Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer
Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For 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 may allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| yttrium Y 90 monoclonal antibody B3 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV breast cancer * At least 1 site of relapse or metastatic disease * Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease * One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease * Prior adjuvant chemotherapy allowed * Measurable or evaluable disease * Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells * No CNS metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 2 times upper limit of normal * PT normal * Hepatitis B surface antigen negative * Hepatitis C negative Renal: * Creatinine no greater than 1.4 mg/dL Cardiovascular: * Ejection fraction at least 45% by MUGA or echocardiogram Pulmonary: * FEV\_1 greater than 60% of predicted * FVC at least 55% of predicted * DLCO at least 55% of predicted Other: * No known seizure disorders * No history of autoimmune disease * No other active malignancy except previously treated basal cell skin cancer * No other concurrent medical or psychiatric condition that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No prior mouse antibody Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered * No prior high-dose chemotherapy with bone marrow or stem cell transplantation Endocrine therapy: * At least 4 weeks since prior hormonal therapy * No concurrent chronic steroids Radiotherapy: * At least 4 weeks since prior local radiotherapy to one site and recovered * No prior radiotherapy to the pelvis and/or spine Surgery: * Not specified Other: * No concurrent anticoagulants
References
Publications (0)
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