Breast cancer: Preclinical and clinical evaluation of intraductally administered agents in early breast cancer

Science Translational Medicine

Volumn 3, Issue 106, 2011, Pages

  Stearns, Vered ^a   Mori, Tsuyoshi ^a,b   Jacobs, Lisa K ^a   Khouri, Nagi F ^a   Gabrielson, Edward ^a   Yoshida, Takahiro ^a   Kominsky, Scott L ^a   Huso, David L ^a   Jeter, Stacie ^a   Powers, Penny ^a   Tarpinian, Karineh ^a   Brown, Regina J ^a,c   Lange, Julie R ^a   Rudek, Michelle A ^a   Zhang, Zhe ^a   Tsangaris, Theodore N ^a   Sukumar, Saraswati ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^c Heart Center of the Rockies   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; CARBOPLATIN; DOXORUBICIN; DOXORUBICINOL; FLUOROURACIL; GLUCOSE; METHOTREXATE; NANOPARTICLE; PACLITAXEL; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; MACROGOL DERIVATIVE; METHYLNITROSOUREA;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD TOXICITY; BREAST CANCER; BREAST DISEASE; BREAST EPITHELIUM; CANCER INHIBITION; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TISSUE LEVEL; EXTRAVASATION; FEASIBILITY STUDY; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; MASTALGIA; MAXIMUM TOLERATED DOSE; NONHUMAN; PAIN; PARTIAL MASTECTOMY; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; RAT; SINGLE DRUG DOSE; SKIN TOXICITY; ADULT; ANIMAL; BREAST TUMOR; DRUG ADMINISTRATION ROUTE; EXPERIMENTAL NEOPLASM; PHASE 2 CLINICAL TRIAL; SPRAGUE DAWLEY RAT; UDDER;

ADULT; ANIMALS; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CARBOPLATIN; DOXORUBICIN; DRUG ADMINISTRATION ROUTES; FEMALE; FLUOROURACIL; HUMANS; MAMMARY GLANDS, ANIMAL; MAMMARY NEOPLASMS, ANIMAL; METHYLNITROSOUREA; PACLITAXEL; POLYETHYLENE GLYCOLS; RATS; RATS, SPRAGUE-DAWLEY; YOUNG ADULT;

EID: 80054920688     PISSN: 19466234     EISSN: 19466242     Source Type: Journal    
DOI: 10.1126/scitranslmed.3002368     Document Type: Article

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17. Acknowledgments: We thank S. Love for her guidance with study design, training, and continuing support of this research. We thank N. Davidson for her support and helpful suggestions. We thank N. Kouprina, P. Argani, C. Balch, T. Bao, S. Briest, N. Davidson, J. Fetting, A. Wolff, and M. Zhao for support with study design, enrollment, and conduct. We thank L. Shockney, T. Driscoll, and the staff of the Avon Breast Center for their help in study enrollment and support of participants. We thank J. S. Lee for pathology advice. Funding: Supported by the National Cancer Institute NCI-AVON Progress for Patients (3P30 CA0069773-44S2) (V.S.), Windy Hill Medical (V.S. and S.S.), Mary Kay Ash Foundation (V.S.), Susan Love Research Foundation (R.J.B.), and 3P30 CA069773 (M.A.R.). Abraxane for preclinical studies was provided by Abraxis Inc. Author contributions: V.S. conceived the clinical study, supervised the regulatory submission, analyzed the data, supervised the clinical procedures, and wrote the manuscript. T.M. designed, conducted, and analyzed the preclinical experiments and performed the in vivo binding assays. T.Y. assessed mammary gland whole mounts. S.L.K. performed preclinical experiments and assisted in analysis. Z.Z. designed, performed statistical analysis for preclinical and clinical studies, and wrote descriptions of the statistical methods. E.G. performed histopathological evaluation of clinical study specimens. D.L.H. performed histopathological evaluation of preclinical study specimens. M.A.R. performed pharmacokinetic analysis. S.S. designed, supervised, analyzed data, and wrote descriptions of the preclinical project. V.S., L.K.J., N.F.K., S.J., P.P., K.T., R.J.B., J.R.L., and T.N.T. enrolled and monitored study patients and performed study procedures. All authors reviewed and approved the final manuscript. Competing interests: S.S. has served as a consultant to Windy Hill Medical (Los Angeles, CA). Accession numbers: The clinical trial has been registered and description of the design can be found on http://www.clinicaltrials.gov (NCT00290732).