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Clinical Trial Findings

Short title “ROLLIS Trial”. Can the use of low dose radioactive seeds to guide surgical removal of small areas of abnormal breast tissue reduce the rate of second operation compared with standard hook-wire technique? (ROLLIS RCT: Radio-guided Occult Lesion Localisation using Iodine125 Seeds).

Commenced 2016 – completed 2021

Purpose

To investigate an alternative method of marking nonpalpable breast cancers to guide surgery.

Phase 4 – An international field study of the reliability and validity of an EORTC breast reconstruction questionnaire to assess quality of life in all types of breast reconstruction.

Commenced 2014 - completed 2018

Purpose

In association with the Quality of Life Group (QLG) of the European Organisation for Research into Treatment of Cancer (EORTC), the purpose of this study was to develop a measure, which could be used in the future to investigate the quality of life of women undergoing or having undergone different types of breast reconstruction.

Anastrozole for breast cancer prevention – taking anastrozole for reducing breast cancer risk in women at high risk for breast cancer (International Breast cancer Intervention Study Part 2 or “IBIS II”)

Commenced 2007 and completed 2021

Purpose

Evaluating whether the drug anastrozole can prevent breast cancer in women at elevated risk.

Quality of life and breast reconstruction study

Commenced 2014 and completed 2021

Purpose

To investigate the quality of life of women who have chosen to have immediate or delayed breast reconstruction, or no breast reconstruction, after mastectomy and before having radiotherapy, for breast cancer.

Study drug (GDC-0941) with Fulvestrant versus Fulvestrant alone in advanced or metastatic breast cancer (short title “FERGI" trial)

Commenced 2012 – completed 2018

Purpose

The purpose of this study is to find out what effects, good and/or bad, GDC-0941 has on metastatic breast cancer when given to you in combination with another drug, called fulvestrant. GDC-0941 (Pictilisib) is a study drug that inhibits a protein called PI3‑kinase that may be involved in the growth and spread of some cancers. In animal studies and laboratory experiments, GDC-0941 (Pictilisib) has been shown to prevent or slow the growth of many different types of human cancer cells.  The study drug is currently being tested in clinical studies in people with advanced cancer. Metastatic breast cancer remains an incurable disease despite a number of more effective treatments.

The Cognitive Function Sub-study to the Suppression of Ovarian Function Trial (SOFT)

Commenced 2008 – completed 2016

Purpose

The parent SOFT (see trials in follow-up) was done to see if suppressing ovarian function, plus giving tamoxifen or exemestane is better at preventing the return of breast cancer than giving tamoxifen alone in premenopausal/younger women. The cognitive function sub-study evaluated the effects of these hormone treatments on memory and thinking (cognitive function).

ANZ 0501 LATER TRIAL (Later Adjuvant aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer.)

Commenced 2010 and completed 2016

Purpose

This trial is finding out whether taking the drug letrozole a year or more after finishing five years of treatment with hormonal therapy (e.g. tamoxifen); can prevent or delay breast cancer recurring in post-menopausal women.

SNAC2 Decision Aid Study

Commenced 2009 – completed 2015

Purpose

The purpose of this study is to evaluate the usefulness of a decision aid booklet to assist women who are considering participation in the Sentinel Node biopsy versus Axillary Clearance Part 2 trial. Note the above SNAC 1 trial introduced sentinel node biopsy to women with small and unifocal (one focus) breast cancer. SNAC2 (see trials in follow-up) is investigating sentinel node biopsy for larger and/or multifocal (more than one) breast cancer.

Study of Letrozole Extension (SOLE) trial

Commenced 2008 – completed 2018

Purpose

The SOLE trial aimed to find out if taking letrozole intermittently was better than taking it continuously.

Femara versus Anastrozole Clinical Evaluation (FACE) trial

Commenced 2006 – completed 2016

Purpose

This Novartis Pharmaceuticals sponsored clinical trial looked at whether there is a difference between letrozole (femara) and anastrozole when treating early breast cancer.

International breast cancer study group (IBCSG) study 23

Commenced 2006 - completed 2018

Purpose

To answer the question of appropriate management for women who have micrometastases (very tiny/microscopic deposits (< 2mm) 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?

A cross-sectional study to evaluate the local incidence of lymphoedema and sensory changes following surgery for breast cancer.

Commenced 2004 – completed 2012

Purpose

The main purpose of this study was to assess the Waikato incidence of lymphoedema in patients who had undergone axillary node dissection and how the individual symptoms described by patients compare with measurements (using a tape measure) of arm circumferences. Other aims of this Waikato study were to investigate the relationship between risk factors and the incidence of lymphoedema and to establish an easy and convenient way to detect lymphoedema in patients seen in surgical clinics.

To Infiltrate or Not? Local Anaesthetic in Breast Surgery

Commenced 2005 - completed 2013

Purpose

This Waikato prospective, randomised, single-blind study aimed to determine whether wound infiltration of local anaesthetic decreases postoperative pain and analgesic use, without increasing postoperative complications in breast surgery.

Communication about clinical trials and treatment options: A randomised controlled trial of a consultation skills training package.

Commenced 2004 – completed 2009

Purpose

This research looked at the communication of treatment options and the evaluation of a communication training programme for doctors.

The use of zoledronic acid for the prevention of bone loss in women receiving letrozole (short title “Zometa trial”)

Commenced 2004 – completed 2013

Purpose

This study examined the use of Zoledronic acid (also called Zoledronate) in the prevention of cancer treatment-induced bone loss in postmenopausal women receiving letrozole as adjuvant therapy for early breast cancer.

Sentinel node biopsy versus axillary clearance part 1 (SNAC 1)

Commenced 2002 – completed 2016

Purpose

This study investigated whether sentinel node biopsy resulted in less morbidity (side effects) than immediate axillary clearance and whether this lesser surgery to the armpit had equivalent cancer-related outcomes in women with early breast cancer.

BIG 1-98/IBCSG18-98: Adjuvant Letrozole trial. A phase III study to evaluate Letrozole as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive tumours.

Commenced 2001 – completed 2015

Purpose

Should either tamoxifen or letrozole be used alone for five years (daily) or should they be used in sequence (one followed by the other), and should tamoxifen or letrozole be given first.

IBCSG 21-99/NCCTG N9431: Menstrual Cycle and surgical treatment of breast cancer

Commenced 2001 – completed 2012

Purpose

This American coordinated study evaluated whether the timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome, that is, the likelihood of recurrence of her breast cancer or death.

Arimidex (anastrozole), Tamoxifen alone or in Combination (ATAC) trial

Commenced 1998 – completed 2010

Purpose

This international trial investigated which was the best treatment; Arimidex (anastrozole) alone, tamoxifen alone or anastrozole and tamoxifen in combination (taken daily over five years).

Tamoxifen for breast cancer prevention

Commenced 1997 and completed 2014

Purpose

This UK coordinated breast cancer prevention study investigated whether the breast cancer drug tamoxifen is effective in reducing the incidence of breast cancer in women at high risk for breast cancer (mostly due to a strong family history).

BIG 2-97/IBCSG 16-98: Intergroup Exemestane Study. A randomised double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen.

Commenced 1998 – completed 2013

Purpose

This trial compared five years of tamoxifen with two-three years tamoxifen followed by the aromatase inhibitor exemestane.

IBCSG 17-98/BIG 3-97 HABITS – A randomised clinical trial concerning hormonal replacement therapy (HRT) after previous radical breast cancer treatment. Short title: Hormone replacement therapy After Breast cancer is IT Safe?

Commenced 1999 – completed 2014

Purpose

This trial evaluated the safety of a short course of hormone replacement therapy in women with previously diagnosed early breast cancer who suffered from bothersome menopausal symptoms such as hot flushes and night sweats.

Arimidex (anastrozole), Tamoxifen alone or in Combination (ATAC) trial

Commenced 1998 – completed 2015

Purpose

This international trial investigated which was the best treatment; Arimidex (anastrozole) alone, tamoxifen alone of anastrozole and tamoxifen in combination (taken daily over five years).

Pilot sentinel node biopsy study

Commenced 1999 – completed 2001

Purpose

This work was part of an initial phase of introducing sentinel node biopsy to breast cancer surgery at Waikato Hospital.  The study was supported by a grant from the Waikato Medical Research Foundation.

Australia New Zealand Breast Cancer Trials Group Study No. 9002. The Management of Screen Detected Ductal Carcinoma Insitu (DCIS) of the breast.

Commenced 1996 – completed 2016

Purpose

This trial evaluated the effectiveness of additional tamoxifen, radiotherapy to the breast, or both treatments, with no additional treatment following complete surgical excision of ductal carcinoma in situ of the breast.

IBCSG 10-93 Surgical therapy with or without axillary node clearance for breast cancer in older patients who receive adjuvant therapy with tamoxifen.

Commenced 1996 – completed 2005

Purpose

This international clinical trial investigated whether avoiding axillary surgery in older women would result in improved quality of life with similar disease-free survival and overall survival. Axillary clearance in early breast cancer aims to improve locoregional control (control of cancer in the breast and armpit) and provide staging information but is associated with undesirable side effects.