Bisphosphonates Clinical Trial - any info |
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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 Trial - any infoPosted: Sep 06 2009 at 5:54am |
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I asked my onc about clinical trials and she mentioned one that I might be interested in once I complete my chemo. I was wondering if any one else has participated in the trial or knows anything about it. I'm just doing some research now to see if it would be a good fit for me. My understanding is that the current trial is closed, but that it may be modified slightly and reopened in the fall.
The current trial name is SO307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer. This study is investigational and is being done to find out if adding a drug ( a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. "Bishposphonates" are a group of drugs that have strong efffects on the bones and have been show to strenthgthen the bones in many patients who take them. I'm a newer member to this forum and wanted to see if any of the other members can offer any advice. Thanks for any help, 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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Morgan513
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Posted: Sep 06 2009 at 9:32am |
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I'm currently enrolled in the Bisphosphonate trial. It's the three arm trial comparing different bisphosphonates and how they work. It's the Phase III. I am taking Ibandronate, once a day, every day. No side effects at all.
I've been hearing lots of positives about this trial so I am really happy to be a part of it.
Lorrie
DX 4/08, Stage 2a Medullary N0, M0. Lumpectomy, chemo (TC x 4), radiation.
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dmwolf
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Posted: Sep 06 2009 at 10:35am |
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In in the trial, too, on the Clodronate arm. It's a good trial in that there's no placebo arm. Everyone gets a bisphosphonate.
I haven't had any side effects that I can feel, although my liver enzymes elevated a bit for a while. The main risk with bisphosphonates is ONJ, osteo-necrosis of the jaw. It doesn't happen at very high incidence, at least at first (I think the longer you use it, and the more frequent/higher the dosing, the greater the risk), but if it does strike it is a real problem. Part of the jaw dies, and the damage is irreversible even after the drug is discontinued. Pretty horrible. I think ONJ is more likely with the IV version, Zometa, but it can strike with any of the drugs. Bisphosphonates appear to reduce the probability of recurrence in the first 5 years, though they may not reduce the long term probability (studies I've seen have recurrence curves that seem to converge at about the 10 year point). They are thought to be protective both locally, be making the bone less hospitable to growing metastases, and systemically, perhaps by an anti-angiogenic (blood supply) effect. So you'll have to balance the risks of ONJ vs recurrence and make a decision that 'minimizes regret' over all contingencies. I went on the trial because my tumor was pretty large and I didn't have a pCR, and therefore considered myself high risk. Had I either achieved pCR or begun as a stage I, I probably wouldn't have done it. Good luck deciding, love, d Edited by dmwolf - Sep 06 2009 at 10:37am |
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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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123Donna
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Joined: Aug 24 2009 Location: St. Louis, MO Status: Offline Points: 13510 |
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Posted: Sep 06 2009 at 11:00am |
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Thanks the information. Can you tell me what pCR means? I'm new and don't always understand all the abbreviations.
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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cg---
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Joined: Jul 20 2007 Location: Canada Status: Offline Points: 1379 |
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Posted: Sep 06 2009 at 12:59pm |
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I take clodronate 1600 mg a day, no side effects and I needed the extra added insurance policy since I have positive nodes. When I fall off the low-fat wagon (remember the Angus burger of July Denise?), I feel much better knowing the clodronate is doing a bit of backup work.
Love,
Connie
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Morgan513
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Posted: Sep 06 2009 at 1:19pm |
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OMG! Connie, I know exactly what you mean!
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Lorrie,DX 04/08, Stage 2A Medullary, N0, M0; Lumpectomy, Chemo (TC x4) and Radiation. Enrolled in Bisphosphonate Phase III study.
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Nancy
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Posted: Sep 06 2009 at 1:37pm |
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Dear Denise,
I had been on Fosomax for over 7 years, and decided to go off it, (actually the generic which I had been on for over a year), due to all the lawsuits from the dead jaw syndrome and then the deaths of 24 women due to esophegeal cancer. I stopped taking it in March.
When I went ot my GYN 2 weeks ago, she said she was going to take me off it anyway! DUH!! After so many years it "turns" on you, and once you take them even for a short amount of time they stay in your body for 10 - 20 years. They contain the same chemical compound which is used to make bathtub cleaners.
It has now been proven that all bisphosphnates "cause" your bones to become more brittle and are causing breaks. There is a book out called "The Truth about Fosomax", and many many articles proving this. Of course, I hesitate to post these, as it seems that if the article is not from the drug companies that no one believes them.
It amazes me that they are using women dx with bc as lab rats and know without a doubt the damage these drugs can do and are doing.
Love,
Nancy
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Nancy
DD Lori dx TNBC June 13,2007 Lumpectomy due to incorrect dx of a cyst mastectomy July 6 2007 chemo ACT all 3 every 3 weeks 6 tx Aug-Nov 28 rads ended Jan 2008 |
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Nancy
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Posted: Sep 06 2009 at 1:41pm |
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Dear Donna,
Did I send you all the information that I send to all the new members? If so, there are links in that for abbreviations, and much more. If you did not get all the info, please send me a pm and I will get that to you right away.
PCR means pathologically complete response
Hugs,
Nancy
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Nancy
DD Lori dx TNBC June 13,2007 Lumpectomy due to incorrect dx of a cyst mastectomy July 6 2007 chemo ACT all 3 every 3 weeks 6 tx Aug-Nov 28 rads ended Jan 2008 |
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Morgan513
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Posted: Sep 06 2009 at 2:25pm |
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Nancy,
I understand exactly where you are coming from in regard to the bisphosphonates. But, I decided to participate in the trial because there are no treatments for us TriNeg girls. If there is something that will give me extra assurance that I am doing all I can do to not have it come back, I'm all for it! I am young and able to take the meds as directed. Also, my mother had severe osteoporosis which was a preciptating factor in her early death. She had fractures of her spine, she was hunched over and all the meds in the world could not fix that.
I've addressed the calcium issue by taking more calcium supplements as recommended by a registered dietician at Dana Farber. There is evidence that bisphosphonates and cause low calcium thereby causing fractures for no obvious reason. Also, my Vitamin D has been upped to 2000 iu's a day.
I have an angel of a dentist who keeps tabs on me. I go for regular bloodwork to check kidney function too. All is great so far!
I hope you understand that it is a personal choice to take part in the study and that for ME, the positives out weigh the negatives.
Lorrie
Edited by Morgan513 - Sep 06 2009 at 2:27pm |
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Lorrie,DX 04/08, Stage 2A Medullary, N0, M0; Lumpectomy, Chemo (TC x4) and Radiation. Enrolled in Bisphosphonate Phase III study.
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123Donna
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Posted: Sep 06 2009 at 2:42pm |
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Nancy:
Thank you, yes, I received the abbreviations you sent me as a new member. I guess I'm unclear about what PCR actually means. Does that mean that the complete path report wasn't available yet? Or that the path report didn't contain all the information needed. I aplologize, I just didn't understand the conversation in reference to PCR. Sorry. 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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cg---
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Joined: Jul 20 2007 Location: Canada Status: Offline Points: 1379 |
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Posted: Sep 06 2009 at 3:07pm |
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Dear Donna,
PCR - Pathologic Complete Response
Those are some of our favor words in the world of TNBC - that means the chemotherapy made your tumor shrink and disappear!
That is why I think it should be a standard that since chemotherapy is our treatment 'big gun' we should know if the chemotherapy works and if it does not then we have to try another one. The tumor must still be present and chemotherapy before surgery is called neoadjuvant chemotherapy - after the surgery it is adjuvant chemotherapy.
But the most beautiful NED...No Evidence of Disease.
Love,
Connie
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Nancy
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Posted: Sep 06 2009 at 3:22pm |
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Dear Lorrie,
I understand completely, however, calcium and bisphosphonates are not what build strong bones. It is the D3 and all your hormones being balanced which accomplish that. If your immune system is compromised that also contributes to many diseases, including osteoporosis.
I am so sorry to hear that your mom had osteoporosis, and I have known many women, (many who I had the priviledge to care for), who also had this condition.
As to 2000 iu's of D3 a day? Wow! That is a very low dosage for someone dx with bc. In the articles which I have been reading, you should be on at least 5000 to 10,000 a day. What are you D levels? They shoud be in the upper 80's and even higher, according to the vitamin D council, and most doctors do not have a clue that is what they should be. The correct test is not even being run to determine the D levels. One other thing, if you are not taking Magnesium, then you body is not absorbing the D3.
Once you have the dead jaw syndrome there is no stopping it, so bless your dentist for keeping tabs on you, but there is nothing he or anyone can do to stop it once you have the dx. I will now worry about myself and if it happens...it happens, but I was negligent for not looking into this sooner than I did. The lawsuits have been ongoing for years now, and I am positive there will be hundreds of thousand more, and what is so sad is that they will be all women.
I was having difficulty swallowing and the bone pain was getting worse.
Now I can swallow 4 vitamins at a time. Bone pain is subsiding, and I have now upped my D to 4000 a day.
I see where you went or are going to a registered dietician at Dana Farber, but I would suggest that you do some researching on your own, just as I did.
When I went to my GYN 2 weeks ago, she began telling me then about another drug...Forteo, but you give yourself shots in the stomach. ( I DON'T THINK SO!!!!)
 Oh...and you can only take it for a determined period of time. Gee! Really?As I sat on the examining table, with my gown on and swinging my legs. I listened to her explaining the benefits of this drug. I know that my grin got wider and wider, and finally she put up her hand and said....I am just giving you the information...whatever you decide is your decision and yours alone. I know you will go home and look it up on the internet!!
 I just flat out said...nope I am not going to take it or for that matter any drug!! I have also refused to get a mammogram, as that squishing hurts my breasts for days. My sister had a mammo 3 weeks ago, and her one breast was completely black and blue, and under her arm, and she has bruised muscles in her back.
Lorrie, there are side effects to every med...every one of them, but when the drug companies know/knew what a particular med could/can do, and have the money and attorneys all lined up to take care of the lawsuits, that speaks volumes to me!! There are many meds which have saved lives, and for them I am very grateful, but some are not worth the risk.
Love and hugs,
Nancy
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Nancy
DD Lori dx TNBC June 13,2007 Lumpectomy due to incorrect dx of a cyst mastectomy July 6 2007 chemo ACT all 3 every 3 weeks 6 tx Aug-Nov 28 rads ended Jan 2008 |
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Morgan513
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Posted: Sep 07 2009 at 7:23am |
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I just came upon a link that said the trial is suspended pending a signficant change in protocol.
I'm furious that my doctor and trial nurse didn't tell me!
Lorrie
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Lorrie,DX 04/08, Stage 2A Medullary, N0, M0; Lumpectomy, Chemo (TC x4) and Radiation. Enrolled in Bisphosphonate Phase III study.
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sberger
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Posted: Sep 24 2009 at 10:02am |
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HI,
I asked my onc if the Fosamax I'm taking would help me. She said that you need a higher dose and told me to tell my doctor to give me Zometa intravenous. She said since I have osteoporosis, I should take a dose that might also help prevent a recurrance. That made a lot of sense to me.
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DX 10/06
Stage 2-3,Grade 3,3.5cm 2 nodes +, lymphvascular invasion, 2 Avastin + Cisplatin, Mastectomy, clear lymphvascular, AC+Avastin * 4,Taxol + Avastin just once because of toxicity, Rads 5 wks. |
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123Donna
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Posted: Sep 24 2009 at 7:59pm |
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Lorrie:
My onc just told me the trial has been reopened, but with just 2 of the arms: 1) zoledronic acid (IV) and 2) Clodronate daily by mouth. I'm trying very hard to make a decision on participating in this trial. I know I have a short time to enter the trial. I'm going to do further research and visit my dentist soon for his opinion. 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: Sep 25 2009 at 5:20am |
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I found this article from Cancer Consultants website. (I tried to make the link hot, but it didn't work)
http://www.cancerconsultants.com/denosumab-more-effective-than-zometa-in-breast-cancer-patients-with-bone-metastases/ Denosumab More Effective Than Zometa in Breast Cancer Patients with Bone MetastasesSeptember 22, 2009
Among women with bone metastases from breast cancer, denosumab was more effective than Zometa® (zoledronic acid) at delaying or preventing bone complications such as fracture. The results of this Phase III clinical trial were presented at a major European cancer conference. Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including breast cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression, and may require treatment with surgery or radiation therapy. Bisphosphonate drugs such as Zometa are commonly used to reduce the risk of complications from bone metastases. Researchers continue, however, to explore new approaches to treatment. Denosumab is an investigational drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Denosumab has shown promising results in the management of patients with bone metastases as well as the management of bone loss due to cancer treatment. To directly compare denosumab to Zometa among breast cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled more than 2,000 patients. Study participants were assigned to receive either denosumab or Zometa. The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.
The results of this study suggest that denosumab may be more effective than Zometa at delaying or preventing skeletal complications in breast cancer patients with bone metastases. Reference: Stopeck A, Body JJ, Fujiwara Y et al. Denosumab versus zoledronic acid for the treatment of breast cancer patients with bone metastases: results of a randomized phase 3 study. Presented at the Joint ECCO 15-34th ESMO Multidisciplinary Congress. Berlin, Germany, September 20-24, 2009. Abstract 14LB |
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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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Nancy
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Joined: Jul 23 2007 Location: Altoona, PA Status: Offline Points: 3814 |
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Posted: Sep 25 2009 at 6:11am |
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Nancy
DD Lori dx TNBC June 13,2007 Lumpectomy due to incorrect dx of a cyst mastectomy July 6 2007 chemo ACT all 3 every 3 weeks 6 tx Aug-Nov 28 rads ended Jan 2008 |
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EileenF
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Posted: Feb 12 2010 at 1:53pm |
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Hi
I just started the clinical trial using zoledronic acid (IV). The day after the infusion I work up with a low fever and flu like symptons which were easily relieved by xstrenght tylenol. However the week after the infusion I woke up with a rash all over my body (limbs, stomach, neck, face) and blood shot eyes. I look like an extra from a horror movie LOL. My onc has me taking benadryl, precription eye drops and using hydrocortozone cream for the itching. She reported the reaction to the drug company and they all agreed I could go ahead with the next IV infusion March 4th, receiving IV benadryl before giving me the zoledronic acid. If the rash occurs again, they will remove me from the trial. This has me very worried. After my bilat masectomy, there was some residual cancer cells left, which the breast surgeon assured me the radiation would take care of (I start radiation Feb. 15th).
Has anyone else had an adverse reaction to taking the zoledronic acid? I am worried about being removed from the trial as TNBC is so agressive and I am not sure the diet and exercise changes I am making will be enough to stop a reoccurence.
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7/09:IDC,stg 3,Grade3, pos lymph;chemo ACT;12/09 lumpect n lymp disect;1/10 bilat masect/tis exp; rad cmpltd 4/10; 11/10 stg 4 lungs chest axil mets & parp trial;3/11 IBC diag;
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123Donna
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Posted: Feb 12 2010 at 2:52pm |
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Eileen,
Could you check to see if you aren't able to stay in the zometa arm if you could cross over to the clodronate arm? |
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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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EileenF
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Posted: Feb 12 2010 at 8:35pm |
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Thanks Donna, I will ask my oncologist and see what she says
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7/09:IDC,stg 3,Grade3, pos lymph;chemo ACT;12/09 lumpect n lymp disect;1/10 bilat masect/tis exp; rad cmpltd 4/10; 11/10 stg 4 lungs chest axil mets & parp trial;3/11 IBC diag;
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