Novel translational model for breast cancer chemoprevention study: Accrualto a presurgical intervention with tamoxifen and N-[4-hydroxyphenyl] retinamide

Citation
E. Singletary et al., Novel translational model for breast cancer chemoprevention study: Accrualto a presurgical intervention with tamoxifen and N-[4-hydroxyphenyl] retinamide, CANC EPID B, 9(10), 2000, pp. 1087-1090
Citations number
18
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION
ISSN journal
1055-9965 → ACNP
Volume
9
Issue
10
Year of publication
2000
Pages
1087 - 1090
Database
ISI
SICI code
1055-9965(200010)9:10<1087:NTMFBC>2.0.ZU;2-4
Abstract
Surrogate end point biomarkers for risk assessment and efficacy of potentia l chemopreventive agents are needed to improve the efficiency and reduce th e cost of chemoprevention trials, It is imperative to develop the best clin ical breast model for translational surrogate end point biomarker studies, especially with respect to accrual feasibility. We have initiated a prospec tive study to develop biomarkers for tamoxifen and N-[4-hydroxyphenyl] reti namide by administering either a placebo or both drugs for 2-4 weeks to wom en with ductal carcinoma in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery, The prin ciple end point is pretreatment versus posttreatment tumor levels of Ki-67; a number of other exploratory markers will also be examined. The planned t arget sample size is 100 patients. Between February 1997 and February 2000, 4514 women who had either an abnormal mammogram or a diagnosed breast canc er were screened for the study. Of these 4514 screened patients, 52 (1%) we re registered on the study. Major factors of nonparticipation in the remain ing 4462 women were as follows: (a) no evidence of malignancy (2081 patient s; 46%); (b) ineligible per protocol criteria (575 patients; 13%); (c) preo perative chemotherapy/tamoxifen (520 patients; 11%); (d) surgery scheduling conflict (360 patients; 8%); (e) outside needle biopsy (221 patients; 5%); (f) no residual disease after excisional biopsy (345 patients; 8%); and (g ) second opinion only (123 patients; 3%), Other nonparticipation factors in cluded fine needle aspiration only, refusal, tumor size >2 cm, and estrogen replacement therapy (35 patients each; 2% each). The protocol was amended in midstudy to allow outside needle biopsy, tumor >2 cm, and estrogen repla cement therapy, Accrual to biomarker (nontherapeutic) protocols with delay in definitive cancer surgery is challenging but feasible. Although some acc rual problems remain, we have nonetheless succeeded in recruiting 50% of ou r target sample size in a 3-year period.