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OSU To Open New TNBC Clinical Trial

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URL: http://forum.tnbcfoundation.org/forum_posts.asp?TID=11506
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Topic: OSU To Open New TNBC Clinical Trial
Posted By: 123Donna
Subject: OSU To Open New TNBC Clinical Trial
Date Posted: Sep 12 2013 at 3:28pm
OSU to open new triple negative breast cancer study; Cleveland Clinic, UH and 6 others also to enroll patients

CLEVELAND, Ohio -- By the end of the month, the  http://cancer.osu.edu/Pages/index.aspx" rel="nofollow - Ohio State University James Cancer Hospital  will open a Phase 2 clinical trial to test two drugs for the treatment of http://blog.cleveland.com/health/2008/06/absence_of_key_proteins_makes.html" rel="nofollow - triple negative breast cancer  -- a very aggressive type of cancer with high rates of recurrence.

The trial, developed and led by oncologist  http://internalmedicine.osu.edu/medicaloncology/directory/emacrae/index.cfm" rel="nofollow - Dr. Erin Macrae , will test two drugs that are taken together. Earlier this year the U.S. Food and Drug Administration approved one of the drugs, trafetinib, for the treatment of advanced melanoma. The other drug is a study drug. Both were developed by drug manufacturer http://us.gsk.com/" rel="nofollow - GlaxoSmithKline . 

An earlier Phase 1 trial at another cancer center has already established that the drugs are safe to use in humans. This new trial is studying to see what effects, if any, the drugs have on patients and their cancer.

“There is no ‘routine’ triple negative disease,” said Macrae, an oncologist at OSU's  http://cancer.osu.edu/patientsandvisitors/guide/outpatient/james_care_comprehensive_breast_center/pages/index.aspx" rel="nofollow - Stephanie Spielman Comprehensive Breast Center  and a graduate of the  http://casemed.case.edu/" rel="nofollow - Case Western Reserve University School of Medicine . “With other [breast cancer types] we can give targeted therapy. We can’t with this one.”

Triple negative breast cancer, which accounts for 15 to 20 percent of breast cancers, is so hard to treat because it doesn’t have any of the receptors (substances found inside cells that give rise to cancer) that existing drugs are able to fight. Triple negative gets is name from its lack of three hormone receptors -- estrogen, progesterone and HER2.

Researchers hope the two drugs being studied are effective targeted therapies.

“This is one of the most exciting scientific approaches that we have moved forward with in patients with triple negative breast cancer,” said Macrae, who will serve as the primary investigator for the entire trial.

Many other cancer centers have expressed interest in offering the trial to their patients, she said.

Up to 40 patients will be enrolled in the trial. Along with OSU, eight other sites across the country – including the  http://my.clevelandclinic.org/cancer/default.aspx" rel="nofollow - Cleveland Clinic Taussig Cancer Institute  and http://www.uhhospitals.org/seidman" rel="nofollow - University Hospitals Seidman Cancer Center  – will offer the trial.

The trial is sponsored by the  http://www.cancer.gov/" rel="nofollow - National Cancer Institute . For information on this or other cancer clinical trials, people can call OSU at 614-293-4376; the Clinic at 866-223-8100; or UH at 800-641-2422.

http://www.cleveland.com/healthfit/index.ssf/2013/09/new_triple_negative_breast_can.html" rel="nofollow - http://www.cleveland.com/healthfit/index.ssf/2013/09/new_triple_negative_breast_can.html



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DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15




Replies:
Posted By: 123Donna
Date Posted: Oct 02 2013 at 2:30pm

This is a Stage 2 Trial for mets.  The drugs are Trametinib and GSK2141795, both are given in pill form, 28 day cycle.  If you need more information, call Robyn Patrick 614-293-0194.


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DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15




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