Clinical trial · Interventional
Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
| triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen
- description
- Tamoxifen 20mg orally daily for 5 years
- interventionNames
- Drug: Tamoxifen
- type
- EXPERIMENTAL
- label
- T+OFS
- description
- 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)
- interventionNames
- Drug: Tamoxifen
- Drug: triptorelin
- type
- EXPERIMENTAL
- label
- E+OFS
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- 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