Enrolled in T-dm1 Teresa trial
 

In Jan, I became very sick unable to keep food down. In Feb, it was confirmed mets to my stomach.
Best option was to try for Terrsa trial 2/3 get tdm1 1/3 get physicians choice. The trial just started enrolling and not all of the 175 sites are open. I had to wait four weeks to get on the trial during which I ended up hospitalized almost two weeks with complications. This will be my seventh chemo regime.

I got dced from hospital Wed and went to start trial on Thursday. Don't you know I got randomized to non t-dm1 arm. My oncologist is really upset. Said I can't catch a break over last 9 years. It was my best shot. I had seven years stability herceptin, tykerb did nothing.

I was frustrated bc I could of started RX weeks ago if I knew it would of been physicians choice. There is no crossover opportunity so if I progress they will not allow you to have tdm1. I was also told bc trial is brand new there is essentially zero chance of expanded access reopening up.

I didn't qualify for eap before it closed bc I hadn't failed the tykerb then. I lost 30 pounds in two months. Now have pleural effusion.
I did a researcher marketing study when they thought tdm1 was going to be approved in 2010.

I knew there was a chance I would not get drug. 10 years ago I did a study when first dxed trying to get Herceptin but was also randomized to 1/3 that did not get Herceptin. But that was at end of study and they ended up opening it up to everyone.

I feel like the FDA has signed my death certificate.

Even onc running the trial she said its had problems bc of Avastin. Yet Avastin is still available. I have friends on it but I have no chance at getting the drug that could save my life. Help me see my 11 to grow up, graduate 6 grade, start middle school.

I thought I was ok with just getting Gemzar but reading all the success stories of tdm1 makes me so frustrated for myself.

Kelly

Re: Enrolled in T-dm1 Teresa trial
 

Kelly,

I'm sorry for what you've been through. Hopefully T-DM1 will get approved soon.

Below is an abstract about Gemzar. It looks like a good treatment option:

Cancer Chemother Pharmacol. 2012 Feb 17. [Epub ahead of print]
A multicenter phase II trial of docetaxel plus gemcitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer.

Karachaliou N, Kouroussis C, Papakotoulas P, Kalbakis K, Tryfonidis K, Vardakis N, Poppis E, Georgoulias V, Mavroudis D.
Source

Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470, Athens, Greece.

Abstract

OBJECTIVE:

To evaluate the docetaxel-gemcitabine (DG) combination administered every 2 weeks as salvage therapy in anthracycline- and taxane-pretreated patients with metastatic breast cancer (MBC).
PATIENTS AND TREATMENT:

Thirty women with MBC who had disease progression after chemotherapy with anthracyclines, or anthracyclines and taxanes were treated with docetaxel 50 mg/m² and gemcitabine 1,500 mg/m² on days 1 and 14 in cycles of 28 days. All patients had received prior anthracyclines, and fourteen (46.6%) had also received prior taxanes. All patients were evaluable for toxicity and 24 for response to treatment.
RESULTS:

Complete response occurred in four (13.3%) patients and partial response in 10 (33.3%) for an overall response rate of 46.7% (95% CI 28.8-64.5). Seven patients (23.3%) had stable disease and nine (30%) progressive disease. Of the 14 patients previously treated with both anthracyclines and taxanes, seven (50%) responded. The median duration of response was 4.8 months (range 1.9-15.3), the median time to disease progression 6.6 months (range 0.5-16.9) and the median overall survival 16.8 months (range 1.3-53.2). There was no treatment-related toxic death. Neutropenia was the only grade 4 toxicity occurring in three (10%) patients. None of them developed neutropenic fever. Grade 3 thrombocytopenia occurred in two (6.7%) patients. Non-hematological toxicities were manageable.
CONCLUSION:

The DG combination administered biweekly is very well tolerated and effective in anthracycline- and taxane-pretreated patients with MBC. A previous treatment with taxanes does not preclude a good clinical response to this regimen.

Re: Enrolled in T-dm1 Teresa trial
 

Being enrolled in arm of th3resa trial that wasn't your "physician's choice", would your oncologist be willing to work with Genentech and FDA to see if drug, for which approval is expected to be applied based on Emilia's PFS data by mid-year, could be made available for time being as "compassionate use"?

http://www.fda.gov/ForConsumers/ByAu.../ucm176098.htm

Re: Enrolled in T-dm1 Teresa trial
 

I am so sorry. I know this must be very frustrating for you.
We are all keeping our fingers crossed for FDA approval of T DM1.
There is another drug called Petuzamab that Genetech applied to the FDA for approval. A decision is expected by June, 2012. Ask your doctor to check on that one. Genetech's website is www.gene.com Check for press releases from time to time.
You can also go to www.clinicaltrials.gov
and do a search on breast cancer trials in your area. You might just find something else that may be promising.
Ask your doctor if you can use Gemzar with Herceptin. That might give you extra protection.
I know it is hard, but try to stay positive and keep putting one foot in front of the other.
Take good care of yourself.

Re: Enrolled in T-dm1 Teresa trial
 

Cross your fingers for approval on JUNE 8TH. JUNE 8TH. Tweet tweet!
Karen

Re: Enrolled in T-dm1 Teresa trial
 

Hi Kelly, I am so sorry to hear. you have been through a hard time and some bad luck. This lottery is so inhumane and I still have to see what I will be randomised in myself. It is so hard to feel like we are a number/data and that our chance at getting a drug that may work is not as important than their blimmin data, so wrong.

In the meantime I hope that the phycisian's choice turns out to be the right one for you. Indeed Gemzar can work well for some.

Sending you good vives

Re: Enrolled in T-dm1 Teresa trial
 

Hi, Kelly. I'm sorry to hear this news. 10 years fighting mets! Wow! And yet, there are still so many other treatments you haven't tried yet, and more new ones coming down the road. I pray everything works out for you. So what did your oncologist decide to treat you with on this trial? Keep us posted on you.

I live in South Jersey - in Atlantic County. I go to UPenn for treatment.

Re: Enrolled in T-dm1 Teresa trial
 

If it is physician's choice, is the doctor also giving Herceptin with the Gemzar. I would demand the Herceptin witht the Gemzar and not just the Gemzar alone.

Re: Enrolled in T-dm1 Teresa trial
 

Kelly,
I'm so sorry for your latest, frustrating disappointment. I agree with FOB, if I never hear the word "data" again, it will still be two days too soon for me!!!
This whole lottery approach to treatment is so wrong!
Like Karen, I'm hoping, praying, and contacting all my elected representatives about getting TDM1 approved for all of us ASAP!

You've been so strong for so long...hang in there. I'm sending hugs and prayers your way.
Denise

Re: Enrolled in T-dm1 Teresa trial
 

Kelly, I am so sorry. I'm hoping and praying your answers will come soon. Please know prayers are going out for you and your family.

Re: Enrolled in T-dm1 Teresa trial
 

My wife got her best response prior to tdm-1 out of herceptin/gemzar. 18 months of stability. That was early in her fight, but she was Stage IV from the start. The idea is to keep surprising the cancer w/ something new.
If you try another choice, think about compassionate use as the next step, if needed. It will be about a yr until t dm-1 approval, maybe a little less if we keep the pressure on This FDA, and This Pres., in an election yr. Really, when you look at t dm-1 and avastin , His Administration has been a Disaster for Stage IV BC. Sad. And Genetech top execs making abusiness decison to deny comp. use. Shameful. Sooner or later , their actions will get the negative Public PR that they deserve. Someone will be the first , hopefully , to get comp. use. You may have to push your onc to talk w/ Gen. docs. A lot of oncs are reluctant to get into it, they know its crooked. The FDA washes its hands of it, wouldnt even talk to us . Said " Talk to your doc, have them talk w/ Genentech. Then they talk to us . We dont need ( or want ) to talk w/ you. " Un-believable. And they re-write the accelerated approval law, ignoring the people ! That single pt. /comp use system is crooked, will need changing. Too much power w. private business in that equation. They are selling life-saving meds, not computers ! In that area we need an FDA that works for Us !

Re: Enrolled in T-dm1 Teresa trial
 

Praying for you, Shaysmom. Don't give up the fight.

Re: Enrolled in T-dm1 Teresa trial
 

Sorry for not getting back, I had a rough few months and wasnt able to get up to our main computer just online with my phone and couldnt get on here.

The Gemzar is keeping me stable after 4 cycles and two sets of scans. Cancer ran wild while I was off treatmnet for two months so its a challenge to get ahead of it but stability is good!!!

But my oncologist spoke directly to the person running the TERESA trial and they are going to open up crossover, meaning "if" or when the Gemzar stops working they will allow me to have TDM1. They aren't opening up cross over in all their trial but decided to in this one b/c we are in he "salvage" setting with few options left for Her2.

Add that to PERJETA™ (pertuzumab) being approved. Even though it said as first line, My oncologist said they can use it off label. The U of Penn will have it end of summer she said.

So from my hopeless post in March, I have added two new treatments to my arsenal. Gemzar is keeping cancer stable and has given me back my quality of life. I am eating again, off IV nutrition and my weight is stable.
I got to see my son graduate 6th grade. Which since being here for high school graduation seems like a long shot, was very meaningful for me. He turns 12 in July and I will celebrate my 5th wedding Anniversary in August and would love to take a mini vacation to shore or Lancaster this summer. So I am hoping to stay stable for awhile.
I feel lucky and blessed to be here. I was considering hospice in March.
Thank you so much for your support and help.

Re: Enrolled in T-dm1 Teresa trial
 

Thank God!!!! I am soooo happy to hear you are feeling better and things are stable. What a relief...((hugs)) to you. Please keep us updated, and know that I am sending you prayers and positive energy every day, as are many others.

Re: Enrolled in T-dm1 Teresa trial
 

So pleased to hear this good news.sending you lots of good vibes from across the pond.
Ellie

Re: Enrolled in T-dm1 Teresa trial
 

How wonderful for you! Hope springs eternal! I'm so glad your able to fully enjoy your son. He has an exceptional Mother! You and your family are in my prayers.

Re: Enrolled in T-dm1 Teresa trial
 

I'm so happy you checked in - wonderful news! Congrats to your little guy and I looked forward to seeing pictures of you with him on his next graduation!

Re: Enrolled in T-dm1 Teresa trial
 

Hello Shaysmom -

Very glad to hear that you have overcome a bad moment in time, and are looking to the future. You have a great doctor who is stepping up to the plate for you big time, and prayers have been answered.

All the best for a nice summer!

Re: Enrolled in T-dm1 Teresa trial
 

I was holding my breath all the way through just hoping you'd caught a break! My doctor always encourages me with "stable is good." So glad you had that goal of 6th grade graduation and you saw it through! Your story is very inspiring- thanks for sharing!

Re: Enrolled in T-dm1 Teresa trial
 

This is the most wonderful news. Just keep moving forward now and all the best.
karen