None listed
Conditions
Brief summary
Research has shown that exemestane works better in postmenopausal women because their ovaries are no longer producing oestrogen. TEXT will determine if suppressing ovarian function in premenopausal women (i.e. reducing oestrogen production) will allow exemestane to work in the same way as it does for postmeopausal women. This trial is designed for participants who should receive ovarian function suppression from the start of their adjuvant breast cancer treatment.
Interventions
IBCSG 25-02 / BIG 3-02 (TEXT) is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by the Australian and New Zealand Breast Cancer Trials Group (ANZ BCTG).
This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive b
IBCSG 25-02 / BIG 3-02 (TEXT) is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by the Australian and New Zealand Breast Cancer Trials Group (ANZ BCTG). This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated. IBCSG 25-02 / BIG 3-02 (TEXT) is an international, multicentre, randomised phase III clinical trial of 1850 premenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer. Women will be randomised in a 2-arm design to receive one of the following: a. Ovarian Function Suppression (triptorelin) + Tamoxifen b. Ovarian Function Suppression (triptorelin) + Exemestane All treatment will be for 5 years.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-menopausal women with histologically proven, completely resected hormone receptor positive breast cancer confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy is required; geographically accessible for follow up; written informed consent provided.
Exclusion criteria
Post-menopausal women; distant metastatic disease; locally advanced inoperable breast cancer; supraclavicular node involvement; enlarged internal mammary nodes; bilateral invasive breast cancer; positive final margins; clinically detectable residual axillary disease; history of prior ipsilateral or contralateral invasive breast cancer; previous or concomitant malignancy; other non-malignant systemic diseases that would prevent prolonged follow-up; bilateral oophorectomy or ovarian irradiation; pregnant or lactating at randomisation, desire a pregnancy within 5 years or plan to use additional hormone therapy during next 5 years (including hormonal contraception); neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; prior neoadjuvant or adjuvant chemotherapy.
Outcome results
None listed