| Studies currently open for accrual |
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- Studies to reduce the side effects of treatment
- A study to see whether use of intraoperative local anaesthetic results in better pain relief after surgery.
- A study to determine the local incidence of side effects (such as lymphoedema) associated with surgery to the lymph nodes of the armpit
- A study to evaluate the use of hormonal treatments in younger/premenopausal women
- the IBCSG Study 24-02 is the Suppression of Ovarian Function Trial (SOFT). This is testing the role of ovarian function suppression and the role of exemestane in premenopausal women with hormone sensitive breast cancer.
- Studies further evaluating sentinel node biopsy
- the SNAC (Sentinel Node biopsy versus Axillary Clearance trial) Part 2. The initial SNAC Part 1 trial (now closed to accrual) aimed to answer the question; “Does sentinel node biopsy (removal of the first lymph nodes related to breast cancer) result in reduced side effects from surgery compared to standard axillary clearance?” Part 2 of this research extends the work started in part 1. This extension evaluates the use of sentinel node biopsy in women with larger breast cancers or with more than one cancer in the breast. Part 2 of the SNAC trial will contribute to answering 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?”
- the IBCSG Study 23 is research which aims to contribute to the question of appropriate management for women who have micrometastases (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?
- Research evaluating whether there is a “best” aromatase inhibitor
- the Femara versus Anastrozole Clinical Evaluation (FACE) trial involves the head to head comparison of the new hormonal agents femara (also known as letrozole) and anastrozole (also known as arimidex) for postmenopausal women with hormone sensitive and lymph node positive early breast cancer.
- The International Breast cancer Intervention Study (IBIS) 2
- this international study is evaluating whether the drug anastrozole can prevent breast cancer in women at elevated risk (mostly due to significant family history). The second part to this study is a comparison of the use of anastrozole compared to tamoxifen for women with hormonally sensitive ductal carcinoma insitu (DCIS). The third part to this study is a bone sub study. This is an option for women participating in the IBIS 2 prevention and will evaluate further the impact of risedronate (a bisphosphonate or bone protecting drug) on bone health.
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| Studies
closed to further accrual with ongoing follow-up |
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- International Breast cancer Intervention Study (IBIS) 1
- This United Kingdom based study is testing whether the drug tamoxifen can prevent breast cancer in women at elevated risk for breast cancer (mostly due to a strong family history of the disease).
- The best treatment of a precancerous breast condition called ductal carcinoma insitu (DCIS)
- This research compares surgery alone with the addition of radiotherapy or tamoxifen, or both, for the treatment of DCIS.
- The Menstrual Cycle Study
- Co-ordinated through the North Central Cancer Treatment Group (USA) and is evaluating whether timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome – namely, the likelihood of breast cancer recurrence or death.
- The International Breast Cancer Study Group (IBCSG) Study 10-93
- Examines whether removal of the armpit lymph nodes is necessary in some older (60 years and over) women diagnosed with early breast cancer.
- The “HABITS” trial
- The HABITS (Hormone replacement therapy After Breast cancer, is IT Safe?) trial has evaluated the safety of a short course (up to two years) of hormone replacement therapy in women with a previously diagnosed early breast cancer who suffer from bothersome menopausal symptoms such as hot flushes, night sweats and vaginal dryness.
- The use of the newer hormonal treatments for early breast cancer in post menopausal women
- The Waikato is a centre for three different trials evaluating the use of the newer antioestrogen drugs (called aromatase inhibitors) anastrozole, letrozole and exemestane. These are being compared with the previous standard breast cancer drug tamoxifen.
- The “ATAC” trial is comparing Anastrozole and Tamoxifen Alone or in Combination.
- The Intergroup Exemestane Study (IES) compares five years of tamoxifen with two-three years of tamoxifen followed by two-three years exemestane.
- The Breast International Group (BIG 1-98) study compares letrozole and tamoxifen alone or the sequential use of these medications.
- The ZOFAST trial
- The aromatase inhibitors are known to reduce bone density and this study is for women taking letrozole for early breast cancer treatment and evaluates whether bone density protection with Zoledronate should be started immediately or only if bone density drops by more than a certain amount. All participants receive calcium and vitamin D for bone health as part of this research.
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| Upcoming
studies and studies planned |
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- the LATER (Later Adjuvant aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer) study is for women who have completed a five year course of hormonal therapy for early, hormone sensitive breast cancer at least one year previously. We know that 50% of recurrences occur after the first five years. The LATER study will determine whether offering women in this situation, who are free of recurrence, late treatment with letrozole and whether this is better than placebo.
- The SOLE (Study Of Letrozole Extension) trial is evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of previous hormonal therapy for postmenopausal women with hormone-receptor positive and node positive early breast cancer.
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