Hi ladies, Iam wondering if any of you ladies can give me any advise? .I know some of you are very knowledgeable on current issues, politics ,ect.The daily mail Sept 17 wrote a report saying that by adding the bone strengthening drug ,zoledronic acid to your current hormone therapy can reduce recurrence by 33%. It costs less than £1000 a year and requires 7 IV infusions over 3 years.I have spoke to the oncologist at my hospital and he has agreed and said that my hospital had also done trails and the results looked very encouraging.Well then i asked if my sister could have it instead of the oral bisphonate that she is currently on (age 37, large grade 3 tumor with lymph node involvement . dexa scan showing some bone loss to spine, hence oral bone strengthening medication ) Well guess what he said NO, not licensed yet,waiting for all results of trails etc!!!. what I would like to know ladies is if any of you ladies are already on IV zoledronic acid without a secondary bone diagnosis, and how long does it take for these drugs to start being used following positive research. I would be willing to pay for the drug but i understand that you can’t do this either ??? ANY help, advise would be much appreciated,
Best wishes to you all
claire x

I would be interested to know this aswell…also will it be offered to patients who are a few years down the line and who are taking Arimitose Inhibitors…is it worth a mention at the docs?

Hi Claire, I was interested in your post, have heard of this trial, copied below, although it mentions chemo not hormonal treatment so not the same trial I guess, thought others may still be interested to read it though so I’ve copied below from the CRUK site. (all the w’s dot cancerhelp dot org dot uk) It would seem as your sister is already having bisphosphonates she’s not eligible for this trial unfortunately and it only covers Sheffield. I have bone mets and am taking Ibandronat/Bondronat tablets, I was told the daily dose can be better than an infusion which has the effects/benefits tail off towards the end of the cycle. Good Luck, I hope you can find out more info…x

A trial to see if zoledronic acid can help chemotherapy work better before surgery for breast cancer (ANZAC)
This trial is to see if using zoledronic acid with chemotherapy will help treat breast cancer.

Zoledronic acid (Zometa or Zoledronate) is a bisphosphonate. Doctors use bisphosphonates to reduce pain and damage that may happen when cancer spreads to the bones. We know from laboratory research that zoledronic acid kills breast cancer cells. Researchers in the laboratory have now found that using zoledronic acid and chemotherapy together may kill more cancer cells.

Many of these results are from looking at cancer cells in a laboratory. Now researchers want to see if adding zoledronic acid to chemotherapy increases the number of cancer cells that die as a result of treatment. This is a pilot study. If researchers see encouraging results, they may go on to a larger trial. The aim of this trial is to see whether adding zoledronic acid to breast cancer chemotherapy helps chemotherapy to work better before surgery.

Starts 30/07/2007
Ends 31/12/2008

Phase 2

Who can enter this trial
You can enter this trial if you

Are a patient being treated in Sheffield
Are a woman with invasive breast cancer
Have breast cancer that is at least 2 centimetres across (stage T2)
Need to have chemotherapy before your surgery
Have had, or will have, a breast tissue sample taken to examine under the microscope (a core biopsy)
Are willing to have another core biopsy before your second cycle of chemotherapy
Have satisfactory blood test results
Are well enough to take part (performance status 0, 1 or 2)
Are willing to use reliable contraception if there is a possibility that you might become pregnant
Are over 18 years old

You cannot enter this trial if you

Have breast cancer that has spread to another part of your body (metastasised), or has come back after treatment (recurred)
Have already had chemotherapy, or radiotherapy to your breast
Have had bisphosphonate treatment in the last year
Are taking tamoxifen or an aromatase inhibitor that will not stop before the trial
Need to take medication to thin your blood (made from warfarin or coumarin)
Are allergic to bisphosphonates
Have had any other cancer in the last 5 years, apart from cancer in your other breast (more than 6 months ago and you did not have chemotherapy) or carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated
Have heart problems that may be made worse by the types of chemotherapy used in the trial
Have problems with your mouth or teeth including infection or a bone condition in your jaw called osteonecrosis
Have had in the past 4 weeks, or are due to have, dental or jaw surgery (minor gum surgery doesn’t count)
Are pregnant or breastfeeding

Thanks ladies, Belinda, There is a piece about the above trial mentioned in the same article.It is being done by professor Coleman at Sheffield and you are right it involves giving zoledronic acid with chemo. at my hospital they have also done a trial in with they gave zoledronic acid a day after the chemo, (or a day before) i seem to remember. the oncologist the said results looked very encouraging. My sister finished chemo 1 year ago, is on arimidex and a dexa scan showed bone loss to an area in her spine ( T-1 ) The oncologist then started her on an oral bone strengthener, I work as a nurse and have checked the price of the tablets which are very expensive. The trail the daily mail talks about is by professor Michael gnant of the medical university of Vienna. 2000 women, aged 44 on average, were given either tamoxifen or anastrozole to prevent recurrence after surgery. half of each group also took zoledronic acid. After 3 yrs, those taking the bone-loss drug had a reduction of 33% in recurrence rates compared with those just taking hormone drugs. There is also something mentioned on the American breast cancer site . org. What I would like to Know is when will this drug be available to all, or can we pay ourselves?
Thanks again ladies
claire x

Hi there, I am having zometa infusions every 6 months after the dexa scan I had done showed that I had bone density loss in the lower back and neck area. I have to say that reading your post about it’s reduction in recurrence is really great to hear. I finished chemo in September '07 and started zometa in June '08 and I’m 28 now. I am also on zoladex injections every three months and tamoxifen. Sorry I can’t help you regarding the availability of the drug and if you can pay for it but thought I would let you know of my situation. Thanks, x

Thanks teacup, Glad you are getting zometa. My sisters oncologist did say he thought that eventually it may become a standard treatment but was reluctant to change my sister to it as he says it has not yet been licensed in a primary breast setting. Can I ask teacup what hospital are you being treated at, are you private? I would love to know if any more ladies are also getting this drug. Got next hospital appointment in December and need as much info as possible !!
thanks again teacup and good luck with the rest of your treatment. I thought my sister was young (36.) she has also had her ovaries out .x

Hi Flo,
Unfortunately, it can take a while for the NHS to adopt a finding announced at a conference. For example, with herceptin against primary breast cancer the results were announced at a conference in May 2005 and published in November 2005. Then NICE set up a review for August 2006 and some NHS hospitals starting supplying it in December or January 2007, but many places didn’t start using it until the middle of that year. A third reduction in recurrence is brilliant, though, so it is definitely worth figuring out how to get it. Technically, trusts don’t have to wait for a NICE recommendation to act, but they are all so cash strapped that few will act without it. NHS oncologists seem reluctant to use a drug before it has been licenced for a particular use (although at least it is licenced for something already, which helps). Licencing for a particular use follows publication (so let’s hope Gnant’s reviewers are fast). The US is very different in that oncologists have the right to use any licenced drug against any type of cancer. As you probably know, the NHS currently looking at this whole issue of patient top ups, so if the situation gets too loopy write your MP.
Best of luck.

I’ve been on Zometa for the past 4 months as Pamidronate stopped working for me and my oncologist just changed me over to it without any problems - roll on the day when all Trusts do the same good practice.

Interestingly Christine about the US - they have great problems recruiting people for clinical trials over there - I was taking part in a teleconference on Wednesday and they said patients are very reluctant to enter themselves into trials whereas in Europe that’s how most of us get to have these drugs yet they said they have the potential to go forward at great speed with some of these new drugs but are held back due to lack of patients’ unwillingness.

I was on the ZICE trial hich is being run nationally as far as I know. That compares results between zaledronic acid and ibondronate but i think only open when bony mets first diagnosed. I have had 96 weeks of zaledronic acid and that meant I’d reached the end of the trial but have stayed on it anyway. Didn’t realise it wasn’t licensed or is it licensed and not recognised by NICE?
There is also the BISMARK trial which looks at biphosphonates and again I believe is still running.
Good luck - this co-payment thing is awful

Claire, I am being treated as a public patient in Ireland (Hopefully it’s ok for me to hop on these forums but we have nothing like this in Ireland). My onc trained in America and is really open to trying new drugs. I know of another lady on these forums who is being treated in the UK who is also getting 6 monthly Zometa infusions for bone density loss. It is interesting that your sister had her ovaries removed. I have been thinking about this. Has she had children already? I haven’t, however my prognosis is poor and I guess I am thinking at the moment that I would do anything to keep the bc at bay. Also, I just wanted to say that your sister is very lucky to have you helping her out like this and I hope she is doing well. x

I asked about this when I read the article in the Daily Mail, as I was diagnosed with severe osteoporosis after my Dexa scan and am taking alendronic acid.

My oncologist said that zolendronic acid can have a nasty side effect affecting the jaw, and he didn’t seem in favour of prescribing it unless it was for secondary bone cancer.


Hi justme, I know a couple of people with the jaw problem, it’s called osteonecrosis of the jaw and it’s usually after prolonged use as in treatment for secondary bone mets…it’s still quite rare (I don’t want to worry anyone, I would change to Zometa if my bones got worse, it’s a good infusion) but it’s not only a zometa problem other bisphosphonates can be troublesome but yes zometa seems to cause more problems. Many of us with mets (I’m one) are living longer thanks to various treatments and I think that’s why there’s more instances of osteonecrosis now. When you have mets you tend to have more frequent infusions, mostly every 3 or 4 weeks. I’ve been on pamidronate and now ibandronate since 2003 and (so far!) have no jaw problems. Anyone on any of the bisphosphonates should now be advised (by their oncologist) to stop taking the infusions or tablets a few weeks before and after any dental work…anyone about to have dental work do tell your dentist/oncologist you’re on bisphosphonates…Best Wishes…x

Im on the Azure trial and have 6 monthly infusions (having worked my way up from 3 weekly) and seem to be doing well so far.I was grade 3 e neg aggressive with lymph node involvement.
I felt I was lucky to get on this trail as I am also on the TanGo trial.I don’t have secondaries so far.

I was given a laminated card to give to my dentist if I was having treatment .This basically states what treatment I am having and what precautions the dentist has to take.

I had a dental emergency a few months ago and had to ask my Trails nurse advice about dental treatment. She found that it was advised that treatment was okay thin only 24 hours of treatment. We (my Onc and I ) queried this but apparently this is right. We both thought it was 3 WEEK!! We don’t know when this advice changed though. And we felt that a longer time between infusions and treatment was more advisable.

I do hope your sister does well on whatever treatment she has.

Thank you ladies for your replies, Well i have been trawling the Internet !! ,and there are many trials going on at the moment looking at the effects of giving biophosphanates in the primary breast cancer setting. They are trying to establish how, and by how much bone strengthening drugs cut the chance of a relapse.
Teacup, you sound like you have a good forward thinking oncologist, perhaps that’s because he is American ! .I wish we could be more pro-active in treating /dealing with disease , but as always, here in the UK we seem to lag behind with starting new drugs and treatment regimes, even with positive trials… SO frustrating.
My sister doesn’t have any children and probably would have liked to have had some ,but her tumor was large and very oestrogen positive (8). The doctors advised her that she could have eggs harvested but should wait at least 5 years before trying for a baby. This would make her 41 , She is also a high risk of recurrence so therefore decided to hit it with everything she could including having her ovaries out.
My sister now works abroad, and as i am a nurse she leaves all the research etc to me LOL . I don’t mind and will do everything in my power to help her, including pushing for new drugs !!
Wynn I am pleased that you are taking part in 2 trails, are you by any chance being treated at Sheffield. My sister was not offered any unfortunately. I am pretty sure that bone strengthening drugs will become a standard treatment .BUT when?
Well thank you all again,
Dippy kate, i have read some of your blogs, you are truly inspirational and i wish you all the very best.
If any more ladies are getting Iv Zoledronic acid with primary breast cancer i would love to hear from you
Claire x

You are a very good sister!

To answer Dippykate’s question, zolendronic acid seems to be licenced for use in secondary cancer patients with bone problems, but that doesn’t mean it is licenced for patients with primary breast cancer. Drugs are licenced in Europe for particular conditions (in contrast in the US drugs are licenced to be marketed for specific conditions). Someone who worked for the NHS once told me that getting a drug that is not licenced for anything is nearly impossible because the oncologist would have a tremendous liability if things went wrong. It is less risky if the drug has a licence for something, but still not usually done.

Zoledronic acid has been licensed for use in post-menopausal women with osteoporosis/bone density probs.
Usual dosage 1 IV infusion annually. Until the licensing comes through for primary cancer it may be a way to get access to it.
My onc has discussed it with me as I have strong family history of osteoporosis on top of my cancer stuff.

thanks Christine and msmolly,
I did not know that zoledronic acid was licensed for post menopausal women with osteoporosis. this may well be a way that many ladies who have had primary treatment for breast cancer with some bone loss to approach there surgeons/oncologists into getting the bone strengthening drug, should they so wish. Msmolly do you know how bad your bones have to be ?. daft Question??.. but my sister should qualify for post menopausal now shouldn’t she? even if she is only 37, she had her ovaries removed 1 year ago ??
ms molly do you mind me asking if you are having this treatment or not ?
Being at the patient receiving end of things has opened my eyes! I have realized that those that SHOUT loudest definitely get more notice taken of them in the hospital setting, and unless you are ‘informed’ and ask, you often don,t get.! So very wrong , i know, but it has certainly been the case where my sisters treatment has been concerned,
So ladies, lets keep feeding each other with any knowledge, helpful tips that we all have.
All the best, claire x

I’d say that if your sister is already prescribed a bisphosphonate then she must have evidence of thining.
If she has had her ovaries out then she will be post menopausal. It happens instantly.
I am still undergoing chemotherapy Claire so I am not going down that path yet. But I am keeping tabs on things and nagging my onc constantly.

I think the problem with zoledronic versus alendronic is the need to administer intravenously - expensive, etc. Zoledronic acid is the drug of choice for elderly women who are particularly badly affected by osteoporosis.
I would say that the one area of concern with zoledronic is jaw necrosis - I suspect this may be a factor which is hampering UK licensing. There has been some evidence of this in the US among long term users. As another caveat I’d also say that the studies were using 6 or 7 doses annually whereas the typical dose for osteoporosis is once a year.

I certainly think that if there is significant osteoporosis risk then it strengthens the case for onc nagging. You have nothing to lose and it keeps the medics on their toes.
Good luck.

Just thought i would update you ladies with the latest news. my sister saw the breast surgeon for her 4 monthly appointment and he has agreed that she can have the zometa iv . GOOD NEWS. I asked for her to have it on the account that she was already on oral bone strengthening tablets. He agreed that research looked promising and said he would arrange it .Fingers crossed ! Hope all you ladies are having good results from your treatments, and equally positive meetings with your doctors. Can I ask if there are any more ladies who are getting this drug in the primary breast cancer setting and if so, how are you getting on with it? Best wishes