Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer
Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
1 other identifier
interventional
45
1 country
2
Brief Summary
The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Oct 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 21, 2007
December 1, 2007
2.9 years
September 7, 2005
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
Secondary Outcomes (3)
To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
to determine the time to progression and overall survival of patients treated with CT2103.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
- Age greater than 18 years
- At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
- HER2-negative breast cancer
- Up to one prior chemotherapy for advanced or metastatic disease
- ECOG performance status 0-1
- Life expectancy \> 12 weeks
- Adequate liver and bone marrow function: AST \< 2.5 x ULN; Bilirubin \< 1.5 x ULN; ANC \> 1,500/ul; platelet count \> 100,000/ul; normal PT and PTT
- At least 2 weeks since prior radiation and recovered from treatment-related toxicity
You may not qualify if:
- Prior taxanes for treatment of metastatic disease
- Pregnant of breast-feeding women
- HER2-positive breast cancer
- More than 1 prior chemotherapy regimen for metastatic disease
- Untreated brain metastases
- Concurrent radiotherapy or investigational drug
- Prior bone marrow or stem cell transplant
- History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
- Uncontrolled infection
- Active bleeding, or history of bleeding requiring transfusion
- Active cardiac disease
- Serious medical or psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence N. Shulman, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
October 1, 2004
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12