Is TDM-1 a Miracle Drug for Advanced Breast Cancer?


Last updated: December 20, 2009
Smack in the middle
Image by ogimogi used under the creative commons attribution license.

Breast cancer that's HER2-positive can be particularly aggressive, and HER2-positive breast cancer tends to strike women at younger ages and be diagnosed at later stages, making for some sad stories. This is the type of cancer I've been helping a close friend go through treatment for, so I know just how scary the diagnosis can be.

Happily, the targeted therapy Herceptin has made treatment for the approximately 30 percent of patients whose cancer is HER2-positive much more effective than in years past. But there are women for whom Herceptin -- along with a whole host of other treatment regimens -- either doesn't work or stops working. These tend to be tough cases, and patients run out of options.

But this week there was big news for HER2-positive women: a dramatic announcement about T-DM1, an experimental drug that's been in clinical trials since January. Known colloquially as "super Herceptin" by the women taking it, T-DMI is an unusual joint project between two companies, Genentech, which makes the targeted antibody trastuzumab, (Herceptin), and ImmunoGen, which contributed it's cancer-killing agent DM1.

Oncologists don't like the term "miracle drug," and try not to use it -- but the word miracle was in fact used when researchers presented results of a Phase II trial of T-DM1 at the Breast Cancer Symposium in San Antonio, Texas, last Tuesday.

Oncologists seem certain that T-DM1 (hopefully it will get a better name!) will now be fast-tracked by the FDA, and the rapid expansion and loosening of the trials suggests that nearly everyone Cancer is united in wanting to get this drug out to the women who need it as quickly as possible.

What it is: T-DM1 is a 2-in-1 "Trojan Horse" therapy in which Herceptin zeroes in on the cancer cells and delivers a chemotherapy agent that stops cancer cell division.

Who it's for: Women with Stage 3 or Stage 4 (metastatic) breast cancer that's HER2-positive and resistant to previous treatment methods. The women in the Phase II trials had undergone an average of seven previous drug regimens, including Herceptin.

In other words, T-DM1 is for those who truly need a miracle; and they may finally get one.

The results: Almost half the women in the trials (45 percent) had a positive response, which was defined essentially as a halt to tumor growth. In other words, the drug stopped rapidly progressing cancer from progressing. And in 33 percent of the patients, their tumors shrank. This is in a population that had run out of options and whose tumors had not responded to previous drugs.

As you can imagine, for women who are running out of time and options, their families, friends, and loved ones, this is big news, and -- as a result -- the [Breast Cancer message boards] (http://community.breastcancer.org/forum/8/topic/728426?page=1) started lighting up as soon as word got out.

How to get TDM-1: To get this still-experimental drug, you have to enroll in a clinical trial, though I have heard that some doctors are prescribing it under the rule known as "compassionate use", which allows a seriously ill patient to use a new, unapproved drug when no other treatment is available.

To find an open trial near you, read through this list of recruiting trials maintained by Clinicaltrials.gov, the government's clinical trials database.

There are many different T-DM1 trials ongoing, with differing criteria for admittance, so to stay current and get a comprehensive sense of what's available, you should also do your own search on www.clinicaltrials.gov.

To end on a positive note, and to give you a sense of how exciting these results have been, researchers have created an "extension" study for T-DM1 that essentially allows cancer patients who've been in the trials to continue on the drug indefinitely.

Usually a trial continues for a set period of time, then is terminated so the researchers can process and study the results. But to make sure no one gets kicked off T-DM1 they created this extension trial "by invitation only" which just means your doctor recommends that you stay on the drug.

While just shy of half the women who tried T-DM1 got results, there are a number of "miracle" stories, too: women who were given six months or less to live who've now been on T-DM1 for 10 months or more (most of the trials started in January) and are celebrating positive scan results.

So go, you brave T-DM1 gals; I'm thrilled for you and the families who love and need you, and excited to spread the word about something that's giving metastatic breast cancer patients hope for the future.

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10 Comments So Far. Add Your Wisdom.

26 days ago

I am being offered to participate in the TMD1 trial through MDA…how do they monitor it's effectiveness? I am HER2+ with IDC, stage 1…deciding whether to do the trial or stay with the standard treatment or do the trial and have standard treatment as a back up.


Anonymous said about 2 years ago

Is this treatment only effective so far for breast cancer? Has it been tried for others?


over 2 years ago

I want to know how I can get this medication I am in the 4th stage and take herceptin every three weeks my doctor at Md Anderson say the cancer has now spreaded to the walls of my lungs I want to try this mircale drug


over 3 years ago

I too have HER2+ beast cancer that met. to my liver, for 4 years. I went through all of the treatments, carbo, taxotere,taxol, herceptin and others that I can not remember. Cyber knife surgery with radiation, liver surgeries, I have been through everything. I am now taking the T-DM1 drug, I have to travel to get it. The stress this puts on a stage 4 patient and their families, to me is very un-necessary. If you qualify, you should be able to get the drug through your doctor, at home, where you are comfortable, your doctor can follow guidelines and report any issues. It really saddeneds me to have to put my family through this in the first place, now this added stress. I wish drug companies would really reconsider how trials are run. Without us, they would not have any trials. This drug has been in trails for 13yrs. I saw the news reel with Phil and Lorraine from Boston, she is 100% correct. It is very stressful. I am very happy that she has grandchildren and is here to enjoy and love them. We are waiting to meet our first grandchild in June 2011. Hopefully with T-DM1, I will meet mine.


almost 4 years ago

I'm so glad about your wife! My best wishes to you! I'm a candidate for a clinical trial with TDM1 and your comment gave me strength, faith and confidence! I ask god for a miracle and I think I will get it!


almost 4 years ago

My mom is ER+/HER2 negative/neu (HER-2/neu) . . . would this work for her at stage 2, 3 or 4??? It sounds like we want this drug over the Herceptin they are wanting to try. I want to implement the best possible treatment and after discussing this with my mom, we are more than likely gonna ask our oncologist about this "super Herceptin" of sorts. We are ABOUT to start a trial w/ Herceptin and about 4 other meds... so if we can do something different... I am just curious about those with NEGATIVE HER2 where estrogen is believed to be the majority of the cause. Thank you SOO MUCH for posting this information.


almost 4 years ago

hiiii.... im dr.yaser from saudia arabia... my mother has acute meyloid leukemia on palliative chemotherapy.. is it possible to use this new medicine on my mother case? and if it is.... how can i get it... thank you.....


Anonymous said almost 4 years ago

My wife has breast cancer that's HER2-positive. Starting in her breast it came back in her liver (3 spots) and her spine (2 spots) and her hip bone. Then in April 2 tumors were found in her brain. After 2 years of several kinds of chemo and radiation her poor body was so worn down she could walk to the mailbox and back and had to take a nap. Her oncologist was going to keep her on the chemo drugs until she just couldn't go anymore. We decided to get a second opinion and the new oncologist recommended that she begin a treatment of TDM1. Last week we got the last of all the test and there is no sign of cancer in her whole body. First, I praise the Lord Jesus Christ and secondly I thank God for TDM1 and pray daily that the drug will get okay-ed by the FDA soon. It is a miracle drug. alight


about 4 years ago

so glad to hear the good news..now my mom had a conservation surgery and recieved chemo and radio-therapy, then 3 years later she got another tumor in the same breast which was HER2+ and had a mastectomy then chemo + herceptin...her scans seem to be good and thank GOD clear... i'm asking now is there anything we could do 2 stop the recurrences? any medication or regime she should follow?? also how do we reverse the side-effects of taxotere such as neuropathy? thanks!


about 4 years ago

io sono una her 2 + metastatico refrattaria alla chemio tch (taxotere, carboplatino, herceptin) attualmente in cura con herceptin e vinorelbina. ho metastasi nei vasi linfatici del torace, puo' essere efficace per me il t-dm1? ed e' possibile effettuarlo in italia? grazie


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