Phase 3
Completed N=86
Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Source: ClinicalTrials.gov NCT00659373 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: 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
◆ Published Evidence
Established
39citations · ~4 / year
Adjuvant ovarian function suppression and cognitive function in women with breast cancer.
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.
Linked Publications
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Adjuvant ovarian function suppression and cognitive function in women with breast cancer.
Outcome Measures
| Outcome | Result | p-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 |
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
Data sourced from ClinicalTrials.gov (NCT00659373) and the linked publication. 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. Informational only — not medical advice.