New study could speed up approval for breast cancer drugs

5:55 PM, Oct 11, 2010   |    comments
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MINNEAPOLIS -- People walk in events like Race for the Cure to raise money for breast cancer research.

The tough part can be finding patients to participate in those clinical trials. Now there's a new nationwide study that could speed up how quickly breast cancer drugs are approved. Researchers at the University of Minnesota need patients to sign up.

Ann Harris has participated in a clinical trial.  She was diagnosed ten years ago with an aggressive HER2-positive breast cancer.  

Those with this kind of cancer have cells with extra HER2 genes that produce too much of a protein that can speed up the production of cancer cells. So she signed up for a clinical trial.  

Like most clinical trials, Harris had the standard of care, which for her was chemotherapy and radiation.  And she also took the experimental drug Herceptin for one year.  She said it worked great for her.

Harris said, "I don't think I'd be alive today without Herceptin."

The research showed it worked great for others as well.  Herceptin was FDA approved four months after Harris completed her treatment.

Since then, Harris co-founded the Breast Cancer Awareness Association, to help educate those with breast cancer about the disease and treatment options.  She wants others to participate in clinical trials.

She said, "We are not going to advance the cure of this disease and other diseases unless we get people involved in clinical trials."
Dr. Tufia Haddad is a medical oncologist at the University of Minnesota's Masonic Cancer Center. She said, "When we look across the nation at how many cancer patients participate in clinical trials at any time that number is only three percent.  It's about ten percent for women with breast cancer."

While there is always breast cancer research going on at the University of Minnesota Masonic Cancer Center, Haddad is leading up a new trial which begins this month for which researchers are seeking participants.  

It's called the I-SPY 2 trial. Dr. Haddad says it took 15 years for Herceptin to get FDA approval.

So she said the goal of the I-SPY 2 trial is, "Looking to shrink down the time to evaluate a single drug down to one or two years."

In the trial, breast cancer drugs already tested for safety will then be tested on those with early stage cancers.  Haddad said this skips the traditional step of testing them on those with advanced stage 4 cancers first.  Haddad said, "So giving these drugs to women with potentially curable breast cancer right up front."  Researchers will use biomarkers to see if patients could benefit from certain investigational new drugs.

Haddad said it could completely change the paradigm for how new cancer drugs are tested.  

Now she just needs breast cancer patients like Harris to participate.

Harris said, "Herceptin was like liquid gold to me."

Haddad will be speaking Saturday, Oct. 9, at the Living with Breast Cancer conference which is put on by the Breast Cancer Awareness Association and is being held at the Minneapolis Convention Center.  

Those interested in the I-SPY 2 trial can call 612-624-2620 or check out the U of M Masonic Cancer Center website,

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