Featured Research

from universities, journals, and other organizations

First in-human trial of endoxifen shows promise as breast cancer treatment

Date:
December 12, 2013
Source:
Mayo Clinic
Summary:
A Phase I trial of endoxifen, an active metabolite of the cancer drug tamoxifen, indicates that the experimental drug is safe, with early evidence for anti-tumor activity, a study has found. The findings indicate that Z-endoxifen may provide a new and better treatment for some women with estrogen positive breast cancer and, in particular, for those women who do not respond to tamoxifen and aromatase inhibitors.

A Phase I trial of endoxifen, an active metabolite of the cancer drug tamoxifen, indicates that the experimental drug is safe, with early evidence for anti-tumor activity, a Mayo Clinic study has found. The findings indicate that Z-endoxifen, co-developed by Mayo Clinic Cancer Center and the National Cancer Institute (NCI), may provide a new and better treatment for some women with estrogen positive breast cancer and, in particular, for those women who do not respond to tamoxifen and aromatase inhibitors. Results of the first in-human trial were presented today during the 2013 San Antonio Breast Cancer Symposium.

"We achieved up to 60 fold higher levels of endoxifen compared to endoxifen levels achieved with the standard dose of tamoxifen," says Matthew Goetz, M.D., a Mayo Clinic oncologist and lead author of the study. "We have seen evidence for tumor regression in patients who had failed standard hormonal therapies including aromatase inhibitors, fulvestrant and tamoxifen. This is an exciting first step in the development of this drug."

Tamoxifen is a hormonal therapy that has been used for over 40 years to reduce the risk of breast cancer recurrence and to prevent breast cancer. Some prior studies have demonstrated that patients with very low levels of a critical enzyme called CYP2D6 and those with low endoxifen concentrations have a higher risk of recurrence or progression when treated with tamoxifen. In 2008, Dr. Goetz and Matthew Ames, Ph.D. at the Mayo Clinic Cancer Center began to collaborate with the NCI to develop formulations of endoxifen. This formulation, known as Z-endoxifen hydrochloride (endoxifen), was tested through preclinical pharmacology studies, toxicology workups and, most recently, clinical trials conducted at Mayo Clinic and NCI.

In the Phase I study, researchers gave endoxifen once daily to 22 women with estrogen-receptor positive breast cancer that was resistant to standard hormonal therapies such as aromatase inhibitors, tamoxifen and fulvestrant. The drug appeared to be safe even at the highest dose of 160 milligrams/day.

Dr. Goetz and his colleagues are now working to determine the optimal dose of endoxifen for breast cancer patients. After that work is complete, Dr. Goetz would like to see the drug studied in premenopausal patients where tamoxifen is the only FDA approved hormonal agent for the treatment of estrogen receptor positive breast cancer. "Endoxifen may turn out to be a better drug than tamoxifen," he says, "and not just in patients who have limited CYP2D6 metabolism. This is something that has to be prospectively tested."


Story Source:

The above story is based on materials provided by Mayo Clinic. Note: Materials may be edited for content and length.


Cite This Page:

Mayo Clinic. "First in-human trial of endoxifen shows promise as breast cancer treatment." ScienceDaily. ScienceDaily, 12 December 2013. <www.sciencedaily.com/releases/2013/12/131212185835.htm>.
Mayo Clinic. (2013, December 12). First in-human trial of endoxifen shows promise as breast cancer treatment. ScienceDaily. Retrieved September 2, 2014 from www.sciencedaily.com/releases/2013/12/131212185835.htm
Mayo Clinic. "First in-human trial of endoxifen shows promise as breast cancer treatment." ScienceDaily. www.sciencedaily.com/releases/2013/12/131212185835.htm (accessed September 2, 2014).

Share This



More Health & Medicine News

Tuesday, September 2, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Snack Attack: Study Says Action Movies Make You Snack More

Snack Attack: Study Says Action Movies Make You Snack More

Newsy (Sep. 2, 2014) You're more likely to gain weight while watching action flicks than you are watching other types of programming, says a new study published in JAMA. Video provided by Newsy
Powered by NewsLook.com
U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

Newsy (Sep. 2, 2014) The U.N. says the problem is two-fold — quarantine zones and travel restrictions are limiting the movement of both people and food. Video provided by Newsy
Powered by NewsLook.com
Doctors Fear They're Losing Battle Against Ebola

Doctors Fear They're Losing Battle Against Ebola

AP (Sep. 2, 2014) As a third American missionary is confirmed to have contracted Ebola in Liberia, doctors on the ground in West Africa fear they're losing the battle against the outbreak. (Sept. 2) Video provided by AP
Powered by NewsLook.com
Tech Giants Bet on 3D Headsets for Gaming, Healthcare

Tech Giants Bet on 3D Headsets for Gaming, Healthcare

AFP (Sep. 2, 2014) When Facebook acquired the virtual reality hardware developer Oculus VR in March for $2 billion, CEO Mark Zuckerberg hailed the firm's technology as "a new communication platform." Duration: 02:24 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins