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The following clinical trials are specifically for young women.
IBCSG 24-02 SOFT (Suppression of Ovarian Function Trial) - this trial is suitable for premenopausal women with hormone receptor positive breast cancer when the woman's ovaries are continuing to produce oestrogen (ie remain premenopausal) after chemotherapy (if given). For the hormonal part of their breast cancer treatment women are randomized to
(i) 5 years of tamoxifen alone (this is the standard arm)
(ii) 5 years of ovarian function suppression + tamoxifen
(iii) 5 years of ovarian function suppression + exemestane
The ovarian function suppression can be achieved by monthly injections (reversible method of inducing menopause) or by permanent methods (eg oophorectomy). Women can enter the trial up to 8 months after completion chemotherapy - ie they may have their periods stop for a while after chemotherapy and then restart and they can still be suitable for the trial.
IBCSG 25-02 TEXT (Tamoxifen and Exemestane Trial) - this trial is suitable for premenopausal women with hormone receptor positive breast cancer when the doctor and woman think she should definitely receive ovarian function suppression as part of her treatment. Chemotherapy is optional according to patient and clinician preference. Randomization for hormonal part of treatment to:
(i) 5 years of ovarian function suppression + tamoxifen
(ii) 5 years of ovarian function suppression + exemestane
IBCSG 34 POEMS (Prevention of Early Menopause Study) - this trial is suitable for premenpausal women with hormone receptor negative (ER and PR negative) breast cancer who will receive adjuvant chemotherapy and want to avoid premature menopause which is a common side effect of chemotherapy. Women are randomized to receive in conjunction with their chemotherapy
(i) monthly injections of zoladex or (ii) no zoladex
Dr Prue Francis from Peter MacCalllum Cancer Institute chairs SOFT and TEXT within Australia and Dr Kelly Phillips also from Peter MacCalllum Cancer Institute chairs POEMS if additional information is required. There is some information on ANZ BCTG website in clinical trials section,
see http://www.anzbctg.org/default.asp?file=clintrials.asp&TrialType=Main
Oncologists can provide contact with these trials.
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