campbell

Purpose
This study aims to examine the differences in characteristics, treatment and survival between Asian and European women diagnosed with stage I–III breast cancer in New Zealand.

Methods
The studied population included European women and Asian women diagnosed with stage I–III breast cancer between June 2000 and May 2013 identified from the combined Waikato and Auckland Breast Cancer Registers. Characteristics and treatment were compared between Asian and European women. Kaplan–Meier method was used to examine the
survival difference. Cox proportional hazards model was used to estimate the hazard ratio (HR) of mortality.

Results
The studied cohort included 8608 European and 949 Asian women. Asian women were younger, had less comorbidities and were less likely to be obese than European women. Asian women were more likely to have grade 3, larger and HER2+ breast cancers. Asian women were more likely to receive mastectomy, less likely to have reconstruction after mastectomy, less likely to have chemotherapy, less likely to be treated with trastuzumab if HER2+, and had better adherence to endocrine therapy (adjusted odds ratio: 1.54; 95% CI 1.22–1.93). Asian women had better cancer-specific survival and all-cause survival than European women. The adjusted HR of cancer-specific mortality and all-cause mortality were 0.64 (95% CI 0.49–0.82) and 0.68 (95% CI 0.55–0.84), respectively.

Conclusions
Asian women are more likely to have high grade, larger and HER2+ breast cancers than European women. In spite of this, they had better breast cancer outcomes. Possible explanations include the differences in adherence to endocrine therapy, age, BMI and comorbidities.

 

Outcomes in different ethnic groups of New Zealand patients with screen-detected vs. non-screen detected breast cancer.

Ross Lawrenson, Chunhuan Lao, Gregory Jacobson, Sanjeewa Seneviratne, Nina Scott, Diana Sarfati, Mark Elwood and Ian Campbell

Objective
To compare characteristics and survival of New Zealand European, Māori, and Pacific women with screen-detected vs. non-screen-detected breast cancer.

Methods
Women aged 45-69 diagnosed with invasive breast cancer between January 2005 and May 2013 were identified from the Waikato and Auckland Breast Cancer Registries. Patient demographics and tumour characteristics were described by detection mode and ethnicity. Kaplan-Meier method was used to estimate the five-year breast cancer-specific survival of women with stage I-III breast cancer by ethnicity and detection mode.

Results
Women with screen-detected cancers were older, had smaller tumours, fewer stage IV (0.8% vs. 7.6%), fewer high grade (16.8% vs. 39.0%), and fewer lymph node positive diseases (26.3% vs. 51.5%) than women with non-screen-detected cancers. There were more Luminal A (70.0% vs. 54.0%), fewer human epidermal growth factor receptor 2 positive non-Luminal (4.4% vs. 8.8%), and fewer triple negative cases (7.0% vs. 13.8%) in screen-detected than non-screen-detected cancers. If not screen detected, 22.7% of breast cancers in Pacific women were stage IV compared with 2.4% if screen detected. If not screen detected, the five-year breast cancer-specific survival was 91.1% for New Zealand European women, 84.2% for Māori women, and 80.2% for Pacific women (p-value <0.001). For screen-detected breast cancer, survival between different ethnic groups was similar.

Conclusions
Breast cancers detected through screening are diagnosed at an earlier stage and have a greater proportion of subtypes, with better outcome. Variations in survival for Māori and Pacific women are only found in women with non-screen-detected breast cancer.

 

The impact of different tumor subtypes on management and survival of New Zealand women with Stage I-III breast cancer.

Ross Lawrenson, Chunhuan Lao, Ian Campbell, Vernon Harvey, Sanjeewa Seneviratne, Mark Elwood, Diana Sarfati, Marion Kuper-Hommel

Aims
This study aims to describe the prevalence and characteristics of the different ER/PR/HER2 subtypes in New Zealand women with breast cancer, and to explore their treatment and outcomes.

Methods
This study included women diagnosed with Stage I–III breast cancer between January 2006 and May 2013, recorded in the combined Waikato and Auckland Breast Cancer Registers, and with complete data on their ER, PR and HER2 status. Five ER/PR/HER2 phenotypes were classified. Kaplan-Meier method and Cox proportional hazards model were used to examine the survival differences among these subtypes.

Results
Of the 6,875 eligible women, 4,274 (62.2%) were classified as Luminal A, 836 (12.2%) as Luminal B HER2-, 605 (8.8%) as Luminal B HER2+, 401 (5.8%) as HER2+ non-Luminal and 759 (11.0%) as Triple Negative. Maori and Pacific women were less likely to have Triple Negative disease, while Pacific women were more likely to be HER2+ non-Luminal. The five-year breast cancer-specific survival was worst for HER2+ non-Luminal (80.1%) and Triple Negative (81.9%), followed by Luminal B HER2- (89.3%) and Luminal B HER2+ (91.6%), and was the best for Luminal A (96.8%). The adjusted breast cancer-specific mortality hazard ratio for Triple Negative and HER2+ non-Luminal compared to Luminal A was 4.91 (95% CI: .86–6.26) and 3.94 (95% CI: 2.94–5.30), respectively.

Conclusions
The pattern of phenotype in women with Stage I-III breast cancer is  similar to the overseas cohorts. Most New Zealand women with Luminal A breast cancer have a very good prognosis, but the less common subtypes have relatively poor outcomes.

 

Surgical treatment of early stage breast cancer in Auckland and Waikato regions of New Zealand

Ian Campbell, Chunhuan Lao, Tania Blackmore, Melissa Edwards, Louise Hayes, Alex Ng and Ross Lawrenson

Background
The aim of this study was to understand the factors influencing the use of surgical options by New Zealand wāhine/women with newly diagnosed breast cancer.

Methods
Using data from the Auckland and Waikato breast cancer registers, 11, 798 women diagnosed with stage I-III breast cancer from June 2000 to May 2013 were included. The characteristics of women receiving different surgical treatments and having immediate breast reconstruction following mastectomy were examined. A logistic regression was used to estimate the odds ratio of having breast-conserving surgery (BCS) versus mastectomy and immediate post-mastectomy reconstruction. Bilateral breast cancer cases and women with unilateral breast cancer, but who had bilateral surgery, were also identified.

Results
Fifty‐two percent of women received BCS and 44% had mastectomy over the study period. Key influences associated with BCS were age, mode of diagnosis, socio‐economic status and public or private treatment. Just under half of the women who underwent bilateral surgery did not have bilateral cancer. Nineteen percent of women undergoing mastectomy underwent immediate reconstruction. Implant use increased slightly over the study period but there was a decrease in the use of autologous flap procedures.

Conclusion
Surgical management of women with localized breast cancer was generally in line with guidelines, but with potential to further increase the use of breast conservation and immediate reconstruction in suitable cases.

 

Development and validation of a new predictive model for breast cancer survival in New Zealand and comparison to the Nottingham prognostic index

Mark Elwood, Essa Tawfiq, Sandar Tin Tin, Roger J. Marshall, Tung M. Phung, Ian Campbell, Vernon Harvey and Ross Lawrenson

Background
The only available predictive models for the outcome of breast cancer patients in New Zealand (NZ) are based on data in other countries. We aimed to develop and validate a predictive model using NZ data for this population, and compare its performance to a widely used overseas model, the Nottingham Prognostic Index (NPI).

Methods
We developed a model to predict 10-year breast cancer-specific survival, using data collected prospectively in the largest population-based regional breast cancer registry in NZ (Auckland, 9182 patients), and assessed its performance in this data set (internal validation) and in an independent NZ population-based series of 2625 patients in Waikato (external validation). The data included all women with primary invasive breast cancer diagnosed from 1 June 2000 to 30 June 2014, with follow up to death or Dec 31, 2014. We used multivariate Cox proportional hazards regression to assess predictors and to calculate predicted 10-year breast cancer mortality, and therefore survival, probability for each patient. We assessed observed survival by the Kaplan Meier method. We assessed discrimination by the C statistic, and calibration by comparing predicted and observed survival rates for patients in 10 groups ordered by predicted 10-year survival. We compared this NZ model with the Nottingham Prognostic Index (NPI) in this validation data set.

Results
Discrimination was good: C statistics were 0.84 for internal validity and 0.83 for an independent external validity. For calibration, for both internal and external validity the predicted 10-year survival probabilities in all groups of patients, ordered by predicted survival, were within the 95%  confidence intervals (CI) of the observed Kaplan-Meier survival  probabilities. The NZ model showed good discrimination even within the prognostic groups defined by the NPI.

Conclusions
These results for the New Zealand model show good internal and external validity, transportability, and potential clinical value of the model, and its clear superiority over the NPI. Further research is needed to assess other potential predictors, to assess the model’s performance in specific subgroups of patients, and to compare it to other models, which have been developed in other countries and have not yet been tested in NZ.

 

Receipt of radiotherapy after mastectomy in women with breast cancer: Population-based cohart study in New Zealand

Phyu Mon Latt, Sandar Tin Tin, Mark Elwood, Ross Lawrenson and Ian Campbell

Purpose
To investigate the receipt of postmastectomy radiotherapy (PMRT) in breast cancer patients in New Zealand for whom radiotherapy is strongly recommended in current clinical guidelines.

Method
This study involved all women who were diagnosed with primary invasive breast cancer in two health regions, had undergone a mastectomy, and met the ‘strong recommendation’ criteria for PMRT based on New Zealand National Guidelines. We performed logistic regression analyses to identify demographic and clinical factors associated with the receipt of PMRT.

Results
Of the 1,455 patients with stage II to III cancers included in this analysis, 1195 (82%) received radiotherapy. The receipt of PMRT decreased with increasing age, and was significantly lower in rural residents, Māori and Pacific women, those with more comorbidity, those who receive primary cancer care in the a public facility, and those diagnosed with stage III cancer. Although not significant, the receipt was also lower in patients who resided in more deprived neighborhood, and those with comorbidities. The findings restricted to stage III patients (n = 1325), and to those diagnosed since 2010 (n = 422), after the current guidelines were published, which were very similar to the whole cohort.

Conclusion
Disparities exist in the receipt of PMRT in breast cancer patients in New Zealand, underscoring the need for a greater equity focus in management of breast cancer.

 

Impact of radiotherapy on cardiovascular health of women with breast cancer

Ross Lawrenson, Chunhuan Lao, Ahmed Ali and Ian Campbell

Introduction
This study aims to examine the impact of radiotherapy on the cardiovascular health of women diagnosed with breast cancer in the Waikato region in New Zealand.

Methods
Women diagnosed with stage 0–III breast cancer and recorded in the Waikato Breast Cancer Registry were divided into two groups: a radiotherapy group and a no-radiotherapy group. Baseline characteristics and treatments were compared in the two groups. Kaplan–Meier survival analysis was performed to compare cardiovascular morbidity and mortality. Cox Proportional Hazard regression analysis was used to estimate the hazard ratio of radiotherapy on the risk of cardiovascular morbidity and mortality while adjusting for other factors.

Results
A total of 3528 women were included in this study, with 2303 in the radiotherapy group and 1225 in the no-radiotherapy group. At 10-year followup, 11.7% of women in the radiotherapy group and 19.4% in the no-radiotherapy group experienced cardiovascular events. Only 2.3% of patients who received radiotherapy died of cardiovascular disease by 10  years compared to 7.0% in the no-radiotherapy group. After adjusting for clinically significant factors, there was unexplained reduced risk of developing cardiovascular disease in the radiotherapy group compared to the no-radiotherapy group (HR 0.73, 95% CI: 0.59–0.92). No significant difference was found in cardiovascular mortality between the two groups.

Conclusions
Radiotherapy appears less likely to be offered to patients at higher risk of cardiovascular disease. No evidence of increased risk of a cardiovascular event was found in the group of women with breast cancer treated with radiotherapy and current regimens appear safe. Traditional cardiovascular risk factors remain the main culprits in this setting. Clinicians should work with patients in managing these risk factors for optimal results.

 

Ethnic disparities in breast cancer survival in New Zealand: which factors contribute?

Sandar Tin Tin, Mark Elwood, Charis Brown, Diana Sarfati, Ian Campbell, Nina Scott, Reena Ramsaroop, Sanjeewa Seneviratne, Vernon Harvey and Ross Lawrenson

Background
New Zealand has major ethnic disparities in breast cancer survival with Māori (indigenous people) and Pacific women (immigrants or descended from immigrants from Pacific Islands) faring much worse than other ethnic groups. This paper identified underlying factors and assessed their relative contribution to this risk differential.

Methods
This study involved all women who were diagnosed with primary invasive  breast cancer in two health regions, covering about 40% of the national population, between January 2000 and June 2014. Māori and Pacific patients were compared with other ethnic groups in terms of demographics, mode of diagnosis, disease factors and treatment factors. Cox regression modelling was performed with stepwise adjustments, and hazards of excess mortality from breast cancer for Māori and Pacific patients were assessed.

Results
Of the 13,657 patients who were included in this analysis, 1281 (9.4%) were Māori, and 897 (6.6%) were Pacific women. Compared to other ethnic groups, they were younger, more likely to reside in deprived neighbourhoods and to have co-morbidities, and less likely to be  diagnosed through screening and with early stage cancer, to be treated in a private care facility, to receive timely cancer treatment, and to receive breast conserving surgery. They had a higher risk of excess mortality from breast cancer (age and year of diagnosis adjusted hazard ratio: 1.76; 95% CI: 1.51–2.04 for Māori and 1.97; 95% CI: 1.67–2.32 for Pacific women), of which 75% and 99% respectively were explained by baseline differences. The most important contributor was late stage at diagnosis. Other contributors included neighbourhood deprivation, mode of diagnosis, type of health care facility where primary cancer treatment was undertaken and type of loco-regional therapy.

Conclusions
Late diagnosis, deprivation and differential access to and quality of cancer care services were the key contributors to ethnic disparities in breast cancer survival in New Zealand. Our findings underscore the need for a greater equity focus along the breast cancer care pathway, with an emphasis on improving access to early diagnosis for Māori and Pacific women.

 

Obesity and breast cancer outcomes in chemotherapy patients in New Zealand – a population-based cohort study

Mark Elwood, Sandar Tin Tin, Marion Kuper-Hommel, Ross Lawrenson and Ian Campbell

Background
Obesity has been reported as an adverse prognostic factor in breast cancer, but inconsistently, and under-treatment with chemotherapy may occur. We provide the first assessment of obesity and breast cancer outcomes in a population-based, multi-ethnic cohort of New Zealand patients treated with chemotherapy.

Methods
All 3536 women diagnosed with invasive breast cancer in the Waikato region of New Zealand from 2000-2014 were registered and followed until last follow-up in specialist or primary care, death or Dec 2014; median follow-up 4.1 years. For the 1049 patients receiving chemotherapy,  mortality from breast cancer, other causes, and all causes, and rates of loco-regional and of distant recurrence, were assessed by body mass index (BMI), recorded after diagnosis, adjusting for other clinico-pathological and demographic factors by Cox regression.

Results
BMI was known for 98% (n=1049); 33% were overweight (BMI 25-29.9), 21% were obese (BMI 30-34.9), and 14% were very obese (BMI 35+). There were no significant associations between obesity and survival, after adjustment for demographic and clinical factors (hazard ratios, HR, for very obese compared to BMI 21-24, for breast cancer deaths 0.96 (0.56-1.67), and for all deaths 1.03 (0.63-1.67), respectively, and only small non-significant associations for loco-regional or metastatic recurrence rates (HR 1.17 and 1.33 respectively). Subgroup analyses by age, menopausal status, ethnicity, stage, post-surgical radiotherapy, mode of diagnosis, type of surgery, and receptor status, showed no associations. No associations were seen with BMI as a continuous variable. The results in all patients irrespective of treatment but with recorded BMI data (n=2296) showed similar results.

Conclusions
In this population, obesity assessed post-diagnosis had no effect on survival or recurrence, based on 1049 patients with chemotherapy treatment with follow-up up to 14 years.

 

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 wāhine/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.

A PhD project examining health literacy in Māori wāhine

With a view to interventions to see what can be done to help diagnose breast cancer at an earlier stage amongst Māori wāhine. 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 wāhine/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. Associate 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 wāhine/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.

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.

What are clinical trials?

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 that they may be contributing to or know of one being done at another centre.

If you are interested in taking part in a study ask your Oncology Doctor.

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.

POSNOC

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.

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”.

Wāhine/women with early breast cancer that has spread to one or two lymph glands receive chemotherapy or endocrine therapy (hormone therapy), or both. These treatments are called adjuvant therapy.

Alongside adjuvant therapy some wāhine/women also have axillary dissection/clearance (radical armpit surgeries). With the advancement of drug treatments that are very good at preventing breast cancer reoccurring axillary dissection/clearance may no longer be needed.

The POSNOC trial will help determine if axillary dissection is no longer needed meaning that some wāhine/women will be able to avoid unnecessary treatment and long term side effects of treatments.

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.

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

 

EXPERT

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“

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 wāhine/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.

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.

There are no trials yet to be started currently.

The International Breast Cancer Intervention Study II

The International Breast cancer Intervention Study II (IBIS II) is evaluating whether the drug anastrozole can prevent breast cancer in wāhine/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 wāhine/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.

 

IBIS II DCIS

There is a second part to the IBIS II trial where the use of anastrozole is being compared to tamoxifen for wāhine/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 wāhine/women who undergo breast conserving surgery for their DCIS.

 

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 wāhine/women with hormone-receptor positive, and lymph node positive (for cancer) early stage breast cancer.

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)

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

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

 

Quality of life and breast reconstruction study (QoLid)

A prospective Quality of Life study of Immediate & Delayed (QoLid) breast reconstruction in women undergoing mastectomy and radiotherapy for breast cancer.

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.

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).

 

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 wāhine/women from across the Greater Waikato region.

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 wāhine/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.

Sentinel node biopsy clinical trials (SNAC2)

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.

 

International Breast Cancer Study Group Study

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.

 

Selective Use of Postoperative Radiotherapy AftEr MastectOmy or SUPREMO trial.

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.

 

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.

https://www.bcia.org.au/news-stories/250/genetic-test-identifies-which-early-stage-breast-cancer-patients-can-avoid-chemotherapy

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