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Experimental Breast Cancer Drug Seems Safe

Preliminary results look promising, experts say

WebMD News from HealthDay

By Steven Reinberg

HealthDay Reporter

SUNDAY, April 6, 2014 (HealthDay News) -- In an early trial, an experimental breast cancer drug stopped disease growth and shrank tumors by more than 30 percent in some patients.

The pill, bemaciclib, was safe and well-tolerated by women with breast cancer that had spread, or metastasized, to other parts of the body, according to the results of this phase 1 trial.

"This is a novel oral treatment for patients with metastatic breast cancer," said lead researcher Dr. Amita Patnaik, the associate director of clinical research at South Texas Accelerated Research Therapeutics in San Antonio.

If these results are replicated in future trials, it's conceivable that the pill might extend survival for women with terminal breast cancer, experts suggested.

The drug was particularly effective for the most common type of breast cancer, called hormone receptor-positive breast cancer. In this type of cancer, cancer cells grow in response to signals from the hormones estrogen and/or progesterone.

The study included more than 130 women. Overall, Patnaik said half of them had cancer growth controlled and 25 percent had shrinkage of their tumors.

Unlike standard cancer drugs, this is a twice-daily pill that allows women to go on with their daily lives. In contrast, other cancer drugs are given intravenously at a hospital or doctor's office. Another difference, Patnaik said, is that bemaciclib is a targeted therapy, a newer type of drug that is better able to identify and attack specific cells.

"Our results show that it can be given safely over a long period of time, and patients are able to go on with their routine activities and have a good quality of life," she said.

Side effects of the drug include diarrhea, nausea and vomiting. For study participants, most of these problems were mild or moderate, Patnaik said.

The trial results were scheduled for presentation Sunday at the annual meeting of the American Association for Cancer Research in San Diego. The study was funded by Eli Lilly and Co., the maker of bemaciclib.

"It is important to remember that this is a first-time evaluation of the drug and these results will have to be confirmed in later studies," Patnaik cautioned. More trials are being planned, she said.

Dr. Neelima Denduluri, a medical oncologist at Virginia Cancer Specialists in Arlington, pointed out that metastatic breast cancer is generally incurable. "Goals of therapy include maintaining quality of life while administering effective therapy," said Denduluri, who was not involved in the study.

She said she hopes bemaciclib and other new drugs will make a difference in the treatment of advanced breast cancer.

For hormone receptor-positive breast cancer, doctors often use anti-estrogen therapies. However, tumor cells stop responding to these drugs, so alternatives are often needed, Denduluri said.

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