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

Phase 3 Completed 86 enrolled ETOP IBCSG Partners Foundation Breast Cancer Trials, Australia and New Zealand · collab Cancer and Leukemia Group B · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-label

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.

Timeline

Start: 2007-12
Primary completion: 2014-12
Completion: 2016-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Tamoxifen vs Ovarian Function Suppression; p = 0.71; Wilcoxon (Mann-Whitney) NCT00659373 ↗

paper There was no significant difference in the changes in the composite cognitive function scores between the OFS+ tamoxifen or exemestane groups and the tamoxifen group PMID 27092785 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exemestane	Small molecule	25 mg	Oral
Subject	Tamoxifen	Small molecule	20 mg	Oral
Subject	Triptorelin	Other / unclassified	3.75 mg	Intramuscular