Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH): study protocol.
BACKGROUND
Young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other) cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors.


METHODS
The study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1st June 2001 to 31st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period.


CONCLUSIONS
Power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80%) receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward.
Eccles
Diana
D
Somers Cancer Sciences Building Mail Point 824, Southampton University Hospitals NHS Trust, Tremona Road, Southampton SO16 6YA, UK. de1@soton.ac.uk
Gerty
Sue
S
Simmonds
Peter
P
Hammond
Victoria
V
Ennis
Sarah
S
Altman
Douglas G
DG
D000328:Adult; D018070:Biological Specimen Banks; D001943:Breast Neoplasms / Q000188:drug therapy / Q000453:epidemiology* / Q000235:genetics / Q000601:surgery; D015331:Cohort Studies; D003131:Combined Modality Therapy; D004739:England / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D006801:Humans; D008875:Middle Aged; D009386:Neoplastic Syndromes, Hereditary / Q000188:drug therapy / Q000453:epidemiology* / Q000601:surgery; D011379:Prognosis; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
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