None listed
Conditions
Brief summary
Phase 3 This trial evaluates the role of suppressing ovarian function, and also the role of the drug exemestane as preventative therapies for premenopausal women with breast cancer that responds to hormones. Who is it for? You can join this study if you are a woman with early breast cancer that responds to hormones and you are still premenopausal even after treatment (with surgery or chemotherapy). Trial details Chemotherapy, hormone tablets, and turning off the ovaries all reduce the risk of breast cancer coming back in young women with early breast cancer that responds to hormone therapy. However it is unclear whether all 3 are necessary or what the best way to combine them is. This study will determine if turning off the ovaries for 5 years helps young women with early breast cancer Participants will be randomly assigned to receive Tamoxifen alone (standard treatment for this group of patients), ovarian function suppression with Tamoxifen, or ovarian function suppression with Exemestane (a drug designed to reduce the amount of oestrogen in the body, so as to reduce cancer growth). Patients assigned to ovarian function suppression as part of their treatment will be able to choose the method of treatment (either by tablet, radiotherapy or surgery).
Interventions
IBCSG 24-02 / BIG 2-02 (SOFT) is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia and New Zealand Breast Cancer Trials Group). This study will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue (triptorelin), surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopaus
IBCSG 24-02 / BIG 2-02 (SOFT) is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia and New Zealand Breast Cancer Trials Group). This study will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue (triptorelin), surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopausal women with steroid hormone receptor positive early invasive breast cancer who either receive no adjuvant chemotherapy or remain premenopausal following adjuvant and/or neoadjuvant chemotherapy. In addition, the worth of exemestane will be evaluated for this premenopausal patient population by comparing ovarian function suppression plus exemestane with tamoxifen alone and by comparing ovarian function suppression plus exemestane with ovarian function suppression plus tamoxifen. IBCSG 24-02 / BIG 2-02 (SOFT) is an international, multicentre, randomised phase III clinical trial of 3000 premenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer. Women will be randomised in a 3-arm design to receive one of the following: a. Tamoxifen b. Ovarian Function Suppression + tamoxifen c. Ovarian Function Suppression + exemestane Patients are stratified according to institution, prior chemotherapy, number of positive nodes and the intended initial method of ovarian function suppression if assigned by randomization. All treatment will be for 5 years.
Sponsors
Breast Cancer Trials
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, hormone receptor positive, completely resected breast cancer which is confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy; 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 or are planning oophorectomy within 5 years of entry; pregnant or lactating at randomization; 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 for more than 6 months after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; patients who have received GnRH analogues as part of their breast cancer treatment prior to randomisation.
Outcome results
None listed