Bisphosphonates Clinical Trial |
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123Donna 
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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 Topic: Bisphosphonates Clinical TrialPosted: Nov 01 2009 at 5:07pm |
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I'm posting this as a new topic since the "Search" button doesn't appear to be working anymore. I know we've had a couple of threads talking about this trial.
I'm will be starting the trial this month. I know it's currently closed to one of the arms (Boniva), so my options will be randomized into either the Zometa or Clondronate arm. I was telling my friend about the study and she asked if Boniva is an FDA approved drug, why not just have the onc prescribe Boniva and not participate in the trial since the other 2 drugs are not FDA approved yet? Does anyone know if there has been any information released from the study whether they consider one of the 3 drugs superior to the others? I know this is the purpose of the trial, but I'm kind of wondering what are the advantages of participating in the trial vs using a drug currently on the market. Any thoughts or insight would sure help me make a decision. Thanks, Donna |
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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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outnumbered
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Joined: Feb 02 2009 Location: New Jersey Status: Offline Points: 525 |
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Posted: Nov 01 2009 at 5:22pm |
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Hi Donna,
This is only a guess, not based on anything I have read, but Boniva is approved for osteoporois not for BC. Same for Fosomax. Zometa is approved for BC and Reclast is the same as Zometa, but it is approved for osteoporosis. To use Boniva or Fosomax for BC would be off label.
Hope that helps, don't know if that is the reason for the trial or not, but perhaps.
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~Sara
DX @ age 40 6/24/08 Stage 1 Grade 3 BRCA1+ 187delAG BMX (nipple-areola-sparing) 8/5/08 Redo BMX (remove nipple and areola) w/ Lat Flap 7/6/09 BSO 9/3/09 NED since 08/05/2008 |
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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 01 2009 at 6:29pm |
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Thanks Sara.
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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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unklez
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Posted: Nov 01 2009 at 6:34pm |
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Dear Donna,
We have the same questions!!! The answers that we have found so far: 1. Dose of bisphosphonates for BC is 10 times that for Osteoporosis. The doctors would very likely not prescribe them to you at the levels recommended in the BC trial. The advantage of participating in the trial is that you get monitored more frequently for bone mets. With close to 400 centers participating in this trial, you will most likely find a doctor near you that's participating. But if you choose to not participate, the drugs are not that expensive and relatively safe enough that you could get them in grey market (shipped from Canada) for $200 a month or so. The risk of Osteo Necrosis of Jaw (ONJ) is less than 0.5%. A dental checkup and clearance from the dentist before starting the treatment would reduce that risk even further. 2. Yes the Boniva arm is closed. Apparently Roche did not want to pay for any more drug for this trial. 3. No information has been released from this study on the relative superiority of 1 drug vs other. 4. Zometa needs to be taken by IV once a month for 6 doses and then once in 3 months for 10 doses. Clodronate needs to be taken by mouth daily for 3 years. It needs to be taken empty stomach and patient needs to stay upright for 1 more hour after taking it. 5. A German clinical trial of clodronate vs placebo indicates significant improvement in DFS @ 3 years and 4 1/2 years but not at 8.5 years. The OS was significantly improved at 8.5 years. See http://annonc.oxfordjournals.org/cgi/content/abstract/19/12/2007. The last line in the publication under the "results" heading can be misleading until you look deeper into the data. 6. A Korean clinical trial of Zometa vs placebo in patients with metastatic disease indicates that compared to ER/PR+ patients, the ER/PR- patients benefit much more and have significant improvement in OS from bisphosphonates. See http://www.biomedcentral.com/1471-2407/9/154. 7. A Finnish lab study in mice (not humans!) showed significant improvement when Zometa was given the day after Adriamycin. But in that study, both Zometa and Adriamycin were given at much higher doses than given for BC. 8. We asked DW's onco last week and she said she would recommend this trial. The hospital's research nurse emailed us yesterday and indicated that they are accruing for the trial (SWOG 0307). Good luck and keep us posted on what you decide. We will most likely enroll and start the bisphosphonates treatment sometime during the Taxol + Avastin/Placebo part of DW's chemo. |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 01 2009 at 7:15pm |
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Unklez,
Thanks for the information and research. I've printed it out. It never occurred to me that the dosage might be different for osteoporosis vs bc. My onc also recommended the trial to me and the breast center that I go to participates in the trial. Just knowing that I'll be monitored more closely gives me some reassurance. My dentist has cleared me for the trial. I'm having exchange surgery tomorrow morning and plan on joining the trial after I get the drain tubes removed. I want to thank you and all my TNBC friends. I've learned so much from this site, much more than I would ever been told by the medical community. Donna |
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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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Donna Z
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Joined: Nov 01 2009 Location: B.C., Canada Status: Offline Points: 129 |
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Posted: Nov 01 2009 at 9:02pm |
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Hello to all
I have asked oncology here at MDAnderson and they encouraged me to get in this trial. They said they will likely have their answer on whether zometa or clondronate is better or possibly they are equally good. There is a slightly higher risk with necrosis of the jaw with zometa however it is still less that 1%. I went to see a dental specialist and they said where you get into trouble is if you have to have a tooth extracted. So keep up with good dental care and checkups. You are also required to have a dental checkup and xrays within the 6 months prior to enrolling. They said fillings and root canals would not increase your risks. The bisphosphonates hang around for like 10-15 years in your bones even after you discontinue them. I also went to grand rounds on bisphosphonates and make sure you take them with a full glass of water and stay upright for an hour as they can burn a hole in your esophagus (their words). Do not take an antacid with them or they will not be absorbed, must be taken on an empty stomach and nothing but water for a full 30 minutes following. I am sure anyone getting on them will be given these full instructions. This trial is presently on hold in Canada awaiting ethics approval on an amendment. I was told it was so they could enroll even more people. There is a deadline; you must be enrolled by 3 months postop if you have had neoadjuvent chemo so keep this in mind if you are looking at the trial. So for me if it is not approved by Dec 3rd I would not be eligible however the onc said they would order either of the drugs for me. Zometa is $700 per month and not sure what clondronate is in Canada however many insurance plans like Blue Cross may pay. Mine would pay for it. Donna
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Dx 03/09 TN, Stg 2a, gr 3, 1.7 cm Taxol X 12, FAC X 4, segmental mastec Sept 10/09,
1 pos/29, from Canada, Treatment MDAnderson, rads X 30 started Oct 29/09. Zometa start Nov 24/09 |
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123Donna
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Posted: Nov 01 2009 at 9:20pm |
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Donna Z,
Great info. The other criteria for the trial is within 8 weeks of finishing chemo. So for me, my deadline is Nov 19th. Donna |
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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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unklez
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Posted: Nov 01 2009 at 10:21pm |
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DonnaZ,
Thanks for the info. |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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bookbaroness
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Joined: Oct 02 2009 Status: Offline Points: 52 |
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Posted: Nov 06 2009 at 3:56pm |
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Unkle Z and Donna,
Thanks for the info. I posted a question regarding this study in another thread, but this greatly helps me in deciding to go for this trial... I am so glad you guys are out there!!! diane |
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dx 3/09,lumpectomy 4/09, margin & axil nodes 5/09, stg IIa,grade 3.ACT/avastin done 10/29, rads started 11/30, 12/09 recur vs missed initially. 1/10 bilat mast, rads done 4/10, zometa q3mos now
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123Donna
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Posted: Nov 06 2009 at 4:42pm |
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Diane, UnkleZ, DonnaZ, and Sara,
Next week I'm going to call the clinical trial study coordinator at my onc's office for S0307, Phase III Trial of Bisphosonates as Adjuvant Therapy for Primary Breast Cancer. I had my exchange surgery this week and have been taking it easy recovering. When I spoke to the coordinator prior to my surgery she said they'll run some tests: CBC, Metabolic Panel, Liver Function Test, Kidney Function Test and a Creatin Test. She mentioned that they will do a CAT Scan of the Abdomen if the Liver test is elevated. I'll let you know if any of this information is different after I talk to her next week. Donna |
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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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Donna Z
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Posted: Nov 06 2009 at 5:17pm |
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Thx so much Donna 123. I am at MDAnderson and if they have any spots left for enrolling in this trial I will get on it here. Let us know any information at all that you find out. If I cannot get into the study I will be getting on clondronate or zometa and will ask the onc here if they have any recommendations when I see him Nov 23rd.
Donna Z
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Dx 03/09 TN, Stg 2a, gr 3, 1.7 cm Taxol X 12, FAC X 4, segmental mastec Sept 10/09,
1 pos/29, from Canada, Treatment MDAnderson, rads X 30 started Oct 29/09. Zometa start Nov 24/09 |
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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 06 2009 at 5:41pm |
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Donna Z,
Let us know if you hear anything after talking with your onc also. I feel I'll be monitored more closely and tested as a participant in the trial. Donna |
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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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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 11 2009 at 4:43pm |
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http://www.bcrfcure.org/action_scnews_gralow.html
This is an article from the Breast Cancer Research Foundation I read today. I pasted the link above, but if it doesn't work, it was located under their website Science News index. Edited by 123Donna - Nov 18 2009 at 8:05pm |
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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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unklez
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Posted: Nov 13 2009 at 11:14am |
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Dear 123 Donna,
So besides the blood tests (CBC, Metabolic Panel, Liver Function, Kidney Function Test and Creatin Test) and CT scan (was this bone scan or a whole body PET-CT do?), nothing else eg dentist checkup? I read that a dentist checkup from the last 6 months is ok. Did they ask for paperwork from dentist? Does enrolling in the trial prevent you from getting tooth extractions, wisdom teeth extraction, root canals, cleaning etc? |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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dmwolf
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Posted: Nov 13 2009 at 1:20pm |
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If you have any dental work that needs to be done, definitely do it before the trial starts. You can (and should) do cleanings, and an occasional filling is ok, but no tooth extractions or anything else that traumatizes bone during the trial. Jaw bone injury and bisphosphonates don't mix well. You need paperwork from your dentist - they will give you an evaluation form for him/her to fill out.
Good luck! Love, Denise (clodronate pill popper for one year so far with no ill effects) |
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DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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unklez
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Posted: Nov 13 2009 at 2:03pm |
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Denise, Thanks. We are planning to get the evaluation questionnaire from the oncologist, FAX it over to the dentist and get it back. She has some cavities etc that may need to be handled before start. |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 13 2009 at 3:04pm |
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Unklez,
Yes, you need a dental checkup prior to entering the trial. After finishing chemo in September, I had a dental checkup mid-October and talked to him about the trial. He said normal cleaning and fillings are OK while on the study, but its the teeth extraction that becomes difficult. My take is it is not something they would want to do while on the trial. They took x-rays as part of the exam and said my teeth were healthy and he may just want to see me more often (maybe go 3x a year instead of 2). The clinical trial contact person at my oncs office contacted my dentist and he sent over the necessary forms giving his approval and I guess copies of my dental records and/or xrays or anything else that was required for the study. I told you yesterday about getting the blood work for the trial. Well this morning I got a lovely wake up call telling me that I had elevated liver enzymes and they wanted to do a CT scan with contrast of my abdomen. She said the normal level should be between 0 - 31 and mine was 228. Oh joy, just what I needed, more to worry about. Of course they tell you "not to worry, its probably nothing". Yeah, like I can just switch the mind off! I'm hoping its just because of the chemo, then the breast exchange surgery 11 days ago and the anesthesia and medication. My onc should have the results either later this afternoon or Monday morning. Prior to my mastectomy surgery in June, I had a CT Chest Scan with Contrast. That scan turned out fine and they even mentioned that the visualized aspects of the liver are normal. I'm just praying that this will turn out to be nothing to worry about either. Donna |
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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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unklez
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Posted: Nov 13 2009 at 3:04pm |
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....
Edited by unklez - Nov 13 2009 at 3:37pm |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Nov 13 2009 at 3:11pm |
OK, were you just having a bad typing day??? |
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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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unklez
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Posted: Nov 13 2009 at 3:37pm |
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Lol. This is hilarious. It was our 3 year old.....I guess he has figured out how to point and click the mouse. I do apologize. I removed the characters since I could not delete that post :-)
Edited by unklez - Nov 13 2009 at 3:38pm |
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Wife Dx: Jul/09. Age: 37. Size: 3cm. BRCA: -ve. Lumpectomy: Aug/09. Micromet 1/9 node. Chemo Start: Sep/09. E5103. DD ACB-> DD Abraxane (Taxol reaction). Zometa (S0307). Canadian Fraction Rads.
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