Clinical trial · Interventional
Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients
Phase I Study of Local Radiation and CP-675,206 Administration in Patients With Inoperable Locally Recurrent or Metastatic Breast Cancer
NCT01334099CI-TRIAL-00018328terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Contract with drug supplier expired and was not renewed.
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 | Biological | Tremelimumab | ALIAS |
| External local radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation combined with CP-675,206
- interventionNames
- Biological: CP-675,206
- Radiation: External local radiation therapy
Primary outcomes (1)
- measure
- Assessing safety through toxicities observed using CTCAE version 3.0
- timeFrame
- At each study visit for the duration of the 12-week cycle
Secondary outcomes (2)
- measure
- Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0)
- timeFrame
- Every 8 weeks after treatment
- measure
- Immunological responses to the treatment measured through analysis of blood draws
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable locally recurrent or metastatic breast cancer * Performance status 0-1 * Adequate organ function as determined by lab tests * Greater than 3 weeks since any chemotherapy treatment * Greater than 2 weeks since last dose of hormonal therapy Exclusion Criteria: * Previous treatment with any anti-CTLA4 agent * Patients with active diarrhea * Patients who will receive radiation to pelvic lesions * History of chronic inflammatory or autoimmune disorder * History of insulin-dependent diabetes * History in the last 5 years of any chronic gastrointestinal conditions * History within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event * Patients with known brain metastasis * Concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial * Patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.