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AACR Highlights: Clinical Trials

By BCRF | April 21, 2016

Noteworthy clinical trial news from the annual conference

It’s been an exciting week at AACR. Here are a few highlights from clinical trials in breast cancer reported at Monday’s session.


​​A Presurgery Combination Therapy May Improve Outcomes for Women With HER2-positive Breast Cancer

Results from the I-SPY 2 clinical trial show that the combination of T-DM1 with the anti-HER2 drug pertuzumab was more effective than the standard therapy of paclitaxel and traztuzumab in the pre-surgical (neoadjuvant) setting, substantially improving the pathological complete response (pCR- meaning no tumor was detectable after the pre-surgical treatment) compared to the paclitaxel/traztuzumab regimen.

The I-SPY trial is a Phase II adaptive randomized neoadjuvant trial. This is a novel clinical trial concept in which multiple drugs can be tested simultaneously without designing a new trial for each drug. Patients are matched to a drug based on the characteristics of their tumor. This unique trial platform allows drugs to be added or removed from the trial quickly. Drugs that do well “graduate” to Phase III testing more rapidly than in the traditional clinical trial system.

According to Laura Esserman, co-principal investigator for I-SPY and BCRF investigator, “The I-SPY approach is designed to reduce the cost, time and number of patients needed to identify effective drugs and the patients most likely to respond to them and to accelerate FDA approval of these therapies.”

In the current analysis, patients with early-stage HER2-positive breast cancer were randomized to 12 weeks of the standard therapy of paclitaxel plus traztuzumab or TDM-1 plus pertuzumab. Both combinations were followed by 4 weeks of docetaxel/cyclophosphamide and then surgery.

Prior studies have shown the T-DM1/pertuzumab combination to be effective in advanced HER2-positive breast cancer. This study shows for the first time that it is also an effective regimen for early stage HER2-positive breast cancer.

While additional Phase III testing is necessary to confirm these findings, Dr. Angela DeMichele, lead author on the study commented: “These data provide a possible new treatment option for patients newly diagnosed with HER2-positive breast cancer that can not only shrink the tumor but potentially reduce the change of the cancer coming back later.”

Read the press release here.

Palbociclib Showed Antiproliferative Activity in Early-stage Breast Cancer

Results from a Phase II clinical trial showed that a short-term treatment with the CDK4/6 inhibitor palbociclib prior to surgery decreased the growth of tumors in patients with different subtypes of breast cancer. The study included 100 women diagnosed with early stage breast cancer, 74 of which received palbociclib for 14 days prior to surgery and 24 who received no treatment. The researchers found that the tumors in women receiving palbociclib had less of a protein called Ki67 – a marker of tumor growth. While the study is too small to derive conclusions about the benefit of palbociclib in this setting, if the findings are confirmed in a larger population, it would provide a potential new treatment options for early-stage breast cancer. Additional biomarker studies are ongoing with support from BCRF.

Read the press release here

​Breast Cancer Risk Prediction Models Improved by Adding Multiple Biological Markers of Risk

Risk prediction models are important tools in assessing breast cancer risk for early preventive measures. The current models typically include standard breast cancer risk factors, such as age, family history of breast cancer and number of births (parity). In a study reported at AACR, a new model that included a genetic risk score, mammographic density and postmenopausal endogenous hormone levels (without the use of supplemental hormones, such as hormone replacement therapy – HRT) improved the risk assessment, especially in postmenopausal women not taking HRT. The study included over 22,000 pre- and post-menopausal women who participated in the Nurse’s Health Study.

Read the press release here.