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Phase 3 N=86 Randomized

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

Breast Cancer · Fatigue · Sleep Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00659373 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: 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) — -.04; -0.21 standardized units — p=0.71

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tamoxifen (Drug); triptorelin (Drug); Exemestane (Drug)
Age
Pediatric, Adult, Older Adult
Sex
Female
Sponsor
ETOP IBCSG Partners Foundation
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
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)		 -.04; -0.21 0.71

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. 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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00659373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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