Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
- 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)
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| indium In 111 monoclonal antibody BrE-3 | Radiation | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| yttrium Y 90 monoclonal antibody BrE-3 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * BrE-3 positive * Relapsed or refractory disease with tumor progression after effective therapy allowed * Measurable or evaluable disease * Received at least one prior chemotherapy regimen for metastatic disease and have at least one of the following: * Chemotherapy refractory liver metastases more than 2 cm * Multiple non-resectable liver metastases * Brain metastases * Prior high-dose chemotherapy * Relapse within prior radiotherapy field * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Male or female Menopausal status: * Not specified Performance status: * 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm3 * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 2 times normal * SGOT/SGPT less than 2 times normal Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * LVEF greater than 45% by MUGA scan Pulmonary: * DLCO and FEV 1.0 greater than 60% predicted Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to E. coli derived proteins * No other comorbid condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy with autologous peripheral blood stem cell transplantation Chemotherapy: * See Disease Characteristics * See Biologic therapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * Recovered from prior therapy
References
Publications (0)
Data not yet available