Trial · Interventional

CompletedPhase 3Results postedRegistry data

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

Short name Co-SOFT

NCTNCT00659373Other idCDR0000594003Other idIBCSG-24-02-ANZ0701Other idANZ0701Other idCALGB-IBCSG-24-02-ANZ0701

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 86 participants (actual)
Sponsor: ETOP IBCSG Partners Foundation · Network
Design: Randomized · Open label (no masking)
Countries: 2 countries
United States, Canada
Start: Dec 2007
Primary completion: Dec 2014
Completion: Apr 2016
First posted: 16 Apr 2008 (estimated)
Last update posted: 25 Jul 2016 (estimated)
Conditions: Breast Cancer · Fatigue · Sleep Disorders

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082010201220142016

Ph 3
Co-SOFT
NCT00659373
Dec 2007 to Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression (E+ OFS) on brain function may help doctors plan cancer treatment. PURPOSE: This study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical trial IBCSG-2402.

Interventions

TamoxifenDrug
triptorelinDrug
ExemestaneDrug

Arms3

Active comparator
Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Experimental
T+OFS
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Experimental
E+OFS
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)
Time frame · 1 year after patient randomization to parent IBCSG 24-02 study
Registry description
Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1 year after patient randomization to parent IBCSG 24-02 study

Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)

Group	Value (standardized units)	Spread
Tamoxifen	-.04	0.49
Ovarian Function Suppression	-0.21	0.92

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TamoxifenTamoxifen 20mg orally daily for 5 years	–	0 / 20	0 / 20
Ovarian Function SuppressionTamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	–	0 / 54	0 / 54

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultPhillips KA, Regan MM, Ribi K, Francis PA, Puglisi F, Bellet M, Spazzapan S, Karlsson P, Budman DR, Zaman K, Abdi EA, Domchek SM, Feng Y, Price KN, Coates AS, Gelber RD, Maruff P, Boyle F, Forbes JF, Ahles T, Fleming GF, Bernhard J. Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 Apr 26;114(9):956-64. doi: 10.1038/bjc.2016.71. Epub 2016 Apr 19. PMID 27092785

Eligibility

Who could join, as posted.

Sex: Female
Age: up to 120 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Completely resected disease * Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy * Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402: * Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist * Ovarian irradiation * Bilateral oophorectomy * Hormone receptor status: * Estrogen and/or progesterone receptor positive * Each tumor must be hormone receptor positive PATIENT CHARACTERISTICS: * Premenopausal * Can speak and read the local language(s) fluently PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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