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Immune Therapy to Fight Cancer

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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Sep 04 2014 at 11:28pm
This is a Phase 1 Clinical Trial:

Bristol-Myers Squibb and Celgene Enter Clinical Collaboration Agreement to Evaluate Immunotherapy and Chemotherapy Combination Regimen

Phase I study to evaluate OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, with Celgene’s ABRAXANE® for multiple cancers

http://news.bms.com/press-release/rd-news/bristol-myers-squibb-and-celgene-enter-clinical-collaboration-agreement-evalua


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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 16 2014 at 11:38pm
Early clinical results with the drug, known as MPDL3280A, in so-called triple negative breast cancer will be revealed at the Dec. 9-13 San Antonio Breast Cancer Symposium.

Read more: http://www.businessinsider.com/r-roche-extends-immunotherapy-fight-to-breast-cancer-2014-10#ixzz3GMzySTew
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)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 18 2014 at 12:47pm
Merck and Roche are hoping to widen this novel approach to treat advanced triple negative breast cancer, which is notoriously impervious to some of the most effective therapies available for breast cancer, like hormone therapy and drugs that target HER2 receptors. The New Jersey-based drugmaker and Swiss company will present early clinical results at the San Antonio Breast Cancer Symposium in December, according to Reuters.

Roche's drug, MPDL3280A, has already posted encouraging results in bladder, lung and skin cancers though it's not yet approved to treat any indications. Meanwhile, Merck is studying how triple negative breast cancer patients fair with its PD-1 drug Keyruda, which won approval for melanoma and has shown promise in stomach and other cancers.

Bristol-Myers is also moving in on this target, with its August announcement that it will begin a Phase I breast cancer trial of its PD-1 drug nivolumab alongside Celgene ($CELG) Abraxane.

http://www.fiercebiotech.com/story/merck-and-roche-prep-breast-cancer-data-promising-pd-1-drugs/2014-10-17

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)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote kellly Quote  Post ReplyReply Direct Link To This Post Posted: Oct 18 2014 at 3:26pm
Thanks for sharing Donna! 
 Do you have any information on the trial?

DX '08,34yr, TN-IBC, gr3, 4 FEC, 3 Taxotere, biMST ->3/9 nodes+, 23rad's, BRCA-, bi DIEP '09. '12 son born!
Dx2 feb'14 mets subcl. & mediast. lymph nodes.CHEK2-. Olaparib, Carboplatin. Now: Nivolumab
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 18 2014 at 5:12pm
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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 23 2014 at 9:36pm
Keytruda, has already been approved by the FDA for treating advanced melanoma. However, the drug showed promise in treating other cancers including triple-negative breast cancer (TNBC). TNBC is difficult to cure because it does not usually improve after using traditionally effective treatments such as hormone therapy. Merck hopes to change that with Keytruda.

The drug works by inhibiting a protein called programmed death receptor 1 (PD-1), which negatively regulates immune response. Tumors use PD-1 to avoid cells that fight against diseases. PD-1 blockers are a new class of immunotherapy drugs.

 http://www.financialbuzz.com/merck-co-nyse-mrk-set-to-announce-breast-cancer-drug-results-in-december-market-news-166552

Keytruda will reportedly be the sixth most expensive drug on the market at a price of $12,500 per patient per month.

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Nov 12 2014 at 8:50pm
Caris Life Sciences Study Shows Molecular Profiling May Expand Use of PD-1 and PD-L1 Inhibitors to Wide Variety of CancersResults Published in Cancer Epidemiology Biomarkers & Prevention Demonstrate Utility of Caris Molecular Intelligence™ in Exploring Expression of Targetable Immune Proteins

More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=103630#.VGQKT_nF98E#ixzz3IuR7fS96
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)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2014 at 8:07am
PD-L1 and MEK inhibition may be synergistic in triple-negative breast cancer
MHC-I/II and PD-L1 expression appeared to have opposing effects on the immune system in patients with triple-negative breast cancer who had residual disease after neoadjuvant chemotherapy, according to study results presented at the San Antonio Breast Cancer Symposium.

These findings suggest that combined PD-L1 and MEK inhibition may have a synergistic antitumor effect in triple-negative breast cancer, researchers said.

“Increased tumor-infiltrating lymphocytes have been shown to predict favorable patient prognosis in triple-negative and HER-2–positive breast cancers in a variety of different disease states, including in the adjuvant setting,” Justin M. Balko, PharmD, PhD, assistant professor of medicine and cancer biology at Vanderbilt University in Nashville, Tenn., said during a presentation. “Increased tumor-infiltrating lymphocytes in pretreatment biopsies can also predict pathological complete response in the neoadjuvant setting, and in patients who lack a pathological complete response to neoadjuvant chemotherapy, increased tumor infiltrating lymphocytes in residual disease can predict improved RFS and OS.”

To read more:

http://www.healio.com/hematology-oncology/breast-cancer/news/online/%7Bf3d801cf-3605-40b6-a68f-775c712c7bc3%7D/pd-l1-and-mek-inhibition-may-be-synergistic-in-triple-negative-breast-cancer

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote CatWhispurrer Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2014 at 2:47pm
Thanks Donna.   Such exciting news.   I am in a different clinical trial for stage IV TNBC at Vanderbilt and so far, I have had complete response.    I am excited to see other alternatives being developed, especially less toxic ones!Thumbs Up
Found lump 9/16/11, age 55, Diagnosed 10/27 IDC TN, LX/SNB 12/7/11, Stage 1, Grade 3, 1.8 cm, 0/3 nodes, BRCA-, DD A/C on 1/23/12, followed by DD Taxol. 3/14/14 Stage IV, 3/26/14 Paclitaxel
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Post Options Post Options   Thanks (0) Thanks(0)   Quote katrinaS Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2014 at 8:13pm
Catwhispurrer,
What clinical trial are you in?  I have been in Roche/Genentech's MPDL3280A clinical trial for anti-PDL1 treatment and had a lot of progression on it and was taken off the trial.  Thank you,
Katrina
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2014 at 8:24pm
Early trial of new drug shows promise for patients with triple-negative breast cancer
In patients with metastatic triple-negative breast cancer—a disease with no approved targeted therapies—infusion of pembrolizumab produced durable responses in almost one out of five patients enrolled in a phase-Ib clinical trial, according to data presented Dec. 10, at the 2014 San Antonio Breast Cancer Symposium.

The multi-center, non-randomized trial was designed to evaluate the safety, tolerability and antitumor activity of bi-weekly infusions of pembrolizumab (MK-3475, marketed as Keytruda®). The researchers enrolled 27patients, aged 29 to 72 years, who had metastatic triple-negative breast cancer that either relapsed after treatment for early stage disease or progressed on therapy for advanced disease.

"For this group of patients our treatment options are limited to chemotherapy," said study director Rita Nanda, MD, assistant professor of medicine and associate director of the breast medical oncology program at the University of Chicago.

All patients in the study had triple-negative tumors with high levels of a protein called programmed death-ligand 1 (PD-L1). This protein can suppress the immune system's efforts to eliminate cancer cells. Pembrolizumab is a monoclonal antibody designed to help reactivate a person's own immune system to help fight the tumor.

"Pembrolizumab appears to make a significant difference for a subset of patients," Nanda said. "Of the 27 patients in this study with measurable disease, five (18.5%) had encouraging results. One patient had a complete response, and four had a partial response to treatment."

Responses for those five patients were long-lasting. Meanwhile, the patient with a complete response and two of those with a partial response continue to be treated with pembrolizumab.

An additional seven patients had stable disease, and twelve had progressive disease. Three patients left the trial early because their disease progressed.

Pembrolizumab, approved in September 2014 by the Food and Drug Administration for treatment of melanoma, does have some side effects. But Nanda said those are generally mild and easy to manage. They include fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain and diarrhea.

In this trial, four of the 27 patients experienced at least one severe or life-threatening drug-related adverse event. One patient died while on the study treatment.

"The median survival for patients with triple-negative breast cancer is approximately one year," Nanda said. "We need better treatments for this disease. The promising activity of pembrolizumab seen in PD-L1-expressing, triple-negative breast cancer is exciting, and certainly worthy of further investigation."

An important next step, she said, is to learn how to predict which patients are most likely to benefit and how to manage the drug's toxicity.

http://medicalxpress.com/news/2014-12-early-trial-drug-patients-triple-negative.html

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 12 2014 at 10:58pm
Results of the first phase I trials of programmed cell death 1 (PD-1) and PD-L1 inhibitors in breast cancer were presented at the 2014 San Antonio Breast Cancer Symposium (SABCS), held December 9–13 in San Antonio, Texas. - See more at: http://www.cancernetwork.com/sabcs-2014/immunotherapy-yields-response-triple-negative-breast-cancer#sthash.ecVKpD4V.dpuf

A phase II trial of pembrolizumab in patients with advanced triple-negative breast cancer is expected to start in the first half of 2015. - See more at: http://www.cancernetwork.com/sabcs-2014/immunotherapy-yields-response-triple-negative-breast-cancer#sthash.ecVKpD4V.dpuf

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote kellly Quote  Post ReplyReply Direct Link To This Post Posted: Dec 14 2014 at 8:11am
https://clinicaltrials.gov/ct2/results?term=pdl1+breast+cancer&Search=Search

two trials, both anti PDL1, but 2 different drugs.
so there are several anti pdl-1 drugs. what could be the difference between them? Donna do you know how that works?
DX '08,34yr, TN-IBC, gr3, 4 FEC, 3 Taxotere, biMST ->3/9 nodes+, 23rad's, BRCA-, bi DIEP '09. '12 son born!
Dx2 feb'14 mets subcl. & mediast. lymph nodes.CHEK2-. Olaparib, Carboplatin. Now: Nivolumab
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Post Options Post Options   Thanks (0) Thanks(0)   Quote CatWhispurrer Quote  Post ReplyReply Direct Link To This Post Posted: Dec 14 2014 at 10:23pm
Katrina - I am in a trial with Cisplatin and GDC-019 (Pi3K inhibitor) at Vanderbilt.
Found lump 9/16/11, age 55, Diagnosed 10/27 IDC TN, LX/SNB 12/7/11, Stage 1, Grade 3, 1.8 cm, 0/3 nodes, BRCA-, DD A/C on 1/23/12, followed by DD Taxol. 3/14/14 Stage IV, 3/26/14 Paclitaxel
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2014 at 8:27am
Pembrolizumab (MK-3475 - Keytruda)

In patients with metastatic triple-negative breast cancer--a disease with no approved targeted therapies--infusion of pembrolizumab produced durable responses in almost one out of five patients enrolled in a phase-Ib clinical trial, according to data presented at the 2014 San Antonio Breast Cancer Symposium.

The multi-center, non-randomized trial was designed to evaluate the safety, tolerability and antitumor activity of bi-weekly infusions of pembrolizumab (MK-3475, marketed as Keytruda®). The researchers enrolled 27 patients, aged 29 to 72 years, who had metastatic triple-negative breast cancer that either relapsed after treatment for early stage disease or progressed on therapy for advanced disease.

http://www.medicalnewstoday.com/releases/286848.php?tw

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote positive_attitude Quote  Post ReplyReply Direct Link To This Post Posted: Dec 18 2014 at 9:21pm
Is anyone familiar with CAR T-cell immune-therapy? It seems to be very successful for some other deadly cancers: http://www.cancer.gov/cancertopics/research-updates/2013/CAR-T-Cells. Someone said, "[The CAR T cells are] much more potent than anything we can achieve [with other immune-based treatments being studied]."

I also came across a trial of CAR-T for breast cancer. TNBC and metastatic BC can participate. Even newly diagnosed TNBC. Is anyone on this trial: https://clinicaltrials.gov/ct2/show/NCT01837602?

Rebecca


DX IDC TNBC May, 2014, 4.7cm, 5.8cm on Taxol. Taxol 4 weeks, AC 6. double mastectomy OCT 2014. 1.8cm residual in breast and 3mm a lymph node. BRCA-. 11/17 Abraxane,5FU.11/20, rads, 1/19 FUMEPx2
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 12 2015 at 8:13pm

OncoSec Medical Plans to Initiate Pilot Study in Triple Negative Breast Cancer

Study to Be Conducted at Stanford University

OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, plans to initiate a pilot study to assess IL-12 ImmunoPulse in patients with Triple Negative Breast Cancer (TNBC). The study will be conducted at Stanford University with Melinda L. Telli, MD, serving as lead investigator.

This pilot study is designed to assess whether IL-12 ImmunoPulse increases TNBC tumor immunogenicity by driving a pro-inflammatory cascade of events that leads to increases in cytotoxic tumor-infiltrating lymphocytes (TILs). The presence and number of TILs is thought to be a key requirement for promoting the anti-tumor activity of antibodies like anti-PD-1/PD-L1. By driving cytotoxic immune cells into the tumor, IL-12 ImmunoPulse may be an ideal candidate to combine with checkpoint blockade therapies which reported some activity in TNBC.

Worldwide, TNBC amounts to approximately 200,000 cases each year and accounts for approximately 20 percent of all breast cancer. It is most commonly diagnosed in younger women (less than 40 years) and is characterized by higher relapse rates when compared with estrogen receptor (ER)-positive breast cancers. TNBC is also associated with an increased risk of recurrence, both locally and in distant sites, including the lung and brain. Advanced TNBC remains a significant area of unmet medical need and there is no established standard-of-care. Treatment generally includes chemotherapy, with or without radiation and/or surgery. However, no treatment regimen has clearly demonstrated superiority.

Previous studies have reported that patients with TNBC tumors associated with markers of inflammation, such as the presence of tumor-infiltrating lymphocytes (TILs), have improved survival, and recent data presented have shown that TNBC is responsive to immunotherapies like anti-PD-1 or anti-PD-L1 checkpoint blockade drugs. Response rates in TNBC patients receiving either anti-PD-1 or anti-PD-L1 in early Phase 1 studies were reported to be 18 to 33 percent.

“The data presented at the 2014 San Antonio Breast Cancer Symposium (SABCS), combined with historical data correlating increased immunogenicity with improved survival in TNBC, strongly suggest that treatments aimed at augmenting pro-inflammatory signals within the tumor have a central role in improving the clinical outcomes for TNBC patients,” said Mai H. Le, Chief Medical Officer at OncoSec Inc. “We are very excited to be working closely with our colleagues at Stanford on this pilot clinical program, which is specifically designed to evaluate the role of IL-12 ImmunoPulse in promoting tumor immunogenicity in TNBC and, ultimately, improving patient outcomes.”

Dr. Robert H. Pierce, OncoSec’s Chief Scientific Officer, commented: “Both the Merck and Roche/Genentech studies presented at SABCS indicate that a distinct sub-population of TNBC patients respond to inhibition of the immunosuppressive PD-1/PD-L1 axis. Both independent studies support the emerging paradigm that the presence of ‘stalled’ CD8 T cells (so called ‘adaptive resistance’) drives the response to PD-1/PD-L1 therapeutics. We are excited that two experts in this field, Drs. Holbrook Kohrt (Stanford) and Paul Tumeh (UCLA), will be involved in analyzing our samples from this pilot study.”

http://www.businesswire.com/news/home/20150112005249/en/OncoSec-Medical-Plans-Initiate-Pilot-Study-Triple#.VLRxOSvF98E


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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Post Options Post Options   Thanks (0) Thanks(0)   Quote tripleneg-mom Quote  Post ReplyReply Direct Link To This Post Posted: Jan 25 2015 at 3:39pm
What a great thread with excellent information on immunotherapy.  I'm trying to get on an immunotherapy trial at MD Anderson but so far no luck.  It sounds so promising.  

I ran across the following article.  It's focused alot on melenoma but I found it interesting that some of these patient stories mention how it took awhile to actually see good results.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Lillie Quote  Post ReplyReply Direct Link To This Post Posted: Jan 25 2015 at 6:03pm
WOW!!
I watched the video of each person and have a feeling that the immunotherapy trial is a winner for melanoma.
The comment at the end from the man whose wife has stage 4 triple negative breast cancer really caught my eye. Wouldn't it be wonderful if it WORKS for us as well as for melanoma.

God Bless,
Lillie
Dx 6/06 age 65,IDC-TNBC
Stage IIb,Gr3,2cm,BRCA-
6/06 L/Mast/w/SNB,1of3 Nodes+
6/06 Axl. 9 nodes-
8/8 thru 11/15 Chemo (Clin-Trial) DD A/Cx4 -- DD taxol+gemzar x4
No Rads.
No RECON - 11/2015-9 yrs NED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Lillie Quote  Post ReplyReply Direct Link To This Post Posted: Jan 26 2015 at 7:45pm
Double WOW!
Guess what the topic of conversation was today at lunchtime. Melanoma, stage iv triple negative breast cancer and YERVOY.
A drug representative provided lunch for the doctors and staff. As I said the topic of conversation was YERVOY and a stage iv TN cancer patient. The oncologist and staff are hoping to get her insurance to give the go ahead with the Yervoy. I'm praying for NED for the lady who hopefully will be getting YERVOY.

God Bless,
Lillie
Dx 6/06 age 65,IDC-TNBC
Stage IIb,Gr3,2cm,BRCA-
6/06 L/Mast/w/SNB,1of3 Nodes+
6/06 Axl. 9 nodes-
8/8 thru 11/15 Chemo (Clin-Trial) DD A/Cx4 -- DD taxol+gemzar x4
No Rads.
No RECON - 11/2015-9 yrs NED
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