Phase II Bisphonates Trial-Should I participate?

[Karen in AK]

I have been asked to participate in the Phase II Trial of Bisposphonates as Adjuvant Therapy for Primary Breast Cancer and am seriously considering doing so.

I am interested in hearing from anyone else who is participating, those who decided not to, and anyone taking Bisphonsphonates (Boniva, Zumata) as part of their treatment.

I would really appreciate any advice from this group. There is such an amazing amount of collective wisdom here.

Thanks!
Karen in Anchorage, Alaska

About me:
Premenopausal (48 yrs old)
Dx: 2/21/07
Lumpectomy:3/5/07
Node negative (2 removed)
Stage I(a), Tumor size: 1.6 cm
Grade 3
ER-, PR-, HER2 +
Chemo: 6 cycles Taxotere, Carboplatin, Herceptin (started 4/6/07), then Herceptin to complete 1 yr
Will have radiation following chemo cycle

[AlaskaAngel]

Hi Karen in AK,

I am not a participant in any bisphosponate trial but just am wondering, you didn't mention whether you have results from any bone density scan indicating whether you are osteoporotic or osteopenic?

Does that clinical trial have an NCT number?

Thanks,

AlaskaAngel

[Karen in AK]

Thanks for your response, A.A.

No, I'm not osteoporotic or osteopenic that I know of. I haven't had a bone density scan since I had a baseline one done years ago for a baseline, long before I was diagnosed.

The study is to see whether adjuvant use of bisphosponates decreases rate of breast cancer metasticizing to bones and if so, which of three bisphosponates works best.

It is Protocol No. S0307 WIRB Protocaol #20060126
Sponsored by the National Cancer Institute.

I will be one of thousands of participants nationwide.

[AlaskaAngel]

I am hoping that you get some responses from others who are doing this trial or are considering it. In the meantime I will mention questions I have about it.

The incidence of osteonecrosis of the jaw in those taking bisphosphonates is less than 8% in studies so far, but the study involves the use of IV bisphosphonates rather than oral I think? The dose IV is massively greater than the oral dose and is of more recent use than the older oral bisphosphonates, so I don't know that the new trial really recognizes that the percentage of necrosis risk from studies so far may not be the same at all. So that would be one thing to ask about. One thing that seems clear from the studies that have been done so far is that the longer the use of a bisphosphonate or the bigger the dose, the more cases of osteonecrosis of the jaw that there are.

Part of the question I have about this trial is based on the fact that bisphosphonates are permanent in the body. I would guess that every person entering the study is advised to have any need for extractions or root canals done prior to entering the study since those seem to be triggers for the development of osteonecrosis. But the study is being done with NED people and if somewhere down the road during the study you need extraction or a root canal, stopping the bisphosphonate and then having the procedure doesn't mean that the accumulated bisphosphonate won't cause osteonecrosis. So... it is a very different thing to be taking IV bisphosphonates for an established need, such as significant osteopenia/osteoporosis or known mets versus taking such drugs as someone who has good bones and is NED.

Then too (as I understand it) less than 50% of those who ever do have mets would even ever have bony mets.

I probably just need to understand better why the people behind this trial are willing to expose the thousands of early stage NED women being recruited for it to what seems to me to be such relatively high risk.

Is it true 2 of the major researchers behind the trial receive grants from the pharmaceutical companies as part of their research? That probably doesn't mean much, though, if most serious researchers nowadays have to depend on some support from pharmaceutical companies.

From what I saw about this trial is that it is a Phase III trial, not phase II?

AlaskaAngel

[AlaskaAngel]

For anyone considering this trial, here is a link that talks about a test that can be done before doing a bisphosphonate to help determine risk:



http://medicalnewstoday.com/medicalnews.php?newsid=75307


AlaskaAngel

[suzan w]

Thanks, Lois, for this link, I just printed it to take next week when I have my DEXA (bone-density) scan and meet with the bone-doc! I already have severe osteoporosis (before bc dx) and have been on biophosphonates for years (oral). Now, after chemo, and on Arimidex for 5 years-all lead to MORE bone loss-I am really worried about my bones. I have heard about osteonecrosis but really do not know much about it. Time to learn is now...before anything else goes wrong!!! Hope you are well and enjoying your Alaska summer!!! Any Seattle trips in your near future??? xox Suzan

[AlaskaAngel]

Hi Suzan! I stumbled on that particular discussion and am delighted to share it. I haven't been prescribed a bisphosphonate myself but do not grasp why the trial is not just being done with patients who have a defined need for it to begin with since it is an adjuvant group. At least the test might be one way to help one decide what one's options and risks are.

We are doing well here too, and very much look forward to visiting with you in Seattle again late this fall so I'm slaving and saving up for that!

XOX

Lois