Clinical trial · Interventional
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer
Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
NCT00148707CI-TRIAL-00001043completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-2103 (Xyotax) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
Secondary outcomes (3)
- measure
- To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
- measure
- to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
- measure
- to determine the time to progression and overall survival of patients treated with CT2103.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.