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Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial.

Golshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M.

JAMA Surg. 2020 Jan 8:e195410. doi: 10.1001/jamasurg.2019.5410. [Epub ahead of print]


Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status From SystHERs.

Cobleigh M, Yardley D, Brufsky AM, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Hurvitz SA, O'Shaughnessy J, Mason G, Antao V, Li H, Chu L, Jahanzeb M.

Clin Cancer Res. 2019 Nov 26. pii: clincanres.2350.2019. doi: 10.1158/1078-0432.CCR-19-2350. [Epub ahead of print]


Randomized phase-II evaluation of letrozole plus dasatinib in hormone receptor positive metastatic breast cancer patients.

Paul D, Vukelja SJ, Ann Holmes F, Blum JL, McIntyre KJ, Lindquist DL, Osborne CR, Sanchez IJ, Goldschmidt JH, Wang Y, Asmar L, Strauss L, O'Shaughnessy J.

NPJ Breast Cancer. 2019 Oct 28;5:36. doi: 10.1038/s41523-019-0132-8. eCollection 2019.


De Novo Versus Recurrent HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from the SystHERs Registry.

Tripathy D, Brufsky A, Cobleigh M, Jahanzeb M, Kaufman PA, Mason G, O'Shaughnessy J, Rugo HS, Swain SM, Yardley DA, Chu L, Li H, Antao V, Hurvitz SA.

Oncologist. 2019 Oct 14. pii: theoncologist.2019-0446. doi: 10.1634/theoncologist.2019-0446. [Epub ahead of print]


Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial.

Golshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M.

Eur J Surg Oncol. 2019 Oct 5. pii: S0748-7983(19)30883-2. doi: 10.1016/j.ejso.2019.10.002. [Epub ahead of print]


Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial.

Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnović Ž, Vasev N, Ma L, Richards DA, Wilks ST, Milenković D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J.

Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28.


Feasibility of conducting an active exercise prehabilitation program in patients awaiting spinal stenosis surgery: a randomized pilot study.

Marchand AA, Suitner M, O'Shaughnessy J, Châtillon CÉ, Cantin V, Descarreaux M.

Sci Rep. 2019 Aug 22;9(1):12257. doi: 10.1038/s41598-019-48736-7.


Patient-derived xenografts of central nervous system metastasis reveal expansion of aggressive minor clones.

Tew BY, Legendre C, Schroeder MA, Triche T, Gooden GC, Huang Y, Butry L, Ma DJ, Johnson K, Martinez RA, Pierobon M, Petricoin EF, O'shaughnessy J, Osborne C, Tapia C, Buckley DN, Glen J, Bernstein M, Sarkaria JN, Toms SA, Salhia B.

Neuro Oncol. 2020 Jan 11;22(1):70-83. doi: 10.1093/neuonc/noz137.


Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J.

Ann Oncol. 2019 Nov 1;30(11):1842. doi: 10.1093/annonc/mdz215. No abstract available.


Systematic literature review of clinical trials of endocrine therapies for premenopausal women with metastatic HR+ HER2- breast cancer.

Patterson-Lomba O, Dalal AA, Ayyagari R, Liu O, Dervishi E, Platt E, Chandiwana D, O'Shaughnessy JA.

Breast J. 2019 Sep;25(5):880-888. doi: 10.1111/tbj.13345. Epub 2019 Jul 9.


Health-related quality of life in patients receiving first-line eribulin mesylate with or without trastuzumab for locally recurrent or metastatic breast cancer.

Schwartzberg L, McIntyre K, Wilks S, Puhalla S, O'Shaughnessy J, Berrak E, He Y, Vahdat L.

BMC Cancer. 2019 Jun 13;19(1):578. doi: 10.1186/s12885-019-5674-5.


Ivermectin treatment failure on four Irish dairy farms.

O'Shaughnessy J, Drought Y, Lynch J, Denny M, Hurley C, Byrne W, Casey M, de Waal T, Sheehan M.

Ir Vet J. 2019 May 15;72:4. doi: 10.1186/s13620-019-0142-8. eCollection 2019.


Aberrant FGFR signaling mediates resistance to CDK4/6 inhibitors in ER+ breast cancer.

Formisano L, Lu Y, Servetto A, Hanker AB, Jansen VM, Bauer JA, Sudhan DR, Guerrero-Zotano AL, Croessmann S, Guo Y, Ericsson PG, Lee KM, Nixon MJ, Schwarz LJ, Sanders ME, Dugger TC, Cruz MR, Behdad A, Cristofanilli M, Bardia A, O'Shaughnessy J, Nagy RJ, Lanman RB, Solovieff N, He W, Miller M, Su F, Shyr Y, Mayer IA, Balko JM, Arteaga CL.

Nat Commun. 2019 Mar 26;10(1):1373. doi: 10.1038/s41467-019-09068-2.


Perspectives on the mechanism of action and clinical application of eribulin for metastatic breast cancer.

O'Shaughnessy J, Kaklamani V, Kalinsky K.

Future Oncol. 2019 May;15(14):1641-1653. doi: 10.2217/fon-2018-0936. Epub 2019 Mar 20. Review.


Evaluation of Miracle Mouthwash plus Hydrocortisone Versus Prednisolone Mouth Rinses as Prophylaxis for Everolimus-Associated Stomatitis: A Randomized Phase II Study.

Jones VE, McIntyre KJ, Paul D, Wilks ST, Ondreyco SM, Sedlacek S, Melnyk A, Oommen SP, Wang Y, Peck SR, O'Shaughnessy JA.

Oncologist. 2019 Sep;24(9):1153-1158. doi: 10.1634/theoncologist.2018-0340. Epub 2019 Mar 4.


Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer.

Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K.

N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.


Adverse events risk associated with bevacizumab addition to breast cancer chemotherapy: a meta-analysis.

Cortes J, Calvo V, Ramírez-Merino N, O'Shaughnessy J, Brufsky A, Robert N, Vidal M, Muñoz E, Perez J, Dawood S, Saura C, Di Cosimo S, González-Martín A, Bellet M, Silva OE, Miles D, Llombart A, Baselga J.

Ann Oncol. 2019 Jul 1;30(7):1179. doi: 10.1093/annonc/mdy535. No abstract available.


Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer.

Wu Y, Amonkar MM, Sherrill BH, O'Shaughnessy J, Ellis C, Baselga J, Blackwell KL, Burstein HJ.

Ann Oncol. 2019 Jun 1;30(6):1019. doi: 10.1093/annonc/mdy531. No abstract available.


Central Nervous System Metastasis in Patients with HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from SystHERs.

Hurvitz SA, O'Shaughnessy J, Mason G, Yardley DA, Jahanzeb M, Brufsky A, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Chu L, Li H, Antao V, Cobleigh M.

Clin Cancer Res. 2019 Apr 15;25(8):2433-2441. doi: 10.1158/1078-0432.CCR-18-2366. Epub 2018 Dec 28.


Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy.

Di Leo A, O'Shaughnessy J, Sledge GW Jr, Martin M, Lin Y, Frenzel M, Hardebeck MC, Smith IC, Llombart-Cussac A, Goetz MP, Johnston S.

NPJ Breast Cancer. 2018 Dec 18;4:41. doi: 10.1038/s41523-018-0094-2. eCollection 2018.


One-year parasitological screening of stray dogs and cats in County Dublin, Ireland.

Garcia-Campos A, Power C, O'Shaughnessy J, Browne C, Lawlor A, McCarthy G, O'Neill EJ, de Waal T.

Parasitology. 2018 Dec 18:1-7. doi: 10.1017/S0031182018002020. [Epub ahead of print]


Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study.

Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J.

Ann Oncol. 2019 Mar 1;30(3):397-404. doi: 10.1093/annonc/mdy517.


French-Canadian Adaptation and Validation of the Swiss Spinal Stenosis Questionnaire for Patients With Lumbar Spinal Stenosis.

Marchand AA, Tétreau C, OʼShaughnessy J, Descarreaux M.

Spine (Phila Pa 1976). 2019 Apr 15;44(8):E487-E493. doi: 10.1097/BRS.0000000000002896.


A Four-gene Decision Tree Signature Classification of Triple-negative Breast Cancer: Implications for Targeted Therapeutics.

Quist J, Mirza H, Cheang MCU, Telli ML, O'Shaughnessy JA, Lord CJ, Tutt ANJ, Grigoriadis A.

Mol Cancer Ther. 2019 Jan;18(1):204-212. doi: 10.1158/1535-7163.MCT-18-0243. Epub 2018 Oct 10.


Development of acquired resistance to lapatinib may sensitise HER2-positive breast cancer cells to apoptosis induction by obatoclax and TRAIL.

Eustace AJ, Conlon NT, McDermott MSJ, Browne BC, O'Leary P, Holmes FA, Espina V, Liotta LA, O'Shaughnessy J, Gallagher C, O'Driscoll L, Rani S, Madden SF, O'Brien NA, Ginther C, Slamon D, Walsh N, Gallagher WM, Zagozdzon R, Watson WR, O'Donovan N, Crown J.

BMC Cancer. 2018 Oct 11;18(1):965. doi: 10.1186/s12885-018-4852-1.


Genomic Alterations Associated with Recurrence and TNBC Subtype in High-Risk Early Breast Cancers.

Wilson TR, Udyavar AR, Chang CW, Spoerke JM, Aimi J, Savage HM, Daemen A, O'Shaughnessy JA, Bourgon R, Lackner MR.

Mol Cancer Res. 2019 Jan;17(1):97-108. doi: 10.1158/1541-7786.MCR-18-0619. Epub 2018 Aug 31.


Everolimus-based combination therapies for HR+, HER2- metastatic breast cancer.

O'Shaughnessy J, Thaddeus Beck J, Royce M.

Cancer Treat Rev. 2018 Sep;69:204-214. doi: 10.1016/j.ctrv.2018.07.013. Epub 2018 Jul 23. Review.


IL1 Receptor Antagonist Controls Transcriptional Signature of Inflammation in Patients with Metastatic Breast Cancer.

Wu TC, Xu K, Martinek J, Young RR, Banchereau R, George J, Turner J, Kim KI, Zurawski S, Wang X, Blankenship D, Brookes HM, Marches F, Obermoser G, Lavecchio E, Levin MK, Bae S, Chung CH, Smith JL, Cepika AM, Oxley KL, Snipes GJ, Banchereau J, Pascual V, O'Shaughnessy J, Palucka AK.

Cancer Res. 2018 Sep 15;78(18):5243-5258. doi: 10.1158/0008-5472.CAN-18-0413. Epub 2018 Jul 16.


nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial.

Yardley DA, Coleman R, Conte P, Cortes J, Brufsky A, Shtivelband M, Young R, Bengala C, Ali H, Eakel J, Schneeweiss A, de la Cruz-Merino L, Wilks S, O'Shaughnessy J, Glück S, Li H, Miller J, Barton D, Harbeck N; tnAcity investigators.

Ann Oncol. 2018 Aug 1;29(8):1763-1770. doi: 10.1093/annonc/mdy201.


Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J.

Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155.


A randomized, double-blind, phase 2 study of ruxolitinib or placebo in combination with capecitabine in patients with advanced HER2-negative breast cancer and elevated C-reactive protein, a marker of systemic inflammation.

O'Shaughnessy J, DeMichele A, Ma CX, Richards P, Yardley DA, Wright GS, Kalinsky K, Steis R, Diab S, Kennealey G, Geschwindt R, Jiang W, Rugo HS.

Breast Cancer Res Treat. 2018 Aug;170(3):547-557. doi: 10.1007/s10549-018-4770-6. Epub 2018 Apr 19.


Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2.

Verma S, O'Shaughnessy J, Burris HA, Campone M, Alba E, Chandiwana D, Dalal AA, Sutradhar S, Monaco M, Janni W.

Breast Cancer Res Treat. 2018 Aug;170(3):535-545. doi: 10.1007/s10549-018-4769-z. Epub 2018 Apr 13.


Change in Topoisomerase 1-Positive Circulating Tumor Cells Affects Overall Survival in Patients with Advanced Breast Cancer after Treatment with Etirinotecan Pegol.

Rugo HS, Cortes J, Awada A, O'Shaughnessy J, Twelves C, Im SA, Hannah A, Lu L, Sy S, Caygill K, Zajchowski DA, Davis DW, Tagliaferri M, Hoch U, Perez EA.

Clin Cancer Res. 2018 Jul 15;24(14):3348-3357. doi: 10.1158/1078-0432.CCR-17-3059. Epub 2018 Apr 4.


Five-year results of a phase II trial of preoperative 5-fluorouracil, epirubicin, cyclophosphamide followed by docetaxel with capecitabine (wTX) (with trastuzumab in HER2-positive patients) for patients with stage II or III breast cancer.

Holmes FA, Hellerstedt BA, Pippen JE Jr, Vukelja SJ, Collea RP, Kocs DM, Blum JL, McIntyre KJ, Barve MA, Brooks BD, Osborne CR, Wang Y, Asmar L, O'Shaughnessy J.

Cancer Med. 2018 Jun;7(6):2288-2298. doi: 10.1002/cam4.1472. Epub 2018 Mar 26.


Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial.

Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr.

Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.


Validation of the French-Canadian Pelvic Girdle Questionnaire.

Girard MP, O'Shaughnessy J, Doucet C, Lardon E, Stuge B, Ruchat SM, Descarreaux M.

J Manipulative Physiol Ther. 2018 Mar - Apr;41(3):234-241. doi: 10.1016/j.jmpt.2018.01.001. Epub 2018 Feb 15.


Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer.

Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J.

J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26.


Cytotechnologists as coinvestigators in anatomical pathology research.

Kopp KJ, Passow MR, Del Rosario KM, Christensen MR, O'Shaughnessy JW, Bartholet MK, Francis ME, Flotte TJ.

Cancer Cytopathol. 2018 Apr;126(4):232-235. doi: 10.1002/cncy.21968. Epub 2018 Jan 9.


Outcomes in women with invasive ductal or invasive lobular early stage breast cancer treated with anastrozole or exemestane in CCTG (NCIC CTG) MA.27.

Strasser-Weippl K, Sudan G, Ramjeesingh R, Shepherd LE, O'Shaughnessy J, Parulekar WR, Liedke PER, Chen BE, Goss PE.

Eur J Cancer. 2018 Feb;90:19-25. doi: 10.1016/j.ejca.2017.11.014. Epub 2017 Dec 20.


Polyclonal RB1 mutations and acquired resistance to CDK 4/6 inhibitors in patients with metastatic breast cancer.

Condorelli R, Spring L, O'Shaughnessy J, Lacroix L, Bailleux C, Scott V, Dubois J, Nagy RJ, Lanman RB, Iafrate AJ, Andre F, Bardia A.

Ann Oncol. 2018 Mar 1;29(3):640-645. doi: 10.1093/annonc/mdx784.


Overall survival in MERiDiAN, a double-blind placebo-controlled randomised phase III trial evaluating first-line bevacizumab plus paclitaxel for HER2-negative metastatic breast cancer.

Miles D, Cameron D, Hilton M, Garcia J, O'Shaughnessy J.

Eur J Cancer. 2018 Feb;90:153-155. doi: 10.1016/j.ejca.2017.10.018. Epub 2017 Nov 23. No abstract available.


Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial.

O'Shaughnessy J, Petrakova K, Sonke GS, Conte P, Arteaga CL, Cameron DA, Hart LL, Villanueva C, Jakobsen E, Beck JT, Lindquist D, Souami F, Mondal S, Germa C, Hortobagyi GN.

Breast Cancer Res Treat. 2018 Feb;168(1):127-134. doi: 10.1007/s10549-017-4518-8. Epub 2017 Nov 21.


A preclinical evaluation of the MEK inhibitor refametinib in HER2-positive breast cancer cell lines including those with acquired resistance to trastuzumab or lapatinib.

O'Shea J, Cremona M, Morgan C, Milewska M, Holmes F, Espina V, Liotta L, O'Shaughnessy J, Toomey S, Madden SF, Carr A, Elster N, Hennessy BT, Eustace AJ.

Oncotarget. 2017 Jul 22;8(49):85120-85135. doi: 10.18632/oncotarget.19461. eCollection 2017 Oct 17.


Understanding cardiopulmonary resuscitation.

Masters BJ, Mandeir J, O'Shaughnessy J, Sundar S.

J Pediatr. 2017 Nov;190:291-292. doi: 10.1016/j.jpeds.2017.07.031. No abstract available.


Epidemiological investigation of a severe rumen fluke outbreak on an Irish dairy farm.

O'Shaughnessy J, Garcia-Campos A, McAloon CG, Fagan S, de Waal T, McElroy M, Casey M, Good B, Mulcahy G, Fagan J, Murphy D, Zintl A.

Parasitology. 2018 Jun;145(7):948-952. doi: 10.1017/S0031182017002086. Epub 2017 Nov 16.


Hybrid capture-based genomic profiling of circulating tumor DNA from patients with estrogen receptor-positive metastatic breast cancer.

Chung JH, Pavlick D, Hartmaier R, Schrock AB, Young L, Forcier B, Ye P, Levin MK, Goldberg M, Burris H, Gay LM, Hoffman AD, Stephens PJ, Frampton GM, Lipson DM, Nguyen DM, Ganesan S, Park BH, Vahdat LT, Leyland-Jones B, Mughal TI, Pusztai L, O'Shaughnessy J, Miller VA, Ross JS, Ali SM.

Ann Oncol. 2017 Nov 1;28(11):2866-2873. doi: 10.1093/annonc/mdx490.


Erratum to: Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial.

Cortés J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J.

Breast Cancer Res Treat. 2017 Nov;166(1):327-328. doi: 10.1007/s10549-017-4482-3. No abstract available.


Ixabepilone and Carboplatin for Hormone Receptor Positive/HER2-neu Negative and Triple Negative Metastatic Breast Cancer.

Osborne C, Challagalla JD, Eisenbeis CF, Holmes FA, Neubauer MA, Koutrelakos NW, Taboada CA, Vukelja SJ, Wilks ST, Allison MA, Reddy P, Sedlacek S, Wang Y, Asmar L, O'Shaughnessy J.

Clin Breast Cancer. 2018 Feb;18(1):e89-e95. doi: 10.1016/j.clbc.2017.07.002. Epub 2017 Jul 10.


The molecular landscape of high-risk early breast cancer: comprehensive biomarker analysis of a phase III adjuvant population.

Wilson TR, Yu J, Lu X, Spoerke JM, Xiao Y, O'Brien C, Savage HM, Huw LY, Zou W, Koeppen H, Forrest WF, Fridlyand J, Fu L, Tam R, Schleifman EB, Sumiyoshi T, Molinero L, Hampton GM, O'Shaughnessy JA, Lackner MR.

NPJ Breast Cancer. 2016 Jul 13;2:16022. doi: 10.1038/npjbcancer.2016.22. eCollection 2016.


Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials.

Shapley S, O'Shaughnessy J, Woodcock J.

Ther Innov Regul Sci. 2017 Jul;51(4):416-418. doi: 10.1177/2168479017701801. Epub 2017 Apr 16.


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