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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.
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