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Breast Cancer Treatments Show Promise in Mid-Stage Trial

Study matches therapies to patients (December 26)

The I-SPY 2 trial, a randomized phase II study in patients with breast cancer, has reported promising findings with two experimental therapies.

The new data — presented recently at the San Antonio Breast Cancer Symposium — show that when added to standard presurgery chemotherapy, the molecularly targeted investigational drug veliparib (AbbVie Inc.) in combination with carboplatin improved the rate of tumor response in patients with triple-negative breast cancer — a cancer in which the most successful treatment targets (estrogen, progesterone, and HER2 receptors) are not present.

Additional data from the study highlighted another experimental drug, neratinib (Puma Biotechnology), which was considered to have a high probability of success in phase III trials, with a signature of HER2-positive/HR-negative disease (positive for the HER2 receptor, but negative for estrogen and progesterone receptors).

The I-SPY 2 trial uses a unique adaptive design to match experimental therapies with patients. Genetic or biological markers (biomarkers) from individual patients’ tumors are used to screen promising new treatments, identifying which treatments are most effective in specific patients. Eligible patients enrolled in the study are randomly assigned to receive standard neoadjuvant chemotherapy, including paclitaxel (Taxol, Bristol-Myers Squibb), followed by anthracycline-based chemotherapy, or paclitaxel in combination with a novel agent followed by anthracycline-based chemotherapy before surgery.

“The I-SPY 2 trial has the ability to stop assigning a therapy to subtypes of patients for whom it is offering no benefit, while at the same time increasing its use to other subtypes where it is performing very well,” said co-principal investigator Donald A. Berry, PhD.

Source: FNIH; December 26, 2013.

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