Study shows new paradigm in breast cancer research

December 13, 2013

MAYWOOD, Ill. - The first investigator results from an unprecedented nationwide effort to test promising new breast cancer drugs before the tumor is removed were presented during the 2013 San Antonio Breast Cancer Symposium.

The research initiative, called I-SPY 2, employs an innovative clinical trial design in the curative setting that is enabling researchers to quickly drop drugs and drug combinations that don't work, while fast-tracking effective regimens for further study.

The first drug to graduate out of this innovative research design is veliparib, which was added to standard chemotherapy (carboplatin and paclitaxel) given to women with high-risk breast cancer. Kathy Albain, MD, of Loyola University Medical Center, is among the co-authors of the trial, and Loyola enrolled patients in the trial.

In a traditional clinical trial of treatment after definitive breast cancer surgery, the veliparib/carboplatin/paclitaxel regimen would have been tested on a very large and broad population of high-risk patients whose tumors are designated HER2-. (In a HER2- tumor, the cancer cells do not have a surface receptor protein known as HER2 -- Human Epidermal growth factor Receptor 2.)

In I-SPY 2, women received the veliparib/carboplatin/paclitaxel combination prior to surgery, and response rates to the drugs were determined by examining tumor specimens removed during surgery. Researchers then used a statistical model to predict which subset of patients would most likely benefit in a follow-up small Phase 3 clinical trial. In this way, new drugs can get to patients much faster than in the traditional approach.

In this trial, researchers estimated that the subset of patients with "triple negative" breast cancer had the greatest benefit from the addition of veliparib, as well as a 91 percent probability of success in the confirmatory small Phase 3 trial. (Triple negative means that neither HER2, estrogen or progesterone receptors are present on cancer cells.)

By comparison, there was only a 70 percent probability of success for all HER2- patients and only a 16 percent probability of success for HER2- patients whose cancer cells showed estrogen or progesterone.

Researchers concluded that the veliparib/carboplatin/paclitaxel regimen should be further tested in the confirmatory phase 3 trial, but only in patients with triple negative breast cancer. The innovative I SPY 2 design enabled researchers to make this recommendation based on a modest number of subjects - 72 patients who received veliparib/carboplatin/paclitaxel, and 62 patients who were randomly assigned to a control group without veliparib.

"I-SPY 2 is a new paradigm in breast cancer clinical trials," Albain said. "The veliparib/carboplatin/paclitaxel study is a great example of how I-SPY 2 can tell us, as rapidly as possible, which drugs work best on different types of tumors. This could prove to be an enormous benefit to patients, especially women with the most aggressive cancers."

Loyola is one of the I-SPY 2 site locations, and Albain is principal investigator at the Loyola site. Loyola also participated in an I-SPY 2 clinical trial of a second drug, neratinib, that also has graduated for further study.
-end-
Albain is a professor in the Division of Hematology/Oncology of Loyola University Chicago Stritch School of Medicine and directs Loyola's breast clinical research program.

I-SPY 2 is led by the Foundation of the National Institutes of Health and is sponsored by the Biomarkers Consortium, a unique public-private partnership that includes the Food and Drug Administration, National Institutes of Health and major pharmaceutical companies.

Loyola University Health System

Related Breast Cancer Articles from Brightsurf:

Oncotarget: IGF2 expression in breast cancer tumors and in breast cancer cells
The Oncotarget authors propose that methylation of DVDMR represents a novel epigenetic biomarker that determines the levels of IGF2 protein expression in breast cancer.

Breast cancer: AI predicts which pre-malignant breast lesions will progress to advanced cancer
New research at Case Western Reserve University in Cleveland, Ohio, could help better determine which patients diagnosed with the pre-malignant breast cancer commonly as stage 0 are likely to progress to invasive breast cancer and therefore might benefit from additional therapy over and above surgery alone.

Partial breast irradiation effective treatment option for low-risk breast cancer
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast irradiation for many women with low-risk, early stage breast cancer, according to new clinical data from a national clinical trial involving researchers from The Ohio State University Comprehensive Cancer Center - Arthur G.

Breast screening linked to 60 per cent lower risk of breast cancer death in first 10 years
Women who take part in breast screening have a significantly greater benefit from treatments than those who are not screened, according to a study of more than 50,000 women.

More clues revealed in link between normal breast changes and invasive breast cancer
A research team, led by investigators from Georgetown Lombardi Comprehensive Cancer Center, details how a natural and dramatic process -- changes in mammary glands to accommodate breastfeeding -- uses a molecular process believed to contribute to survival of pre-malignant breast cells.

Breast tissue tumor suppressor PTEN: A potential Achilles heel for breast cancer cells
A highly collaborative team of researchers at the Medical University of South Carolina and Ohio State University report in Nature Communications that they have identified a novel pathway for connective tissue PTEN in breast cancer cell response to radiotherapy.

Computers equal radiologists in assessing breast density and associated breast cancer risk
Automated breast-density evaluation was just as accurate in predicting women's risk of breast cancer, found and not found by mammography, as subjective evaluation done by radiologists, in a study led by researchers at UC San Francisco and Mayo Clinic.

Blood test can effectively rule out breast cancer, regardless of breast density
A new study published in PLOS ONE demonstrates that Videssa® Breast, a multi-protein biomarker blood test for breast cancer, is unaffected by breast density and can reliably rule out breast cancer in women with both dense and non-dense breast tissue.

Study shows influence of surgeons on likelihood of removal of healthy breast after breast cancer dia
Attending surgeons can have a strong influence on whether a patient undergoes contralateral prophylactic mastectomy after a diagnosis of breast cancer, according to a study published by JAMA Surgery.

Young breast cancer patients undergoing breast conserving surgery see improved prognosis
A new analysis indicates that breast cancer prognoses have improved over time in young women treated with breast conserving surgery.

Read More: Breast Cancer News and Breast Cancer Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.