Aphinity Clinical Trial

CENTER FOR DRUG EVALUATION AND RESEARCH
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: Figure 9: Confirmatory Trial APHINITY in the event that the confirmatory trial does not support the clinical benefit of pertuzumab after its accelerated approval ... Retrieve Full Source

DST Study Protocol Acronym Project Title Site Status Detail ...
Aphinity A randomized multicenter, double-blind, A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, CRC.6 A Phase III Trial of 6 Versus 12 Treatments ... Doc Retrieval

Surgery - AWS
Clinical Trials Reference List Surgery Title Phase Clinicaltrials.gov Identifier Principal Investigator/ (APHINITY) 3 NCT01358877 Hoffmann-La Roche A Randomized, Multicenter, A Phase II Randomized Clinical Trial Evaluating ... Doc Viewer

Neoadjuvant Pertuzumab: The Exception That Proves The Rule?
Neoadjuvant Pertuzumab: the Exception That Proves the Rule? In subsequent clinical trials, the key goals of neoadjuvant APHINITY trial (ClinicalTrials.gov identifier NCT01358877), which employed adjuvant pertuzumab for ... Retrieve Document

Clinical trials advancing the quest for cancer treatment, management, and prevention. ON THE Upcoming Events n CCRP Cancer Research Education Spring Meeting Dates The trial protocol and all accompanying documents, including the informed consent, ... Read More

Connections - ACCRU
AphiNity trial .. 5 Contact ACCRU.. 6 Connections Volume 1, No. 1 • Fall 2011 On Nov. 1, 2011, a in all stages of clinical trial development — from concept development to study implementation. As this relationship grows and develops, ... Document Retrieval

Newsletter Edition 30 Imagine - Breast Cancer Institute Of ...
Clinical trial APHINITY ahead of schedule. Close to 600 centres in 43 countries are participating in APHINITY and have recruited 4,688 women including 125 women from Australia and New Zealand. This clinical trial will ... Fetch Doc

List Of Actively Accruing Cancer Clinical Trials DST Study ...
List of Actively Accruing Cancer Clinical Trials Page 1 of 11 DST. Study: Protocol acronym: Aphinity A randomized multicenter, double-blind, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- ... View Document

José Baselga, MD, PhD - Research To Practice
José Baselga, MD, PhD You are the chair of the Phase III APHINITY trial, which randomly assigns DR LOVE: clinical resistance to trastuzumab has developed, allowing specific binding of the trastuzumab emtan-sine conjugate (T-DM1). ... Retrieve Full Source

What’s In Store At ASCO 2014? Kantar Health Offers A Preview ...
What’s in Store at ASCO 2014? Kantar Health Offers a Preview By Arnold DuBell, Ph.D., M.B.A. The annual meeting of the American Society of Clinical Oncology (ASCO) is nearing and Kantar Health has ELM-PC 5 (C21005) trial, which compared orteronel plus prednisone to prednisone plus ... Retrieve Document

ONCOLOGY DRUGS ADVISORY COMMITTEE MEETING Perjeta (pertuzumab)
ONCOLOGY DRUGS ADVISORY COMMITTEE MEETING when conventional clinical trial endpoints are used (i.e., EFS and OS). schema) in support of the initiation of the Phase III adjuvant trial, APHINITY. Three regimens were evaluated: ... Access Document

Conclusion From The Annual Meeting Of The Society Of Clinical ...
Conclusion from the Annual Meeting of the Breast Care 2012;7:336–340 Society of Clinical Oncology 2012 in Chicago – Expert Opinions Revisited ... Access Document

OTHER REVIEW(S) - Food And Drug Administration
The ongoing APHINITY trial, if positive, Clinical trial: any prospective investigation in which the sponsor or investigator determines the method of assigning investigational product or other interventions to one or more human subjects? 4. ... View This Document

DECATUR MEMORIAL HOSPITAL UPDATED: 05/07/98
DECATUR MEMORIAL HOSPITAL . IRB APPROVED ONCOLOGY PROTOCOLS . = Patients are no longer being enrolled to participate is specific portions of a clinical trial . On Hold APHINITY (DEC/EFF) (A.K.A. = BIG 4-11, BO25126, and TOC4939G) ... Read Content

HER2-targeted Therapy In Breast Cancer: A Systematic Review ...
Clinical trial setting but also in clinical practise. Longer follow-up of targeted therapy trials, and APHINITY (NCT01358877) are needed to establish the value of dual HER2 blockade on DFS and OS. In addition, the feasibility ... Access Full Source

Pertuzumab - Wikipedia, The Free Encyclopedia
Clinical trials. Early clinical trials of (Clinical Evaluation of Pertuzumab and Trastuzumab) trial was as follows: IV 840 mg loading dose followed by NEOSPHERE (early breast cancer), TRYPHAENA (HER2-positive stage II/III breast cancer) and APHINITY (HER2-positive nonmetastatic ... Read Article

Perjeta (pertuzumab) For Neoadjuvant Treatment Of HER2+ Early ...
Perjeta® (pertuzumab) for Neoadjuvant Treatment of HER2+ Early Breast Cancer and APHINITY • Genentech Clinical Advisory Boards CLEOPATRA trial (MBC) and other studies ... Access This Document

Newsletter - Swiss Group For Clinical Cancer Research
SaKK Newsletter September 29, 2011 5 The Swiss Oncology Research Network Trials Open for Accrual August 2011 disease group trial code trial title accrual ... Document Retrieval

PHARMACEUTICAL EXPO - INTERNATIONAL EVENT IN JULY - YouTube
PHARMACEUTICAL EXPO - INTERNATIONAL EVENT IN JULY aphinity 6.982 visualizações. 6:49 Exploiting favourable Clinical trial environment Biopharma Asia Convention - Duração: 35:56. biopharmachannel 188 visualizações. 35:56 ... View Video

Trial Protocol - AFFINITY Trial
Trial Protocol Version 2, 31 May 2012 . AFFINITY Protocol Version 2, 31 May 2012 2 Co-principal Investigators: Australian New Zealand Clinical Trial Registry number: ACTRN12611000774921 . AFFINITY Protocol Version 2, 31 May 2012 3 ... Access Doc