von Minckwitz, Gunter, Loibl, Sibylle, Jackisch, Christian, Paepke, Stefan, Nestle-Kraemling, Caroline, Lux, Michael P., Maass, Nico, Schmutzler, Rita, du Bois, Andreas, Wallwiener, Diethelm, Vescia, Sabine, Budischewski, Kai and Kaufmann, Manfred (2011). The GISS Trial: a Phase II Prevention Trial of Screening Plus Goserelin, Ibandronate, versus Screening Alone in Premenopausal Women at Increased Risk of Breast Cancer. Cancer Epidemiol. Biomarkers Prev., 20 (10). S. 2141 - 2150. PHILADELPHIA: AMER ASSOC CANCER RESEARCH. ISSN 1538-7755

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Abstract

Background: Genetic testing for inherited mutations in breast cancer genes provides valuable information for disease prevention. Today, premenopausal women with increased risk for breast cancer have only limited nonsurgical options to reduce their risk. Methods: The GISS trial, a randomized, multicenter, open-label phase II trial, assessed the feasibility of a preventive treatment with goserelin and ibandronate for premenopausal women at increased risk for breast cancer. The primary endpoints were refusal to undergo randomization and discontinuation of treatment. Safety and quality of life were also evaluated. Results: Between the years 2001 and 2003, 31 of 322 eligible women participated in the trial; 15 received goserelin/ibandronate plus screening, 15 screening only, and 1 withdrew her consent after randomization. The treatment duration was 24 months. Here, mainly the results from the first 12 months were evaluated because of the low compliance thereafter. Hot flushes, headache, and vaginal dryness/discharge occurred more often in the goserelin arm. No difference was observed between the two arms in the agreement to randomization, compliance, or any other endpoints. Conclusions: Acceptance of chemoprevention with goserelin and ibandronate was low. Premenopausal women at increased risk for breast cancer should be better informed about chemoprevention through physician counseling and a more feasible study design (e.g., oral medication) should be provided. Impact: This is the first chemoprevention trial in premenopausal women at increased risk for breast cancer. Cancer Epidemiol Biomarkers Prev; 20(10); 2141-9. (C)2011 AACR.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
von Minckwitz, GunterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loibl, SibylleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jackisch, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paepke, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nestle-Kraemling, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lux, Michael P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maass, NicoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmutzler, RitaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
du Bois, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wallwiener, DiethelmUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vescia, SabineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Budischewski, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaufmann, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-487788
DOI: 10.1158/1055-9965.EPI-11-0222
Journal or Publication Title: Cancer Epidemiol. Biomarkers Prev.
Volume: 20
Number: 10
Page Range: S. 2141 - 2150
Date: 2011
Publisher: AMER ASSOC CANCER RESEARCH
Place of Publication: PHILADELPHIA
ISSN: 1538-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
QUALITY-OF-LIFE; HORMONE REPLACEMENT THERAPY; BRCA2 MUTATION CARRIERS; PROSE-STUDY-GROUP; STAR P-2 TRIAL; PROPHYLACTIC OOPHORECTOMY; POSTMENOPAUSAL WOMEN; TAMOXIFEN; MASTECTOMY; RALOXIFENEMultiple languages
Oncology; Public, Environmental & Occupational HealthMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/48778

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