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AzTrials

Breast CancerPhase 3Co-SOFTNCT00659373

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

A Phase 3 study testing Tamoxifen, triptorelin and Exemestane in people with Breast Cancer and Fatigue, run by ETOP IBCSG Partners Foundation at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 120 years, women only
Conditions the study is for
Breast Cancer, Fatigue, Sleep Disorders
What is being tested?
Tamoxifen, triptorelin and Exemestane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
15 sitesin 2 countries
Study dates
Dec 2007to Apr 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States13 sites

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Mercy General Hospital

    Sacramento, California, 95819

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

Other trials in United States

Canada2 sites

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

Other trials in Canada

About this study

Official title: Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

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.

Read the detailed description

OBJECTIVES:

Primary:

  • To evaluate and compare the changes in cognitive function over one 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).

OUTLINE: This is a multicenter study.

Objective cognitive function was measured with the CogState computerized test battery. The CogState battery consists of seven tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT), and ISLT-Delayed Recall. Performance speed is measured for the Detection, Identification and Monitoring tasks and performance accuracy is measured for the Memory, Learning, ISLT, and ISLT-Delayed Recall. Measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation. The main outcome measure is a composite score which is the average of these task scores (after transformation and standardization by age-specific norms). Patients complete these assessments at baseline (i.e. before start of protocol hormonal therapy) and approximately one year after randomization to the parent IBCSG 24-02 (SOFT) study.

Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.

Being tested
Tamoxifen, triptorelin, Exemestane
Keywords
cognitive/functional effects, psychosocial effects of cancer and its treatment, fatigue, sleep disorders, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms, Fatigue, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

    Also called Nolvadex

  • triptorelinDrug

    Also called GnRH analogue, Trelstar Depot, Decapeptyl Depot

  • ExemestaneDrug

    Also called Aromasin

Study groups in NCT00659373
Study groupRoleWhat they receive
TamoxifenActive comparatorTamoxifen 20mg orally daily for 5 years
Receives: Drug: Tamoxifen
T+OFSExperimentalTamoxifen 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)
Receives: Drug: Tamoxifen; Drug: triptorelin
E+OFSExperimentalExemestane 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)
Receives: Drug: triptorelin; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: 1 year after patient randomization to parent IBCSG 24-02 study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00659373
Sponsor's protocol ID
CDR0000594003
Other IDs
IBCSG-24-02-ANZ0701, ANZ0701, CALGB-IBCSG-24-02-ANZ0701
Acronym
Co-SOFT
Status last verified
Jul 2016
First submitted
15 Apr 2008
Last updated
25 Jul 2016
Data monitoring committee
Yes

Publications

  • Phillips 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.

    PubMed 27092785

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tamoxifen, triptorelin and Exemestane in people with Breast Cancer and Fatigue, run by ETOP IBCSG Partners Foundation at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00659373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.

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