A new cancer treatment that links chemotherapy with an agent that homes in on specific breast cancer cells was significantly better than the current drug regimen（养生法，政体） at keeping patients' advanced tumors from progressing, according to results from a Phase III clinical trial led by Kimberly Blackwell, M.D., of the Duke Cancer Institute. Participants with invasive breast cancer who took the investigational² drug, called trastuzumab emtansine, or T-DM1, also had fewer and less harsh side effects than study participants who received a standard treatment.

The findings were reported June 3 at the American Society of Clinical Oncology annual meeting in Chicago, and will form the basis for Genentech, the drug's manufacturer, to seek marketing³ approval from the U.S. Food and Drug Administration. Genentech and its parent company, Roche funded the clinical trial.

"This drug is significantly better than the current approved combination in keeping the cancer under control," said Blackwell, director of the Breast Cancer Clinical Program at Duke and principal investigator⁴ of the international study. "This is a drug that brings us another step closer to treating cancer without the side effects of chemotherapy. It's going to be a good option for patients faced with HER-2 positive tumors."

Nearly 1,000 people with advanced breast cancer were enrolled⁵ during the three-year study. All the participants had a form of aggressive breast cancer distinguished⁶ by elevated levels of a protein known as human epidermal⁷（表皮的） growth factor receptor 2, or HER-2. The protein promotes the growth of cancer cells, and plays a role in about 20 percent of invasive breast cancers.

For many people with HER-2 positive breast cancers, an antibody called trastuzumab has been an effective treatment, binding⁸ to the HER-2 protein on the surface of cancer cells and interfering⁹ with its ability to fuel tumor¹ growth. Trastuzumab is prescribed alone or as an added treatment along with chemotherapy drugs.

T-DM1 represents one of the first in a new class of cancer-fighting agents called antibody drug conjugates¹¹. Linking the antibody trastuzumab directly with chemotherapy, the conjugate¹⁰ works like a sort of smart bomb, homing in on the HER-2 targets in the tumor cells and delivering the added payload of chemotherapy.

Blackwell and colleagues report that the median amount of time people on T-DM1 had no cancer growth was 9.6 months, compared to a median 6.4 months for people receiving the current standard drug regimen of capecitabine and lapatinib.