Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

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Giobbie-Hurder, Anita (author)

Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

Article/chapterEnglish2009

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2009-06-15
SAGE Publications,2009

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LIBRIS-ID:oai:gup.ub.gu.se/100418
https://gup.ub.gu.se/publication/100418URI
https://doi.org/10.1177/1740774509105380DOI

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Language:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

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BACKGROUND: Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. PURPOSE: To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. METHODS: From 1998-2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. RESULTS: The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. LIMITATIONS: Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. CONCLUSIONS: BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years apart, and subject to evolving analytic plans influenced by new data that emerge over time.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Cancer och onkologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Cancer and Oncology hsv//eng
Antineoplastic Agents
Hormonal
therapeutic use
Aromatase Inhibitors
therapeutic use
Breast Neoplasms
blood
drug therapy
Chemotherapy
Adjuvant
Double-Blind Method
Drug Therapy
Combination
Estrogen Antagonists
therapeutic use
Female
Humans
Nitriles
therapeutic use
Postmenopause
Receptors
Estrogen
blood
Research Design
Tamoxifen
therapeutic use
Treatment Outcome
Triazoles
therapeutic use
Tumor Markers
Biological
blood

Added entries (persons, corporate bodies, meetings, titles ...)

Price, Karen N (author)
Gelber, Richard D (author)
Wallgren, Arne,1940Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences(Swepub:gu)xwalar (author)
Göteborgs universitetInstitutionen för kliniska vetenskaper (creator_code:org_t)

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In:Clinical trials (London, England): SAGE Publications6:3, s. 272-871740-77451740-7753

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