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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000542493

Acronym

Co-SOFT

Enrollment

Registered

2007-10-23

Start date

2008-10-28

Completion date

2010-04-30

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

Inclusion criteria

All patients must be randomised to the parent SOFT trial but not yet started protocol hormonal therapy; Patients must not have received any adjuvant endocrine therapy either before or after randomisation to the SOFT trial; Patients must be able to speak and read English fluently; Informed consent must be obtained prior to registration.

Exclusion criteria

Patients who commenced adjuvant endocrine therapy prior to randomisation to the SOFT parent trial are not eligible to participate in the Co-SOFT substudy.

Outcome results