Does T-M1 trial require prior chemo?

[Rich66]

My mom only had radiation and arimidex after surgery. Trying to understand if she has to work through other treatments before being eligible for trials.

[lilyecuadorian]

Rich I think you need to be resistent to herceptin ,

[chrisy]

Rich, the trial I'm in requires prior chemo and herceptin. Most early drug trials do require some prior therapy - which actually makes sense, as you should go with the "proven" approach first.

[Rich66]

What woudl be considered standard or proven for a chemo naive mets patient?

[runtolive]

http://www.clinicaltrials.gov/ct2/sh...erm=dm1&rank=5

i dont think your mom would qualify for any of the tras-dm1 trials. it is for metastatic patients. or patients who have recurrent tumors beyond the breast.

run

[Rich66]

Mom has mets to the liver

[chrisy]

Rich,
Your mom would probably qualify for the trial that runtolive posted in terms of the stage of disease and that she has not had prior chemo for metastatic disease. There is an exclusion for some types of chronic conditions including pulmonary, which might be an issue due to your mom's emphysema. You'd have to check on this.

Your other question, what would be 'standard or proven' - your mom's case is similar to mine, I had no adjuvant chemo so my first chemo experience was in the metastatic setting. Taxol+herceptin would be a 'proven' therapy (in fact, it is the other arm of the DM1 study that runtolive posted). I had this plus carboplatin, but I had extensive liver mets and they wanted to hit it hard.

Truth is, tho, even if your mom qualified for the trial, she might be in the taxol/herceptin arm anyway.

The taxanes (taxol and taxotere) are highly synergistic with herceptin, so that would be a good bet. I don't know how extensive her liver mets are, but if there is a significant amount of disease there, you want to get it under control.

Your mom and her doctor will have a better idea of how well she is able to tolerate treatment given her age and other health issues, but I can tell you that many women of her age do very well with chemo.

Rich, I'm so very impressed with the amount of research you've done on this - your mom is a very lucky woman to have you advocating on her behalf.

[chrisy]

Rich,

I also wanted to say, since your mom is "chemo naive", any type of chemo may deliver a really good wallop. She may be able to gain control over the liver mets quickly and then maintain on herceptin for a long time. There is good reason for hope.

[Rich66]

I just got off the phone with genentech. I didn't realize there are different versions of the trial with different exclusion criteria. Unfortunately I could not get any indication when the not recruiting trials would begin. She said "probably soon". Um hmm.

http://www.clinicaltrials.gov/ct2/re...mab-MCC-DM1%22

1
Not yet recruiting
A Study of of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Condition:
Metastatic Breast Cancer Intervention:
Drug: trastuzumab-MCC-DM1
2
Recruiting
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Condition:
Metastatic Breast Cancer Intervention:
Drug: trastuzumab-MCC-DM1
3
Not yet recruiting
A Study of the Efficacy and Safety of Trastuzumab-Mcc-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-Positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease Condition:
Metastatic Breast Cancer Interventions:
Drug: trastuzumab-MCC-DM1; Drug: trastuzumab; Drug: docetaxel

[runtolive]

rich .. where does your mom live.. city and state.

[Rich66]

Lake Mills, WI
30 minutes from Madison, WI about an hour from Milwaukee, WI, about 2.5 hrs from Chicago

[runtolive]

you are in that devils triangle.. no one center in your immediate area...

the closest sites listed on

http://www.clinicaltrials.gov/ct2/sh...ow_locs=Y#locn

are chicago and minneapolis

i would call genentech again and ask them if there will be any sites in the wisconsin area.

[chrisy]

Definitely call on the locations. The list on the trial link is not accurate. I've been on that trial in California since February...and it does not show ANY locations in California. However, this trial DOES require 1 prior chemotherapy and Her2 directed therapy so I don't think mom would qualify.