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Bisphosphonates Clinical Trial - any info

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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: Dec 10 2010 at 7:35pm
FYI.  I had to leave this clinical trial because of my recurrence and now participating in the Parpi trial.  Part of the trial requirements are that at the end of the trial you have a bone scan.  I have to take a pill (contrasting) then go back in 3 hours for the scan.  I believe the scan is covered by the study.
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 Morgan513 Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2010 at 8:26pm
Hi Donna--
I've been lurking and following along all the posts these days.  I'm so sad that you have to deal with a recurrence and chemo again.  It just doesn't seem fair.

Well, I had promised that I would post once I had a chance to talk to my onco face-to-face.  Yesterday was my appointment and of course, I followed-up with him about my Ibandronate issues.  He basically said that while he knows that I am doing the study to help other breast cancer patients (truthfully, not really, I am quite selfish as a TriNeg sister and wanted to do more to help myself), that I can stop at anytime.  He said that they do not know whether 2 years or 3 years or however many years will make a difference.  He was not especially encouraging about staying on the trial.  The appointment was disappointment on many levels but with regard to the bisphosphonates, he thinks that I've already derived most of the benefit so if I want to stop I should or can.  

So, I am going to start to look for a new onco team for my follow-up care.  Too many questions and too many disappointing responses.

Oh, btw, I finally found out that 28 days is how many days I can skip taking the Ibandronate before I will be removed from the trial.  When I told them that I read through all of the information they provided about the trial and couldn't find the answer to that question, the trials nurse said that they do not give out all of the information and that as a matter of fact, the information is too much for the trials nurse to digest.  Hmmmm....does this make me feel better???  I don't think so!

Now this study about Zometa comes out and gives me more fuel to leave the trial.  So many decisions.

Lorrie
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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2010 at 10:54pm
Lorrie,

I think you're making a wise decision.  I'd be very upset if I got that kind of a response to my questions regarding a trial that you were committed to and hoped would help.  We  need to have an open relationship with our medical team where we feel that our questions are listened to and we get acceptable responses.

I wasn't too upset about stopping the Clodronate.  Too many gastro issues.  One of the end of study questions was if all drugs were equal, would you prefer the IV or pill form.  Of course when I answered the question at the beginning of the study I said pill form.  I thought, who'd want an IV if you could avoid it and pop a pill instead.  Only thing was I didn't realize you had to take them on an empty stomach in the morning, stay upright for an hour, drink a full glass of water and wait.  I had to change my morning schedule to work around this restriction and inconvenience.  Hard to to do when you're rushing to get ready for work!  So at the end of the study, I changed my answer and said IV instead.

If you leave the trial, will you followup with the bone scan? 

Donna
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 dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2010 at 11:06pm
Lorrie, have you tried taking a half dose to see whether lower dosage would eliminate the symptoms.  It's not trial-kosher, but you could give it a try and see what happens.   (these trials tend to prescribe really high dosages because they want to maximize the signal....less could very well be more)
d
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 15 2010 at 8:58pm

ZOMETA:  Zoledronic Acid Sinks as Breast Cancer Therapy in AZURE Trial

Elsevier Global Medical News. 2010 Dec 10, K Wachter

SAN ANTONIO (EGMN) – In sharp contrast with previous findings, zoledronic acid failed to improve disease-free survival when added to adjuvant chemotherapy for women with stage II/III breast cancer in a highly anticipated phase III trial.

“In terms of primary analysis and primary end point, this is a negative trial,” Dr. Robert Coleman said during a press briefing on Dec. 8 at the annual San Antonio Breast Cancer Symposium. “It is highly unlikely that this conclusion will change with further follow-up.”


http://www.oncologystat.com/news/Zoledronic_Acid_Sinks_as_Breast_Cancer_Therapy_in_AZURE_Trial.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)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jun 10 2011 at 12:09pm

Higher vitamin D levels improve osteoporosis drug response

The Endocrine Society's 93rd Annual Meeting was the site of a presentation on June 6, 2011 of the finding of Richard Bockman, PhD and his associates at Hospital for Special Surgery of a better response to treatment with bisphosphonate drugs among women whose vitamin D levels were higher than the range of 20 to 30 nanograms per milliliter considered adequate by the Institute of Medicine (IOM).

The current study included 160 women with osteoporosis who had been using alendronate, residronate, ibandronate or zolendronate for 18 months or more and who had received two or more bone mineral density scans separated by 18 months to 5 years. Eighty-nine of the participants were classified as responders to bisphosphonates, and 71 were nonresponders, which included 42 women with low bone mineral density, 17 who experienced a fracture, and 12 having a persistently low T-score. "The way the data are expressed for a bone density is how many standard deviations are you away from the normal," Dr Bockman explained. "One standard deviation from the normal is a T score of one. Two standard deviations is a T score of two. Below the normal, it is a minus two and above the normal is a plus two. If your bone density is more than 2.5 standard deviations below the normal, that defines a low bone mass that is considered to be osteoporosis."

The researchers found that bisphosphonate responders were likelier than nonresponders to have a 25-hydroxyvitamin D level of 33 nanograms per milliliter or higher. Eighty-three percent of those whose vitamin D levels were lowest at less than 20 nanograms per milliliters were nonresponders to bisphosphonates, compared to 24.6 percent of those whose levels were highest at 40 nanograms per milliliter or more. "You are seven times more likely to respond to bisphosphonates if your 25-hydroxyvitamin D level is 33 nanograms/milliliter and above," stated Dr Bockman, who is a professor of medicine at Weill Cornell Medical College. "If you want to see a particular outcome from this treatment, then maybe 20 to 30 is not appropriate. When you see a seven times greater effect, that is pretty impressive."

http://www.lef.org/newsletter/2011/0610_Higher-Vitamin-D-Levels-Improve-Osteoporosis-Drug-Response.htm?source=eNewsLetter2011Wk23-2&key=Article&l=0#article



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 mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Jun 10 2011 at 7:15pm
When I posted this the first time it was pretty impressive, but now a couple of weeks later re reading I'm even more impressed, glad you brought it up again!
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jun 10 2011 at 8:08pm
Mainy,

I agree and thought I'd post it under this thread too.  Pretty impressive results.

Donna
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 08 2011 at 9:31pm

Clodronate Offered Modest Benefit for Breast Cancer Patients

Elsevier Global Medical News. 2011 Dec 7, K Wachter

San Antonio (EGMN) - While treatment with the clodronate does not appear to affect disease-free survival among women with stages I-III breast cancer, the drug does appear to improve certain outcomes for women aged 50 years and older, according to the results of a phase III trial of more than 3,000 patients.

Disease-free survival (DFS) did not differ between women treated with clodronate and those given placebo (hazard ratio, 0.91; P = .27). However, women at least 50 years of age saw benefits in secondary protocol predefined end points, Dr. Alexander H.G. Paterson said at the San Antonio Breast Cancer Symposium.

"This is an easy treatment and it's oral. It seems to have an effect in older women and low toxicity. We've now got four trials [pointing in] the same direction ... that is of a benefit in older patients," said Dr. Paterson, a professor in the departments of medicine and oncology at the University of Calgary in Canada.

In the double-blind, phase III National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 clinical trial, patients with stage I-III breast cancer were randomized to receive oral clodronate 1,600 mg daily for 3 years or placebo, given alone or in addition to adjuvant chemotherapy or hormone therapy. Patients also underwent surgery (lumpectomies or mastectomies) and received radiation therapy and chemotherapy or hormonal therapy.

The groups were stratified by age (younger than 50 years or at least 50 years), number of positive nodes and estrogen receptor/progesterone receptor (ER/PR) status. The primary end point was disease-free survival, which was defined to include all recurrences, deaths, and second primary cancers. Secondary end points are the incidence of skeletal metastases, overall survival, recurrence-free interval, bone metastasis-free interval, and nonbone metastasis-free interval.

The researchers reported on 3,311 patients (1,656 on placebo and 1,655 on clodronate) with a median of 8 years in the study. Of note, almost two-thirds of patients (64%) were at least 50 years old at the time of enrollment. Three-quarters had pathologically-negative axillary nodes and almost a quarter (22%) had ER-negative or PR-negative breast cancer.

"Compliance was an issue. The drop in compliance really occurred in the first 6 months, when patients were also receiving intravenous chemotherapy," said Dr. Paterson. A total of 40% of patients did not complete 3 years of study therapy.

Patients on clodronate had a slightly lower rate of treatment failure at distant sites (5.4% vs. 6.6%). The researchers suspect that the disease-free survival benefit was attenuated due to the equivalent event rates for second primary cancers, contralateral cancers and local/regional relapses.

Overall toxicity was low and comparable for the two groups. There was one case of osteonecrosis of the jaw in the clodronate group.

However, clodronate showed benefit regarding distant metastases in all protocol predefined secondary end points. Hazard reductions ranged from 15% for overall survival to 26% for nonbone metastasis-free interval.

Dr. Paterson noted that secondary protocol predefined end point reductions were even greater among women at least 50 years of age. For these women, there was a 24% reduction in breast cancer recurrence-free interval (P = .05), a 39% reduction in bone metastasis-free interval (P = .024), and a 37% reduction in nonbone metastasis-free interval (P = .015). In addition, women 50 years and older had a 20% reduction in overall survival, though this was not statistically significant (P = 0.1).

"Similar beneficial results in older postmenopausal women are seen in other studies involving bisphosphonates," he said.

Bisphosponates are thought to inhibit the growth of bone metastases by inhibiting osteoclast function and subsequent bone turnover. However, the role of bisphosphonates in preventing or delaying the development of bone (or other) metastases in patients with early breast cancer remains unclear.

The trial received support from the National Cancer Institute and Bayer Schering Pharma Oy. Dr. Paterson disclosed that he is a consultant for GlaxoSmithKline, Amgen, Roche Diagnostics, and Nicomed.

http://www.oncologystat.com/news/Clodronate_Offered_Modest_Benefit_for_Breast_Cancer_Patients_US.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)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 09 2011 at 9:29am

Clodronate Appeared Safe, Modestly Affected Breast Cancer Disease Events

A recently presented study revealed that the bisphosphonate clodronate had a low incidence of adverse events and toxicity among patients with breast cancer and may modestly reduce the incidence of distant metastases in postmenopausal women.

The results of B-34, a prospective, randomized, double-blind, phase 3 clinical trial, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 6-10, 2011, are similar to those of trials on other bisphosphonates in this group of patients, according to Alexander H.G. Paterson, M.D., professor in the departments of medicine and oncology at the University of Calgary in Canada.

He and his colleagues enrolled 3,323 patients with stage I, II or III breast cancer between Jan. 22, 2001, and March 31, 2004. Paterson presented data on the 3,311 patients (99.6 percent) with follow-up information. Slightly more than 75 percent of the patients had pathologically negative axillary nodes, 64 percent were 50 years or older at entry and 22 percent had estrogen receptor (ER)-negative or progesterone receptor (PgR)-negative breast cancer.

Researchers randomly assigned patients to receive three years of clodronate or an oral placebo three times a day. In addition, the patients also underwent surgery (lumpectomies or mastectomies) and received radiation therapy and chemotherapy or hormonal therapy. Median follow-up for patients who were still alive was 7.6 years.

Five hundred ninety-eight patients experienced disease events, defined as anycancer (either recurrent breast cancer or a new primary) or death (cancer related or otherwise): 286 in the clodronate group and 312 in the placebo group. The relative reduction of events in the clodronate group was about 9 percent compared with the placebo group.

"This reduction was smaller than had been hoped for and was not statistically significant," Paterson said.

Researchers observed a 16 percent relative reduction in mortality in the clodronate group. They also observed relative reductions of 23 percent and 26 percent in the clodronate group for the occurrence of skeletal and nonskeletal metastases, respectively.

"Although clodronate appeared more favorable for all endpoints, only the comparisons of the distant metastasis-free interval and nonskeletal metastasis-free interval were statistically significant and favorable for the clodronate patients," Paterson said.

Results also demonstrated that clodronate might perform better for patients aged 50 years or older when diagnosed with breast cancer and for women with ER/PgR-positive nodes. Clodronate was generally tolerable, and the toxicities observed were mainly due to concomitant systemic chemotherapy, according to the researchers. This was the largest study to assess clodronate in a placebo-controlled trial, Paterson said.

"At this point, clinical indications are not absolute, but a tolerable agent that has a known beneficial effect on osteopenia with a small reduction in distant disease recurrence may be of interest to some patients and clinicians," he said. "The current trials of targeted RANK-ligand inhibitors against placebo are of great interest." 
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 09 2011 at 8:46pm

Oral Bisphosphonate Did Not Improve Prognosis For Patients With Breast Cancer

Results from a German study demonstrated no improvement in disease-free survival among patients with breast cancer who were treated with dose-dense chemotherapy and the bisphosphonate ibandronate.

Volker Möbus, Ph.D., head of the department of obstetrics and gynecology at Klinikum Frankfurt Höchst GmbH in Frankfurt, presented the results from the German Adjuvant Intergroup Node Positive (GAIN) Study, at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 6-10, 2011.

Möbus and his colleagues randomly assigned 3,023 patients with breast cancer to two different chemotherapy regimens and then further assigned them to 50 milligrams of oral ibandronate or observation. After a median follow-up of 38.7 months, "we found no significant difference between groups in the primary endpoint" of disease-free survival, Möbus said.

He described these results as "disappointing" compared with other studies. In the Adjuvant Treatment with Zoledronic Acid in Stage II/III Breast Cancer (AZURE) trial, for example, Möbus said that the subgroup of postmenopausal patients showed an improvement in recurrence-free and overall survival.

"So far, clinical trials of adjuvant bisphosphonates in early breast cancer have shown variable results, independent from their application (oral compared with intravenous)," Möbus said.

More recently, two trials the Austrian Breast & Colorectal Study Group (ABCSG-12) and the Zometa-Femara Adjuvant Synergy Trial (ZO-FAST) have shown significant benefit in patients with hormone receptor-positive breast cancer who were postmenopausal and received an endocrine treatment only.

Möbus said that in the AZURE trial, 95 percent of patients received chemotherapy and only postmenopausal patients showed an improvement in the zoledronic acid group. "In our [GAIN] trial, all patients received dose-dense chemotherapy, and unfortunately, we could not show a benefit in any subgroup," he said. "We speculate that the high efficacy of dose-dense chemotherapy erases the potential effect of bisphosphonates, which is shown in patients with endocrine treatment only." 
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: Jan 28 2012 at 1:03am

Study pinpoints genetic variation that raises a risk linked to bisphosphonates


Researchers at the Columbia University College of Dental Medicine have identified a genetic variation that raises the risk of developing serious necrotic jaw bone lesions in patients who take bisphosphonates, a common class of osteoclastic inhibitors. The discovery paves the way for a genetic screening test to determine who can safely take these drugs. The study appears in the online version of the journal The Oncologist.

Oral bisphosphonates are currently taken by some 3 million women in the United States for the prevention or treatment of osteoporosis. In addition, intravenous bisphosphonates are given to thousands of cancer patients each year to control the spread of bone cancer and prevent excess calcium (hypercalcemia) from accumulating in the blood. Bisphosphonates work by binding to calcium in the bone and inhibiting osteoclasts, bone cells that break down the bone’s mineral structure.

“These drugs have been widely used for years and are generally considered safe and effective,” said study leader Athanasios I. Zavras, DMD, MS, DMSc, associate professor of Dentistry and Epidemiology and Director of the Division of Oral Epidemiology & Biostatistics at the Columbia University College of Dental Medicine. “But the popular literature and blogs are filled with stories of patients on prolonged bisphosphonate therapy who were trying to control osteoporosis or hypercalcemia only to develop osteonecrosis of the jaw.”

Osteonecrosis of the jaw, or ONJ, often leads to painful and hard-to-treat bone lesions, which can eventually lead to loss of the entire jaw. Among people taking bisphosphonates, ONJ tends to occur in those with dental disease or those who undergo invasive dental procedures.

There are no reliable figures on the incidence of ONJ in patients taking oral bisphosphonates. Estimates range from 1 in 1,000 to 1 in 100,000 patients for each year of exposure to the medication, according to the American College of Rheumatology. ONJ is more common among cancer patients taking the intravenous form of the drug, affecting about 5 to 10 percent of these individuals, noted Dr. Zavras.

Studies have suggested that genetic factors play a major role in predisposing patients to ONJ. Delving deeper into this question, Dr. Zavras and his colleagues performed genome-wide analyses of 30 patients who were taking bisphosphonates and had developed ONJ and compared them with several bisphosphonate users who were disease free.

The researchers found that patients who had a small variation in the RBMS3 gene were 5.8 times more likely to develop ONJ than those without the variation. The study also identified small variations in two other genes, IGFBP7 and ABCC4, that may contribute to ONJ risk.

“Our ultimate goal is to develop a pharmacogenetic test that personalizes risk assessment for ONJ, a test that you could give to people before they start to use bisphosphonates,” said Dr. Zavras. “Those who are positive for this genetic variation would select some other treatment, while those who are negative could take these medications with little fear of developing ONJ.”

http://www.breakthroughdigest.com/medical-news/study-pinpoints-genetic-variation-that-raises-a-risk-linked-to-bisphosphonates/

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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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