Breast CancerPhase 2NCT00148707
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer
A Phase 2 study testing CT-2103 (Xyotax) in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- CT-2103 (Xyotax)
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2004to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
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.
Read the detailed description
- Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
- Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
- Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
- Additional blood work will be performed once per week after the first two doses of CT-2103.
- The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- CT-2103 (Xyotax)
- Keywords
- Metastatic Breast Cancer, HER2-negative Breast Cancer, CT-2103, Xyotax
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-2103 (Xyotax)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence N. Shulman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148707
- Sponsor's protocol ID
- 04-299
- Status last verified
- Dec 2007
- First submitted
- 7 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00148707
- Acronym / sponsor ID
- 04-299
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, HER2-negative Breast Cancer, CT-2103, Xyotax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- Oct 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
- Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
- Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
- Additional blood work will be performed once per week after the first two doses of CT-2103.
- The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-2103 (Xyotax) | Drug | – |
Primary outcome
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence N. Shulman, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-2103 (Xyotax) in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.