Clinical Trial for Trip Negs w/Mets

CalGal

Hello Trip Negs -

I know most of you don't have mets and I hope you stay that way! For those of us who do, it's quite refreshing to see a targeted therapy clinical trial that is for us! I also posted this on the recurr & mets thread ... (as well as 6 mos ago or so ... but it "fell-off" the posting list).

CalGal


http://clinicaltrials.gov/show/NCT00371254


A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-Negative' Breast Cancer

This study is currently recruiting patients.
Verified by Bristol-Myers Squibb July 2007
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00371254

Purpose
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.
Condition Intervention Phase
Breast Cancer
Metastasis
Drug: Dasatinib
Phase II

MedlinePlus related topics: Breast Cancer; Cancer
Genetics Home Reference related topics: breast cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-Negative' Breast Cancer
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:

* To estimate the objective response rate (ORR) of dasatinib in women with recurrent or locally-advanced or metastatic 'triple negative' breast cancer. [Time Frame: December 2008]


Secondary Outcome Measures:

* estimate disease control rate (DCR) and proportion of free or progression, progression-free survival (PFS) distribution, and response duration. [Time Frame: December 2008]
* determine the safety and tolerability of dasatinib in this patient population [Time Frame: December 2008]
* obtain PK and PD data [Time Frame: December 2008]
* obtain preliminary pharmacogenomics data [Time Frame: December 2008]


Total Enrollment: 45

Study start: December 2006

Eligibility
Ages Eligible for Study: 18 Years and above,
Genders Eligible for Study: Female
Criteria

Inclusion Criteria:

* females, 18 or older
* recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)
* 0, 1 or 2 chemotherapies in the metastatic setting
* adequate organ function

Exclusion Criteria:

* Metastatic disease confined to bone only
* Symptomatic CNS metastasis
* Concurrent medical condition which may increase the risk of toxicity
* Unable to take oral medication

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00371254

For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

United States, California
Ucla, Los Angeles, California, 90095, United States; Recruiting
Richard Finn, Site 003

Ucsf-Comprehensive Cancer Center, San Francisco, California, 94143, United States; Recruiting
Hope S. Rugo, Site 017 415-353-7618

United States, Florida
Mayo Clinic Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Alvaro Moreno-Aspitia, Site 004 904-953-7283

United States, Illinois
Local Institution, Maywood, Illinois, 60153, United States; Not yet recruiting
Site 027

United States, Massachusetts
Dana-Farber Cancer Inst, Boston, Massachusetts, 02115, United States; Recruiting
Erica Mayer, Site 007 617-732-3000

United States, New York
Montefiore Medical Center, Bronx, New York, 10461, United States; Recruiting
Joseph Sparano, Site 016 718-904-2555

United States, Pennsylvania
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting
Lori Goldstein, Site 015 215-728-2689

United States, Texas
University Of Texas Md Anderson Cancer Ctr, Houston, Texas, 77030, United States; Recruiting
Nuhad Ibrahim, Site 005 713-792-2817

Also trials in: Belgium, France, Italy & Spain
More Information

BMS Clinical Trials Disclosure
Study ID Numbers: CA180-059
Last Updated: July 30, 2007
Record first received: September 1, 2006
ClinicalTrials.gov Identifier: NCT00371254
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on August 03, 2007

nosurrender

Thanks for posting this!
I hope you are doing ok!!

Love,
g

FloridaLady

this is a new drug that is old. was gleevic for lukeimua. you must have a -kit- receptor to be in trial. very early research.

Indigoblue

Calgal, Nosurrender, FlaLady,

I was reading about Dasatinab over a year ago, with little remarks when inquiring to my brilliant superboy onc.


Thanks for the information. Being somewhat "computerless" of late. Haven't been researching and it's becoming more difficult as the brainfog is setting in this chemo-meno-paws-brainless hazed head of mine.

I remember reading about Dasatinab having potential for causing the cancer cells to destroy themselves, and that it was already in trial...

Thanks for posting this! It's good to know what's up in the clinical trials for trip neg. What is a -kit-(cat) receptor, if you don't 'meow'ind me asking? Does it mean one has to be the Purrfect candidate to apply? I remember reading about Gleevac, as well. There were some women taking it for breast cancer, mets.

Question: How do we know, really, whether cancer has mets or not; by the time it's beyond our control, it doesn't show up on scans or bloodtests, cancer markers unreliable.
So please, I would like to know the truth; do docs have the "right" not to tell you if your cancer has mets? What are the specifics of getting into these trials? Insurance, one factor, but my oncologist claims there is nothing for triple negative trials which would be beneficial.

Sorry about the rambling...feel physically horrid, wondering why, and getting no answers from anyone after treatment. I want an MRI, they refuse. I insist, they refuse, want blood, liver, tests etc.:refused, wait and see....

If entering clinical trials, I know these tests would likely be done accurately and immediately.

Thanks

Love you all, great ladies! You've been here since I logged on in 2005. You continue to amaze my otherwise unknowledgeable sources for information; being informed, what does it take to "get all this stuff"?

The more I learn, the less I know.

((hugs))

Indi (venting helps so much!)

FloridaLady

Sorry for getting back late. Can barely type. To get in trials it depends on what drugs being tested. Toxic drugs you usually must have mets but usually not bone. Drugs like Gleevic no mets but you must measureable tumor. And it true there is nothing in resarch for triple negs that is killing cancer. only hold progresion for a short time. Kit receptor is a new one that has to be taken from biopsy. I tested positive but can not travel to Houston due to neuropthy. My flaa dc trying to get it at cost.