AC + T / herceptin trial

[louise a.]

is anyone doing this trial? if so, how's it going? what tests did you have to have before you began?

[Merridith]

I am probably in this trial. (I say probably because you don't give the name of the trial). It is an an adjuvant trial of herceptin after a course of A/C + Taxol.

I am on the observation arm of a 3-arm trial. The other two arms receive herceptin.

All of the arms are treated identically.

To go on the trial, you had to have a sample of your breast tissue sent to Germany where they confirm that you are HER2 and then store a sample.

You must have a MUGA test to confirm that your heart is in good order before commencing the trial. These MUGA tests are repeated every 3 months. You must also meet with a clinical trial nurse every 3 months where they ask you standardized health questions and record baseline vitals.

The frequency of these tests reduce after 12 months in the trial, but you continue to be followed for 10 years.

That's it.

Regards,
Merridith

[Merridith]

Hi Louise a:

I have just read your question that you posted further down the board, wondering about how you can join this trial. I thought that I would answer you here, because you are more likely to read it here.

Unfortunately the trial has received all the volunteers that it needs. I was one of the last ones to be accepted before they closed the gates. As far as I know, there isn't anything else available for adjuvant patients at this time.

If you live in the USA, I understand from reading these boards that you can sometimes with great effort find an oncologist to give you herceptin off-protocol. But unless you have good health care coverage, you will need a very good bank account. I believe that it costs $50,000 @ year to buy.

Regards,
Merridith

[SusanAnne]

Hi Louise. I have finished treatment in a trial like you describe. I was in the arm which received 4x AC, then 12x weekly T + herceptin, then 40x weekly herceptin. The other two arms were 1) 4x AC then 12x T, then 52x herceptin and 2) 4x AC then 12x T and no herceptin. Before beginning I had to have a MUGA scan, Cat scan of chest, abdominal and pelvic areas and a bone scan to rule out mets. A pregnancy test is also required. As far as I know, the trial is still open. I'm in NY. So far things have gone good for me. I was stage IIIa when diagnosed in 3/03. Hope this helps.

Susan

[louise a.]

thanks susan,
yes this is the trial that sounds like the one i'm trying to get into! glad things went well for you...i'm getting my pelvic exam monday, but didn't know i needed a cat scan too....my cancer center staff don't seem to know much about what tests i need, and this is delaying things...i've already had an echo of chest and a bone scan...

[louise a.]

thanks merridith,
i think the one i want is the one susan is in...as for the cost of the herceptin...WOW...but it'll be free if i do the trial, which is a good thing, as i have no insurance!

[SusanAnne]

Hi Louise,

The echo you had sounds like an echocardiogram, which might take the place of the MUGA. Perhaps the pelvic exam you are getting takes care of the pregnancy test. My CAT scan might have been the requirement of my own doctors, not sure. At my first treatment, I met the nurse from the center running the trial in my area and she took some vials of blood for their research. Have you signed all the paperwork and gotten a copy? Some of the info you are looking for might be in there. Have you gotten a port? I recommend it very highly!!! What stage were you diagnosed at and what are your particulars?

Susan

[*_anne_*]

Hi Louise,

The trial name is the B-31 trial as far as I know. You can get the Herceptin "off-label" for adjuvant tx if your onc appeals to your Insurance company. If not after 3 appeals, Genentech(the maker of Herceptin) will give it to you free. Call them or check out their website. I read it in a pamplet at the onc's office.
Good Luck
Anne

[Rozebud]

I was randomized to the A/C/T/H arm of the BCRIG 006 trial, receiving 4 rounds of A/C (every 3 weeks), 4 rounds of taxotere (every 3 weeks), and 52 weeks of herceptin (weekly for the 1st 12 weeks concurrent with T, then every 3 weeks). I have no idea if the trial is still open, but I say go for it if you can!

I was dx'd in 1/04 with stage IIIC. Will finish herceptin in May 05. So far so good, knock on wood!

[louise a.]

thanks you guys, i have signed the consent form and will begin CALGB phase lll trial wed. mar 9...guess i'll find out then which arm i got...i'm really praying for herceptin!

[SusanAnne]

Hi Louise,

I didn't find out which arm I was put into until my second or third AC treatment. Just don't want you to go and be disappointed when you don't find out. Good luck to you and keep us posted. I'll be thinking of you.

Susan

[Phylicia]

Do you kow if there are any physicians or hospitals in the Washington Dc/Baltimore area who are participating in this trial? How can someone in the DC area find out about the trial. I have a friend who isinterested in participating in a trial that includes herceptin even though she is not metastatic. Please advise.

Thanks, Phylicia

[SusanAnne]

Hi Phylicia,

Go to clinicaltrials.gov and type in herceptin, breast cancer and a bunch of trials will come up. You'd have to read thru them to see if she would qualify (that would depend upon what stage she is, if she had any positive nodes, etc.). If you scroll down on each one it will tell you the centers that are participating in that trial. She should also ask at her oncologist's office. If there is nowhere near her perhaps her oncologist will give her herceptin "off label". Good luck.

Susan