title: 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.
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.
  
  
  CONCLUSIONS
  This is the first chemoprevention trial in premenopausal women at increased risk for breast cancer.
authors.affiliation: German Breast Group, Neu-Isenburg, Germany. Gunter.vonMinckwitz@germanbreastgroup.de
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.forename: Christian
authors.initials: C
authors.lastname: Jackisch
authors.forename: Stefan
authors.initials: S
authors.lastname: Paepke
authors.forename: Caroline
authors.initials: C
authors.lastname: Nestle-Kraemling
authors.forename: Michael P
authors.initials: MP
authors.lastname: Lux
authors.forename: Nico
authors.initials: N
authors.lastname: Maass
authors.forename: Rita
authors.initials: R
authors.lastname: Schmutzler
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
authors.forename: Diethelm
authors.initials: D
authors.lastname: Wallwiener
authors.forename: Sabine
authors.initials: S
authors.lastname: Vescia
authors.forename: Kai
authors.initials: K
authors.lastname: Budischewski
authors.forename: Manfred
authors.initials: M
authors.lastname: Kaufmann
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D004164:Diphosphonates / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D017273:Goserelin / Q000627:therapeutic use*; D019584:Hot Flashes; D006801:Humans; D000077557:Ibandronic Acid; D008403:Mass Screening / Q000706:statistics & numerical data*; D008875:Middle Aged; D017697:Premenopause; D011379:Prognosis; D012307:Risk Factors
chemical_list: D018931:Antineoplastic Agents, Hormonal; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D017273:Goserelin; D000077557:Ibandronic Acid