Dr. Len's Cancer Blog

Expert perspective, insight and discussion

Dr. Len's Cancer Blog

The American Cancer Society

New Hope In Treating Triple Negative Breast Cancer

by Dr. Len June 01, 2009

One of the papers presented during yesterday afternoon’s plenary session at the annual meeting of the American Society of Clinical Oncology (ASCO) captured my attention for a couple of reasons.

 

The study reported on a new drug code named BSI-201 in a trial where the researchers treated women with a form of breast cancer called “triple negative.”  Triple negative breast cancers (or TNBC) are called that because they don’t have estrogen or progesterone hormone receptors and are negative for a genetic marker called HER2. As a result, they can’t be treated with some of the more successful breast cancer treatments such as hormonal therapy or targeted drugs such as trastuzumab (Herceptin ™),  They tend to occur in younger women and especially in African American women.  Unfortunately, they tend to be more aggressive than other forms of breast cancer.

 

This new drug acts against something called poly(ADP-ribose) polymerase-1, or PARP-1.  If you think that is a mouthful and don’t understand what it is, don’t feel bad.  Neither do I and neither did much of the audience at yesterday’s presentation.  In fact, this was so new to the doctors in the audience that they had a special tutorial in PARP-1 before they presented the data from the paper, so everyone could learn something about the science behind the drug.  Basically, this enzyme is involved in gene repair and cell proliferation, two key targets to control cancer cells.  BSI-201 inhibits PARP-1, and it is thought that it works best by adding it to certain chemotherapy drugs as opposed to using it by itself.

 

In this trial, women with TNBC with metastatic disease—a particularly difficult situation to treat—received chemotherapy with two drugs (gemcitabine and carboplatin).  Half the women received just the chemotherapy, and the other half received the drugs with the addition of BSI-201.

 

The results, in my opinion, were impressive: 62% of the women who got BSI-201 responded to the treatment compared to 48% in the “control” group that got just the standard therapy.  The time it took for the disease to progress on treatment in the women who received BSI-201 was 6.9 months, compared to 3.3 months for the women on the standard treatment arm.  The overall survival increased from 5.7 months in the control arm to 9.2 months in the BSI-201 arm.  There was no apparent increase in side effects from adding BSI-201 to the treatment program.

 

Those improvements are all significant, although obviously don’t represent the types of increased survivals we would like to see.  But as I mentioned, women with TNBC who have metastatic disease unfortunately don’t do well with current treatments, and this new drug represents a true ray of hope in a frequently hopeless situation.  I would also note that some of these women had already received prior chemotherapy, which in effect stacked the deck against seeing any success with this new drug regimen.

 

I was so intrigued by the results that I tried to find out more about the company that invented the drug.  The name of the company is BiPar Sciences.  You would think that this would be a large company to have made such a significant discovery of a drug that represents an entirely new class of therapy.

 

What I found out was that in fact the company had recently been purchased by a larger pharmaceutical company, so it is no longer a “stand alone.”  I also was told that the company still pretty much works on its own, free of much of the constraints that usually come along with being part of a much larger organization.  The number of employees who worked on this exciting discovery and clinical trial?  About 20, according to my source.

 

And, on another front, it appears that this clinical trial was done in large part through member practices of US Oncology, a nationwide oncology practice organization, not through a major university or university consortium.  So it reinforces the fact that private practices (and their patients) that commit to clinical cancer research can make significant contributions to advancing our knowledge and capabilities in cancer care.  If we could see more of this type of commitment and participation by non-academic, community based oncologists we could dramatically increase access to clinical trials and get more cancer drugs tested nationwide.

 

So here we have one of the more exciting advances in chemotherapy that I have seen in a while, and it didn’t take a giant company or major universities to get the job done.

 

For women with TNBC there is now a bit more hope that we can help them in their time of need.  The trial reported here at ASCO was what we call a phase II trial, which is essentially early stage proof-of-concept.  The next step is a phase III trial, which will treat more women, and that is scheduled to start this month.  The drug is also under investigation in other cancers as well.

 

Here's hoping that this research opens the door to a new and exciting frontier in cancer research and cancer treatment.  It clearly looks that way to me.

Comments

6/3/2009 7:23:07 PM #

susan

please inform me on the two year herceptin study that was to be presented

susan

6/5/2009 8:08:46 AM #

Deborah Benson

257916  I have TNBC and have been in treatment for almost two years. How can I partisipate or at least learn about the phase 3 trial of BSI-201?

Deborah Benson

7/6/2009 10:31:51 AM #

Gregory D. Pawelski

A clinical trial in large part through member practices of US Oncology, not through a major university or university consortium? Speaking of US Oncology, pharmaceutical spokespeople would rather have you take Abraxane (a new form of Taxol) at $4,200 a dose even though many patients can be resistant to it, develop a tolerance, limiting the drug's ability to fight future occurrences of cancer. And according to clinical trials, although it does shrink tumor in more patient, Abraxane does not help patients live longer than the old treatments. Charging $4,200 a dose for a new version of an old cancer drug. Healthcare network provider, US Oncology, played a role in getting this drug approved. According to Dr. Ramaswamy Govindan, a Washington University professor who co-authored an article in the Annals of Oncology about Abraxane, none of the new (Cremophor-free versions of Taxol) drugs had shown significant advantages over the older medicines. In general, the novel formulations so far have not stood out as distinclty superior. Remember US Oncology and pharmaceutical EPO anyone? They obused giving the drug so much that they couldn't convince Medicare otherwise. US Oncology has 15% of the Community Oncology market. When the reality of pharmaceutical EPO was exposed, US Oncology banked $8-10 million a year less than expected in their SEC Form 10-K report. According to Forbes, US Oncology has become the nation's single largest purchaser of chemotherapy drugs, spending a projected $2 billion last year. The company has attracted a swarm of critics, often nonprofit or community hospitals, alleging that US Oncology destroys the fragile local economics of the U.S. health care system.

Gregory D. Pawelski

8/6/2009 5:58:29 PM #

Clinical Trial Study Patient

This is for Deborah Benson and all interested patients diagnosed with early stage TNBC.  Some of the qualifiers to participate in this study: you must have had no previous treatment or surgery and the disease must be confined to the breast. A clinical trial with BSI-201 sponsored by BiPar is underway at Stanford University in Palo Alto, Ca.  Go to med.stanford.edu/.../detail.do?studyId=1306 for more information.
Best wishes to you, and other TNBC patients reading this.

Clinical Trial Study Patient

8/7/2009 8:51:06 AM #

Len Lichtenfeld

Deborah, I would add that the American Cancer Society provides assistance with information and enrollment on clinical trials nationwide.  You can either start the process through our website at www.cancer.org, or call our cancer information center at 800 ACS 2345.  We have a team of specialists who are devoted to working with patients looking for clinical trials.

Len Lichtenfeld

10/29/2009 11:44:12 PM #

algie

I am a blck female 53yrs of age and have triple negative breast cancer. I had surgery on the 16th of october and was asked if I wanted to shrink my tumor before my surgery but was not clear as to what this could or would do for me I was told it could shrink like ice and get smaller or it could shrink like swiss cheese making holes in it but not really shrinking it. I am wondering now if there are any trials I can Participate in now that I have already had surgey. I am suppose to start chemo on the 13th of november using TAC.

algie

10/31/2009 12:24:15 PM #

Terry

I am very concerned, it appears that Triple Negative Cancer is one of the worst kinds of breat cancer and that it is very aggressive. I was diagnose with this type of cancer as well in Oct 2009. What is the survival rate? I know there has to be something promising for us.  I pray that the clinical trials will be a great success for us.

Terry

12/16/2009 11:06:44 AM #

sharon

Im a little alarm. Why isnt there more studies and more dollars being pushed into this study. I am a black female diagnose with triple negativeBreast cancer at the age of 35. back in 10/07.  I wake up everyone like is this the day. Reading the report I know its to late for me to receive the PARP-1.  So my questions is will there be other drugs coming up soon for me.

sharon

1/1/2010 3:15:59 PM #

Connie Young

325487

On December 30, I was diagnosed with tnbc and will see my oncologist for the first time on Monday, January 4.  The tumor was under 1 cm and I had clear margins and lymph nodes were clear.  I am 58 and white.  Are the clinical trials on this still ongoing and would I be a candidate? Do I call the number above to see?  Thanks you.

Connie Young

1/29/2010 10:35:21 AM #

Darlene Scheiderman

I was diagnosed w/TNBC in December '09, and will begin TAC chemo on 2/1/10. The tumor was about 1.5 cm, and I had no invasion as per sentenial node results. I am age 62 and this is the 2nd time I have had breast cancer. I did take Tamoxifen for 5 yrs. What do you think the prognosis may be?

Darlene Scheiderman

1/29/2010 11:04:56 AM #

Len Lichtenfeld

Several of you have written me with specific questions about your cancer.  Unfortunately, I can't answer them here.  Each case is individual, and there are many factors to consider.  Your medical oncologist should be able to discuss these issues with you in the context of your general health and your illness.

As to clinical trials, our cancer information center at 800 ACS 2345 (800 227 2345) has dedicated staff that can help you determine what clinical trials are best for you.  They will review the details of your diagnosis and see what trials are available and where they are located.

Also, we have staff that can talk to you about your particular cancer, and answer your questions.

Len Lichtenfeld

2/15/2010 12:40:10 PM #

Janet Fritz

I was diagnosed with TNBC in Aug 09, thought to be 1cm no lymph nodes involved, came to UCLA Jonsson Cancer Center from FL because of the Triple Negative.  By the time lumpectomy operation was scheduled Oct 7, it was 5 cm and in 5 of 6 nodes!  This baby grows fast.  I just finished my 6th cycle of chemo and through the whole thing all Dr's have told me I am one strong lady!  I will have a mastectomy on 5 Mar and remove more lymph nodes.  Then after I heal from all that, I will have radiation 5 days a week for 7 weeks.

I am 69, white female.  No breast cancer in my history, but Dad had throat cancer.  Had mamo in May 09 and by the time I found the lump on Aug 1st of 09, it was almost the size of my thumb!  

My advice on Triple negative....Have your operation as FAST as  possible!  I lined up all the Dr's and Hospitals and things I could do but When I left Florida, I put my cure IN GODS HANDS!  God bless us all!  Janet

Janet Fritz

3/8/2010 2:46:06 PM #

Emelee

I am a survivor of triple negative breast cancer,  4 years, 4 months now.     My tumor was 3 cm,  25 lymph nodes were positive.     No cancer ever found elsewhere in my body.     I'm here to tell everyone there is hope for us.     Wonderful news that research is being done on this cancer.

Emelee

4/28/2010 9:39:32 PM #

Judy Hanson

I Have TNBC and a week after radiation I developed a rash that is Breast Cancer of the skin. I had had a double masectameny and 8 chemo treatments. They think the angry redness is coming frome a lymph node as that is all that showed in scans.I have since had one treatment with a Taxol and with Avastin last week. I have another this Week. Do You  think this is a good drug? Do I even have a prognois? Thank You

Judy Hanson

5/26/2010 6:53:34 PM #

Kristina P

I am also Triple Negative 3 and 1/2 yrs "clean".  Definitly hope for those that have this aggressive form...

Kristina P

5/27/2010 6:34:31 PM #

Lucy Jensen

I was just diagnosed with TNBC in one breast only - 2 cm - and understand that it is an aggressive cancer. I am planning on having a double masectomy next week in the hope that that is an aggressive enough response to this intruder. Am hoping lymph are clear, but not too hopeful .. anyone with clear lymph? Anyone also did the double masectomy and has a good story to share? All did chemo? thanks - a scarey time ....

Lucy Jensen

7/10/2010 5:34:20 PM #

Nora Berg

I am reading all these stories while fearing for my life!  I was diagnosed with TNBC in April, 2007, and treated with 4 mos of chemotherapy (A/C &taxol/carboplatin), then mastectomy w/ dissection which showed a 12cm tumor and 13 out of 16 lymph nodes affected . 10 wks of radiation followed with another six months of chemotherapy (avastin/taxol) roundednout the year.  I was re-diagnosed in March of this year.  On the other side, lymph nodes. 15 dissected, 4 affected, one already >3cm, although I was monitored closely. How is this possible?  Or fair?  And then I had hopes for the PAAP inhibitor drug and all it does is keep the disease away 7.7 months instead of 3.3?  I have two little boys I want to see grow up.  Will I?  What is my outlook?  Should I just give up now and spare everyone the misery of the next year or so?  I am 45..... I thought I'd make it at least to 65 but it doesn't look like it.  I hate this disease!

Nora Berg

9/26/2011 8:24:08 PM #

Debbie Brunelle 813-263-0822

I was diagnosed with TNBC in Jan  of this year, I was told that my cancer is rare however no one ever told me how rare and the chances of returning. The more research I do the worse it looks for me. My cancer was a stage one 1.7 cm and 1.5 cm away from my nipple. They told me they where treating me aggristively however how aggristive do they need to be to ensure  that in two years down the road this monster will not return in my breast or somewhere else in my boby as per the research I have done. I have only looked on ACS and Moffitt sites so I know my information is good. I am in my last week of 6 weeks of radiation, I want to know if I have a double Mastectomy will this lower my chances of it's return. I am a white female age 51 with a son getting married next yr and want to be there and see my grandchildern come into this world can someone help me??? I don't understand why this was not offered to me in the first place, they sent my mass out twice to make sure that the resutls where correct, I am being treated at the Moffitt Cancer Center in Tampa FL, how can this be somehting that they just let go, btw my lymph nodes where clear. I look forward to hearing from you.

Debbie Brunelle

Debbie Brunelle 813-263-0822

3/10/2012 12:39:22 PM #

Adrienne Frey

Please let me have your latest advice regarding treatment for negative Stage IV breast cancer that has metastasized to my bones, in too many places to be radiated. I am being infused every 3 wks with Iexmpra & Zometa. I am 70 & otherwise am in very good health.   Is there any hope?
Is there a trial that I can be enrolled in?
I will soon be moving back to Portland OR from Seattle.

Adrienne Frey

Add comment


(Will show your Gravatar icon)

biuquote
  • Comment
  • Preview
Loading



About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

MORE »

 

Recent Comments

Comment RSS