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ABRCC: The Academic Breast Cancer Consortium

 

Press Release

Available for Immediate Release
Contact: Claire R. Wynters, Public Relations & Media (518) 583-0095 or
criteriumcontact@criteriuminc.com

CRITERIUM, Inc. Global CRO's ABRCC Presents Poster at SABCS 2017 for "TULiP" Trial

Elena Shagisultanova, MD, PhD, Assistant Professor at the University of Colorado Denver Cancer Center and Lead Principal Investigator of the TULiP trial presented a trials-in-progress poster summarizing the study design for the ongoing trial in patients with hormone receptor positive and HER2-positive (HR+/HER2+) metastatic breast cancer. In this study, tucatinib, a highly selective inhibitor of HER2 tyrosine kinase, is combined with an aromatase inhibitor letrozole and CDK4/6 inhibitor palbociclib. The TULiP study is expecting to enroll 40 patients. It is currently opened for enrollment at the University of Colorado Denver, and soon will be opened at five additional academic institutions (members of Academic Breast Cancer Research Consortium): North Western University, Chicago, IL; University of Texas Health and Science Center at San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ, and University of New Mexico, Albuquerque, NM. The Phase 1b part of the trial is expected to enroll 20 patients and will evaluate the tolerability of tucatinib given at maximum tolerated dose (300mg by mouth twice a day) with the standard doses of palbociclib and letrozole. The Phase 2 part of the trial is expected to enroll 20 additional patients to enable analysis of efficacy by overall response rate and progression-free survival. Because of documented activity of tucatinib in the CNS disease, the TULiP trial will include patients with brain metastases. For more information, visit ClinicalTrials.gov, Identifier: NCT03054363.

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About Criterium

Criterium, Inc. is a full-service, global CRO (contract research organization) that offers a unique mix of high-quality clinical research services and communication processes for the biopharmaceutical, pharmaceutical, and medical device industries to manage trials from initial planning to approval. Founded in 1991, Criterium's services are customized to fit each client's specific needs, providing a seamless flow of data and information from the investigative site through Criterium and back to the sponsor - 24/7, in real-time. Criterium's experienced team manages and implements clinical trials using technology-based solutions. Dedicated clinical professionals are committed to providing personal service and to forming strong and productive relationships with clients. Criterium's well-established staff are trained according to ICH GCP guidelines.

The Oncology Consortia of Criterium The Oncology Consortia of Criterium Global CRO are a collaboration of outstanding Cancer Research Consortia that deliver innovative research and unparalleled expertise: The Academic GI Cancer Consortium (AGICC) is presently represented by Key Opinion Leaders (KOLs) and top Investigators at 16 of the most prestigious institutions in the USA. The Academic Myeloma Cancer Consortium (AMyC) is represented by Key Opinion Leaders (KOLs) and top Investigators at 9 of the most prestigious institutions in the USA. The Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC) is represented by Key Opinion Leaders (KOLs) and top Investigators at 12 of the most prestigious institutions in the USA. The Academic Breast Cancer Consortium (ABRCC) is represented by Key Opinion Leaders (KOLs) and top Investigators at 14 of the most prestigious institutions in the USA.

Corporate headquarters are located in Saratoga Springs, New York with satellite offices in Florida & California, and in-country representation in South Africa, India, Canada, The EU, Israel, and Russia. This multi-national approach enables Criterium to provide time- and cost-efficient study management and monitoring to all our clients. To learn more about Criterium, visit the website www.criteriuminc.com.

 

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