TerminatedPhase 3ACTRN12607000542493

Cognitive Function Substudy - A substudy to the SOFT trial (ACTRN12605000416695) which evaluates the cognitive function of premenopausal women with endocrine responsive breast cancer participating in SOFT.

A substudy to the SOFT trial (ACTRN12605000416695). The SOFT trial evaluates the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer. The Co-SOFT substudy investigates cognitive function of patients participating in the SOFT parent trial at selected centres.


Sponsor

Breast Cancer Trials

Enrollment

357 participants

Start Date

Oct 28, 2008

Study Type

Interventional

Conditions

Summary

Phase 3 This study looks at cognitive (mental) function among premenopausal women with hormone-responsive breast cancer participating in SOFT (ACTRN12605000416695). Who is it for? You can join this study if you are participating in the SOFT trial and you have not yet started (or previously received) hormone treatment. Trial details Testing will measure and compare cognitive function among women in different treatment groups in the SOFT trial. Cognitive function will be measured using a set of computerised card memory games.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about cognitive Function Substudy - A substudy to the SOFT trial (ACTRN12605000416695) which evaluates the cognitive function of premenopausal women with endocrine responsive breast cancer participating in SOFT.. It is looking for adults aged 18 and older to participate. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Prior to registration in the Co-SOFT substudy, all patients must be randomised to the SOFT (ACTRN12605000416695) parent trial. The SOFT trial is a phase III trial evaluating the role of ovarian f

Prior to registration in the Co-SOFT substudy, all patients must be randomised to the SOFT (ACTRN12605000416695) parent trial. The SOFT trial is 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. Patients participating in the SOFT trial will be randomised to receive five years of tamoxifen (20mg orally daily), five years of tamoxifen (20mg orally daily) plus ovarian function suppression (via either GnRH analogue, surgical oophorectomy or ovarian irradiation) or five years of exemestane (25mg orally daily) plus ovarian function suppression (via either GnRH analogue, surgical oophorectomy or ovarian irradiation). The method of ovarian function suppression may be determined by the treating clinican/patient and may be altered during the five year period, if necessary. Patients may subsequently be registered to the Co-SOFT substudy, investigating cognitive function for patients participating in the SOFT parent trial. Cognitive function will be measured with a computerised test battery (CogState) consisting of computerised card games. Self reported cognitive function, psychological distress and fatigue will also be assessed via three multiple response based questionnaires.


Locations(1)

New Zealand

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ACTRN12607000542493