ACTRN12605000416695
Active, not recruiting
Phase 2
IBCSG 24-02 / BIG 2-02: Suppression of Ovarian Function Trial. A phase III trial evaluating the role of ovarian function suppression and the role of Exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Adjuvant Breast Cancer
- Sponsor
- Breast Cancer Trials
- Enrollment
- 3066
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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