['lizbeth]

NCT00195091



Email from Advocate Amy B. October 2008:

I would like to share this clinical trial with the advocate community and make sure that everyone who is eligible knows about the trial.

Dr. Vahdat is my oncologist and I would encourage anyone interested to get in touch with her directly. I am including the general description of the trial and I am sure she will answer any specific questions. This is a general and very basic overview.

A Phase II study of Tetrathiomolybdate (TM) in women with breast cancer at moderate to high risk of relapse.

Linda Vahdat, MD

NCI.gov clinical trials #:NCT00195091

Eligible patients: Patients with Stage 3 breast cancer or Stage 4 breast cancer with no evidence of disease who have completed what is considered standard therapy for their cancer. Hormonal treatments are allowed. Concurrent trastuzumab is not allowed.

Trial: The goal of this clinical trial is to try to keep breast cancer cells in a dormant state by depleting copper, an essential component to helping them come out of dormancy.

Background information: The observation that has always puzzled researchers is why a patient can relapse with cancer after many years of being cancer-free.

Similarly, in patients whose cancer has spread, why can a treatment that removes all visible traces of breast cancer recur again? Multiple lines of evidence point to the fact that cancer cells lie dormant awaiting for a "signal" to start growing. It is believed that a crucial part of this "signal" is the ability to recruit blood vessels to the dormant tumor cell so that it can lay down blood vessels to feed itself and spread.

This signal has been termed the "angiogenic switch". There are many compounds being tested that might affect the turning on of this "angiogenic switch". These are called anti-angiogenesis agents. It is well known that copper plays an essential role in the angiogenic process. People who have breast cancer tend to have higher copper levels than those who do not.

We will be studying controlled copper depletion, a process where you lower the copper level in the body to the level where normal cellular processes can take place but tumor angiogenesis cannot. This process has been tried with patients with advanced cancer and the preliminary results support the hypothesis of this clinical trial.

Practical information: This trial is being conducted at

Weill Medical College of Cornell University by the Breast Cancer Research group.

This trial consists of taking TM pills ( an anti-copper agent) for two years. For the first 6 weeks, one must visit our office once every 2 weeks for 3 visits. This is to make sure that the copper levels do not go too low. After that, a once a month visit is required.

If you would like more information please contact:

The office number until November 1: 212-746-7332 then 212-821-0644

Diana Donovan, ANP: donovdi@med.cornell.edu

Marta Cobham, RN (research nurse): mac2034@med.cornell.edu

Linda Vahdat, MD: ltv2001@med.cornell.edu



This trial is supported by the Susan B Komen for the Cure, Breast Cancer Alliance of Greenwich and the NY Community Trust.

Remember we are NOT Doctors and have NO medical training.