None listed
Conditions
Brief summary
Estrogen can stimulate the growth of breast tumor cells. Suppression of ovarian function combined with hormone therapy may fight breast cancer by reducing the production of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether suppression of ovarian function and hormone therapy are more effective with or without chemotherapy in treating breast cancer. This randomized phase III trial is studying how well giving ovarian-function suppression together with hormone therapy and chemotherapy works compared to ovarian-function suppression and hormone therapy alone in treating premenopausal women with resected breast cancer.
Interventions
IBCSG 26-02 / BIG 4-02 (PERCHE) 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 adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for 5 years.
IBCSG 26-02 / BIG 4-02 (PERCHE) 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 adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for 5 years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for 5 years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator. IBCSG 26-02 / BIG 4-02 (PERCHE) is an international, multicentre, randomised phase III clinical trial of 1750 premenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program. Women will be randomised in a 2-arm design to receive one of the following: a. Chemotherapy + Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane b. Ovarian Function Suppression (triptorelin) + Tamoxifen/Exemestane All hormonal treatment will be for 5 years.
Sponsors
Australia and New Zealand Breast Cancer Trials Group Ltd
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