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Efficacy and Tolerability of Trastuzumab-Emtansine in Elderly Patients with Advanced Breast Cancer; A Combined Analysis
Proposal
5501
Title of Proposed Research
Efficacy and Tolerability of Trastuzumab-Emtansine in Elderly Patients with Advanced Breast Cancer - A Combined Analysis
Lead Researcher
Noam Pondé
Affiliation
Institut Jules Bordet
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
28 Jan 2019
Lay Summary
A large proportion of patients diagnosed with metastatic breast cancer are elderly. Little is known, however about the effects and side effects of commonly used drugs. T-DM1 is a drug currently in use for a subtype of breast cancer called HER2+, which represents about 20% of total breast cancers diagnosed. T-DM1 has not been tested, however, in trials focusing specifically in elderly patients and thus little is known about the efficacy and tolerability of T-DM1 in elderly patients. As every trial in which T-DM1 was tested included a small number of elderly patients, by combining them, it will be possible to better investigate this. It is therefore the goal of this projects to investigate the efficacy and tolerability of elderly patients, defined as those with 65 years of age or older, focusing specifically on how important issues such as the existance of comorbidities and the use of multiple medications influence the efficacy and tolerability of T-DM1 in this population.
Study Data Provided
[{ "PostingID": 1364, "Title": "ROCHE-TDM4374g", "Description": "A Phase II, single-arm, open-label study, of Trastuzumab-MCC-DM1 adminstered intravenously to patients with HER2-positive metastatic breast cancer" },{ "PostingID": 1365, "Title": "ROCHE-TDM4258g", "Description": "A phase II, single-arm, open-label study of Trastuzumab-MCC-DM1 administered intravenously to patients with HER2-positive metastatic breast cancer who have progressed while receiving HER2-directed therapy" },{ "PostingID": 1366, "Title": "ROCHE-TDM4688g", "Description": "A phase II, open-label study to evaluate corrected QT interval effects of Trastuzumab-MCC-DM1 (T-DM1) in patients with HER2-positive recurrent locally advanced or metastatic breast cancer and to evaluate the safety and tolerability of combined T-DM1 and Pertuzumab in patients with early disease progression while receiving T-DM1 alone." },{ "PostingID": 2573, "Title": "ROCHE-BO21976", "Description": "A randomized, multicenter phase II study of the efficacy and safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin) and Docetaxel (Taxotere) in patients with metastatic HER2-positive breast cancer who have not received prior therapy for metastatic disease." },{ "PostingID": 2574, "Title": "ROCHE-BO21977", "Description": "A randomized, Multicenter, Phase III Open-Label study of the efficacy and safety of Trastuzumab-MCC-DM1 vs. Capecitabine + Lapatinib in patients with HER2-Positive locally advanced or metastic breast cancer who have received prior Trastuzumab-based therapy." },{ "PostingID": 4550, "Title": "ROCHE-BO22589", "Description": "A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer" },{ "PostingID": 4551, "Title": "ROCHE-BO25734", "Description": "A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy" }]
Statistical Analysis Plan
Publication Citation
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